Quality Control Products & Services Catalog

Transcription

1 Bio-Rad Laboratories quality control Quality Control Products & Services Catalog Dedicated to Advancing QC Solutions Worldwide

2 Note to the Reader To make navigation easier, this PDF contains internal links. All Table of Contents pages include links to Catalog Sections, individual products, charts, or other listed content. Catalog Sections and Topics of Interest are Bookmarked; open the Bookmarks menu to view and use these links. Use the Catalog Indexes (either Alphabetical or Catalog Number) to link directly to a specific product page. Click on the product name in the header of any Analyte, Controls for Popular Instrument Chart or POCT chart to link to the specific product page. All page number references contain links to the relevant page (Examples: See page 124 for helpful product accessories, For Liquichek D-dimer Controls, see page 88. ) URLs and QR codes included in the Catalog contain links to the web page (Internet access required)

3 How to Place an Order For Ordering Within the United States By Phone Monday Friday 6:00 AM to 4:30 PM Pacific Standard Time (PST) By Fax or By Mail Bio-Rad Laboratories, Inc. Clinical Diagnostics Group Customer Services 4000 Alfred Nobel Drive Hercules, CA By Be Sure Your Order Includes Purchase order number, ship to address and bill to address, catalog number, product name, quantity required (unit and size), desired lot number and the required delivery date. To avoid duplicate shipments, confirming orders must be clearly marked Confirming Order/Do Not Ship. Standing Orders We are happy to set up standing orders for a specific lot of product to be shipped on scheduled dates. Shipment dates and quantities to be shipped must be specified on a purchase order or standing order at the time of order. All standing order shipments must be taken six months before the product s expiration date. Restocking charges will apply to canceled standing orders. Terms of Sale Our terms are net due 30 days from the date of invoice. Prices are FOB shipping point. For a complete listing of terms and conditions regarding quantity, pricing, applicable taxes, delivery, discrepancies, returned goods and cancellation policies, please contact our Customer Service Department. For Worldwide Customers For service outside the United States, please refer to the inside back cover of this catalog for the Bio-Rad location nearest you.

4 Table of Contents How to Place an Order.... Inside Front Cover Recommended Products by Lab Area New Products Important Topics of Interest Third Party Controls, Patient Risk Management, Controls for Point of Care Testing, Controls for Popular Instruments, My einserts and Value Assignment Program Quality Services Product Support...14 Education Quality Control Products & Services QC Data Management Solutions External Quality Assurance Services (EQAS ) Immunoassay Controls Therapeutic Drug Monitoring Controls Serum Chemistry, Urine Chemistry Controls & Urinalysis Controls Cardiac Assessment Controls Immunology/Protein Controls Diabetes/Hemoglobin Controls Hematology & Coagulation Controls Blood Gas Controls Toxicology: Drugs-of-Abuse and Specialty Controls Molecular Controls Infectious Disease Controls Product Resources Accessories, Safety & Labeling Controls for Popular Instrument Charts Controls for Point of Care Testing Chart Control Analyte Indices Indices Bio-Rad Worldwide Offices... Inside Back Cover 1

5 Recommended Products by Lab Area Quality Controls for Every Area of the Laboratory Suggested controls to suit your needs, based on the specialties listed here. Core Chemistry Laboratory External Quality Assurance Services (EQAS ) Clinical Chemistry (Monthly), Urine Chemistry, Immunoassay (Monthly), Tumor Marker, Serum Proteins, Hemoglobin, Cardiac Markers, Ethanol/Ammonia and Lipids Programs Immunoassay Controls Liquichek and Lyphochek Immunoassay Plus, Liquichek Specialty Immunoassay, Lyphochek Anemia, and Liquichek and Lyphochek Tumor Marker Controls Serum Chemistry and Urine Chemistry Controls Liquid Assayed and Unassayed Multiqual, Liquid Multiqual Premium, Lyphochek Assayed and Unassayed Chemistry, Liquichek Unassayed Chemistry, Liquichek Lipids, Liquichek Pediatric and Liquichek Ethanol/Ammonia Controls Cardiac Assessment Controls Liquichek Cardiac Markers Plus and Plus LT, Liquichek Cardiac Markers LT and LT Level Low, Liquichek CK/LD Isoenzyme and Liquichek Homocysteine Controls Immunology/Protein Controls Liquichek Immunology, Liquichek Elevevated CRP, Liquichek Rheumatoid Factor and Liquichek Spinal Fluid Controls Diabetes/Hemoglobin Controls Liquichek and Lyphochek Diabetes Controls, and Lyphochek Hemoglobin A1C Linearity Set Special Chemistry/Toxicology Laboratory External Quality Assurance Services (EQAS ) Immunoassay (Monthly), Tumor Marker, and Therapeutic Drug Monitoring Programs Immunoassay Controls Liquichek and Lyphochek Immunoassay Plus, Liquichek Specialty Immunoassay, Lyphochek Anemia, and Liquichek and Lyphochek Tumor Marker, Lyphochek Maternal Serum, Lyphochek Fertility, Lyphochek Hypertension Markers, and Lyphochek Endocrine Controls Therapeutic Drug Monitoring Controls Liquichek and Lyphochek Whole Blood Immunosuppressant, and Liquichek and Lyphochek Therapeutic Drug Monitoring (TDM) Controls Toxicology: Drugs-of-Abuse Controls Liquichek Opiate, Liquichek Qualitative Urine Toxicology, Liquichek Urine Toxicology Negative and Lyphochek Urine Toxicology Controls; Liquichek Urine Toxicology Screen and Confirmatory Controls Toxicology: Specialty Controls Lyphochek Whole Blood, Lyphochek Benzo/TCA Sets A & B, and Lyphochek Drug Free Serum 2 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

6 Recommended Products by Lab Area Serology/Immunology Laboratory Immunology/Protein Controls Liquichek and Lyphochek Immunology, Liquichek Elevated CRP and Liquichek Rheumatoid Factor Controls Autoimmune Controls Infectious Disease Controls Hepatitis and Retrovirus, Congenital/Pediatric Disease, Sexually Transmitted Disease and Specialty Infectious Disease Controls Urinalysis/Hematology/Coagulation Laboratory External Quality Assurance Services (EQAS ) Hematology and Coagulation Programs Urinalysis Controls Liquichek Urinalysis, quantify and quantify Plus Controls Hematology & Coagulation Controls Liquichek Hematology (A), (C), (S), (X), 16 and 16T Controls; Liquichek Reticulocyte (A), (A-I), (C), (S) and (X); Liquichek Sedimentation Rate, Lyphochek Coagulation, Lyphochek Hemostasis and Liquichek D-dimer Controls Respiratory Care Laboratory External Quality Assurance Services (EQAS )...39 Blood Gas Program Blood Gas Controls Liquichek Blood Gas, Liquichek Blood Gas Plus E, Liquichek Blood Gas Plue EGL and Liquichek Blood Gas Plus CO-Oximeter (800 Series) Controls Visit myeinserts.com to view product inserts online, anytime. 3

7 Introduction Bio-Rad Laboratories Developing Innovative Quality Control Products and Systems for over 35 Years Bio-Rad Laboratories is committed to providing its customers a comprehensive portfolio of quality products, data management solutions, educational services and customer support. Bio-Rad Laboratories continues to advance and improve, with products, systems, and customer support services to attain higher levels of technological achievement. Our dedicated efforts in the attainment of these goals helps ensure that our customers will be able to have a confident, long-term relationship with Bio-Rad, knowing that we are dedicated to continuously providing their laboratories with quality products and services in the years ahead. Bio-Rad has served clinical laboratories for over 35 years with a reputation as a company that provides innovative quality control products and responsive service. Today, Bio-Rad is a global organization that employs more than 6,900 people in a worldwide network of operations to serve more than 100,000 research and industry customers. Even as we strive to advance and improve the experience of our customers, we commit equally to advancing the scope of our operations to improve the professional experiences of our employees so together we are aligned as a company for future levels of technological and operational achievement. 4 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

8 New Products Bio-Rad's offering of products and services now includes these New and Enhanced Products: Unity Alert Page 28 QCNet.mobi Page 30 New EQAS Programs Pages 37, 39 & 40 Serum Proteins, Tumor Marker, Blood Gas, Cardiac Markers, Coagulation, Ethanol/Ammonia & Lipids Liquichek Whole Blood Immunosuppressant Control Page 51 Controls for Use on the Vista Dimension Pages 55, 59, 61, 65, 73 & 76 Liquid Assayed Multiqual (p.55), Liquichek Pediatric Control (p.59), Liquichek Ethanol/Ammonia Control (p. 59), Liquichek Urine Chemistry Control (p.61), Liquichek Cardiac Markers Control LT (p.65), Liquichek Spinal Fluid Control (p.73), Liquichek Diabetes Control (p.76) Liquid Assayed Multiqual Premium Page 56 ENHANCED Liquichek Cardiac Markers Plus Control LT Page 65 ENHANCED Liquichek Homocysteine Control Page 66 ENHANCED Liquichek D-dimer Control Page 88 Liquichek Urine Toxicology Controls, Levels S1O & S2O; S1O & S2O Low Opiate Page 96 ENHANCED VIROTROL HIV-1 Ag Page 115 VIROTROL Syphilis LR-A & LR-B Page 119 Visit myeinserts.com to view product inserts online, anytime. 5

9 Third Party Controls I trust Bio-Rad controls because they have not been formulated for only one specific test system. Lab Manager, France Standards and Guidelines Around the World Recommend the Use of Third Party Controls Independent third party controls help provide an unbiased assessment of method or system performance. Third party controls are formulated independently from system manufacturer s calibrators and controls. The benefit is that these controls are not limited to use with specific instruments or reagent lots; consequently, they help provide an unbiased assessment of method or system performance. Third party controls are superior indicators of the validity of your complete analytical process and thus, for patient safety. Bio-Rad s human based controls provide results similar to patient samples, yet have the benefit of extended stability and long-term use to allow quality monitoring across different lots of reagents. Beyond improving aspects of your laboratory s test system performance, independent controls can provide cost savings benefits a control with multiple analytes permits consolidation. Using multi-analyte controls helps minimize QC set-up, streamlines work flow, and reduces storage and other inventory issues. Between our complete portfolio of controls for chemistry, immunoassay and infectious disease methods and our Unity Interlaboratory information management packages, we have a QC solution to suit your needs. Regulatory standards and guidelines from around the world establish the definition of third party controls... quality control materials should be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of the measurement procedure s performance in its entirety, including the procedure for calibration of the measurement. CLSI C24-A3, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline Third Edition, Relation to Calibrators The use of controls independent of those produced by the manufacturer of the test or analyzer is preferable Laboratory Accreditation Scheme of Malaysia, Quality Control Controls independent of those produced by the manufacturer of the test or analyzer should be used. The laboratory must have a system of long-term monitoring of internal quality control results to assess method performance. NATA (National Association of Testing Authorities) AS 4633 (ISO 15189), Australia, Internal Quality Control Medical laboratories shall perform internal quality control. Use of third party human matrix quality control is recommended for all analytes. Essential Standards for Registration of Medical Testing Laboratories in India, Quality Council of India, Quality Assurance 6 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

10 Patient Risk Management Don t Leave your Patients Vulnerable with a One-size-fits-all QC Approach The risk management process endeavors to minimize the chances of reporting incorrect patient results. What does Risk Management mean for patient care in the laboratory? Are my QC practices adequate? Should QC practices change when replacing analyzers? How should QC frequency be determined? If you re asking yourself these types of questions, you re not alone - laboratorians all over the world are doing the same. The solutions may lie in new approaches to risk management in the clinical lab. Risk Management Plans detail the methods put in place to manage and minimize the risk of a failure or mistake leading to reporting incorrect results. Some may choose a formalized process such as the one recommended by the Clinical Laboratory and Standards Institute while others may choose an approach that only looks at a key area of concern. This might be a focus on the analytical process that endeavors to assure that QC results are always evaluated before patient results are reported. Risk-based QC practices are of high interest around the globe. ISO guidelines now require risk of harm be part of the consideration when determining QC frequency. CLIA will soon allow QC frequency to be set based on a formal risk assessment. And many professional organizations and government agencies are reviewing risk management as a future option for their labs. Control procedures should conform to applicable regulatory and accreditation requirements. No matter your country or the organization that accredits your lab, don t leave your patients vulnerable with QC materials that are run at inappropriate intervals. Bio-Rad is committed to providing education about risk management practices. We have created a webpage that will be continually updated with articles and training opportunities. To obtain more information about regulations, guidelines and ideas about appropriate and effective Quality Control Plans for your laboratory, please visit us on the web at QCNet.com/patientrisk Visit myeinserts.com to view product inserts online, anytime. 7

11 Controls for Point of Care Testing The Leader in Quality Control Systems has a QC Solution for Your Point of Care Testing Bio-Rad quality controls are the most trusted controls in clinical laboratories worldwide, making them the ideal choice for use with your point of care instruments. Point of care testing (POCT) is rapidly growing in medical diagnostics due to its ease of use, fast turnaround time, and improving technology. It has become a tremendously valuable solution for quickly producing dependable test results at or near the site of patient care. POCT encompasses a wide range of testing platforms including small benchtop instruments, handheld devices, and dip stick tests. Similar to quality requirements for a central laboratory, independent third party controls are important to monitor the performance of your POCT instruments and to build confidence in your patient results. Bio-Rad quality control products are the ideal choice in POCT with their proven reliability demonstrated daily in thousands of central laboratories worldwide. In addition, Bio-Rad offers the most comprehensive QC data management solutions with a large peer to peer network, and assayed control values for many popular POCT instruments. 8 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

12 Controls for Point of Care Testing Controls for Popular Point of Care Instruments Bio-Rad offers a wide range of quality controls for use in various POCT settings. Look for the text "POCT Methods Listed" on the following pages to find the products that meet your POCT needs. Diabetes Urinalysis and Pregnancy Cardiac Assessment Chemistry Drugs of Abuse/Toxicology Blood Gas Refer to the table on pages for more information regarding Bio-Rad controls and POCT instruments, including Abbott, Alere, Beckman Coulter, Bio-Rad, Instrumentation Laboratory, Radiometer, Roche, Siemens, and others. quantify Plus Level I L Leukocytes neg. trace +/small ++/mod. +++/large Day of Month Example Unity Peer Group Report Enjoy the Benefits of Bio-Rad s Quality Control System in POCT Proven quality and reliability Consolidate with one QC vendor for the central lab and POCT Easy to use dropper bottles, or dropper tops available Convenient liquid formulations with no need for reconstitution for most products Efficiently manage and monitor QC data with Bio-Rad s Unity Program Affiliated Unity reports to compare multiple POCT instruments in multiple locations Easy to read peer group reports for urine dipstick testing International Standards Support the Value of QC in POCT As the number of point of care tests continue to grow, the need to minimize risk to the patient is becoming more critical. The international standards community has recognized this need and issued a standard for point of care testing, ISO In order to establish a well-designed quality management system, ISO states that, where available, internal QC and external quality assessment are required to be performed in the point of care setting. ISO is intended to be used in conjunction with ISO 15189, which specifies the requirements for quality and competence in the central laboratories. According to ISO 22870, the laboratory is responsible for the design, implementation, and operation of quality control that ensures POCT conforms to the quality standards of the central lab. Visit myeinserts.com to view product inserts online, anytime. 9

13 Controls for Popular Instruments Consolidate Your Quality Control with the Premier QC Portfolio from Bio-Rad Streamline your workflow by consolidating controls and simplifying management of your QC inventory. Regardless of the test methods used in your laboratory, Bio-Rad has an entire product line of multi-analyte quality controls that can help improve your laboratory's efficiency, and also help provide an unbiased assessment of system performance. By consolidating to fewer controls, you reduce the physical handling time of multiple vials and minimize the tracking of individual vial expirations; additionally, you reduce throwing out controls that are not used as often. By consolidating your QC needs with Bio-Rad, you can simplify your ordering and access our global technical and sales support network. Be sure to ask about our easy lot reservation and shipment options to minimize your QC inventory. Bio-Rad can meet all your QC needs through our line of quality controls covering the most comprehensive testing menus with Coagulation, Diabetes, Hematology, Blood Gas, Drugs of Abuse, Chemistry, Immunoassay, Cardiac, Tumor Markers, Immunology, Therapeutic Drug Monitoring and Infectious Disease. Ask how our Unity Interlaboratory Program can help you consolidate your QC data management solutions. See our Controls for Popular Instruments charts on pages for more information. One Bio-Rad Multi-Analyte Control Single Analyte Controls 10 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

14 My einserts Experience the Convenience of Electronic Inserts On-demand. Visit myeinserts.com Today. Don't spend another minute tracking down your data through printed inserts. My einserts is an online tool to view Bio-Rad quality control product inserts, at any time, through your Internet browser. Customize Your QC Inserts Find instruments and methods quickly Select analytes of interest Choose the preferred units to be displayed on your data charts Save Your Selections View, print or edit at any time Simply duplicate your selection to add a new lot of quality control product Receive Prompt Notifications Register to receive automatic notifications of data updates Only receive updates that apply to your selected instruments or methods Work Smarter & Easier Fast, easy Internet access to the most current QC values Available in over 25 languages Large font sizes for easy readability Environmentally friendly with less paper waste Visit myeinserts.com to view product inserts online, anytime. 11

15 Value Assignment Program Put Your Data to Work It May be More Valuable than You Think! Value Assignment participant laboratories earn money and help provide essential product insert data. Get Involved: Become a partner in product development and evaluation of new control lots while earning extra money for your laboratory. How? Through participation in Value Assignment or Product Development Studies for Bio-Rad quality control products. Get Rewarded: Payment amounts vary depending on the analyte(s) tested and number of data points required. Many laboratories use this as an opportunity to boost laboratory funds for education, training, instrument upgrades or employee appreciation.** If your laboratory has a local certification or accreditation from a nationally recognized body; you are invited to participate.* Enrollment forms along with additional program information can be found online. Contact us online for program specifics and we look forward to working with you. To learn more and become involved, visit QCNet.com/ProductStudies/ * For U.S. laboratories, the CLIA, JCAHO, CAP or COLA number is required. For other countries, local certification is acceptable. ** Please be advised that reimbursement for testing cannot be exchanged for product discount or pricing adjustment. 12 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

16 Quality Services Product Support Technical Services, QC Program and Software & Connectivity

17 Quality Services Product Support Product Support Support for Bio-Rad controls and software products does not end after you receive your products. Three support groups are available to help you with your questions and needs. By Phone within the U.S Monday Friday 5:00 AM to 5:00 PM Pacific Standard Time (PST) By Fax Technical Service When you purchase control products from Bio-Rad, you receive the backing of a full-service Technical Support Department. Bio-Rad Technical Service Representatives, many of whom are former laboratory managers and supervisors, are trained to handle your inquiries in a prompt, knowledgeable and professional manner. QC Program The QC Program Department at Bio-Rad offers you expert technical support and information for all Unity and EQAS technical support functions. Our QC Program staff answers inquiries about Unity software, QCNet enrollments, as well as EQAS enrollments, submission of data, cycle dates and EQAS eforms. Additional benefits are provided with continuing education seminar programs in Basic Statistics of Quality Control. This is a worldwide program and in the United States, P.A.C.E. accreditation may be obtained. Contact your local Bio-Rad office for more information on continuing education programs. Software and Connectivity Support The Software and Connectivity Support Department is dedicated to helping your laboratory get up and running with the latest QC data management and connectivity solutions from Bio-Rad. With the help of our experts, we ll make sure your laboratory is able to capture, analyze and submit QC data successfully. For Worldwide Customers For service outside the United States, please refer to the inside back cover of this catalog for the Bio-Rad location nearest you. 14 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

18 Quality Services Education Overview The Bio-Rad Path to Quality...17 Educational Resources on QCNet...18 Learning Tools

19 Quality Services Education Bio-Rad Offers the Educational Tools and Resources for Tomorrow s QC Experts We know you strive to deliver the most accurate test results possible and continuing education resources can help you stay current and aware of issues in Quality Control. That s why we developed our online education section: QCNet.com. Bio-Rad Laboratories has served clinical laboratories for over 35 years with a reputation for providing innovative quality control products and services. Our commitment to improving patient care has made us a leader in laboratory quality control. And because leadership has its responsibilities; we offer you even more. Even great products work best in skilled hands so Bio-Rad has committed to providing you with the educational tools to help you improve your ability to produce reliable test results. Whether you seek to begin with the fundamentals of QC theory; to continue building on the foundations of an existing program; or to develop advanced capabilities through leading-edge QC design, Bio-Rad has the educational tools and resources you need to succeed. Visit us at QCNet.com to learn more about our online educational library. You can view continuing education information and QC events along with an ever growing list of training materials in a variety of media something that fits your own learning style. 16 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

20 Quality Services Education Bio-Rad Path to Quality 1. Fundamentals Establish a strong foundation for basic laboratory quality practices Basic QC Theory Statistical Concepts EQA and PT Programs QC and Interlaboratory Programs 2. Practical Application Apply theoretical knowledge and introduce new practices Understanding Levey-Jennings Practical Use of Statistics QC Troubleshooting 3. Accreditation and Compliance Reach your accreditation and compliance goals; reinforce your commitment to Quality CLIA Compliance Accreditation Requirements, CAP, TJC, and COLA Seeking Laboratory Accreditation Under ISO Preparing for an Accreditation Audit 4. Advanced QC Tools Go beyond QC fundamentals and build on the informative power of statistical QC Interlaboratory Reports Meaningful QC Rule selection Quality Goals 5. Quality Expert! Advance Quality practices to the cutting edge using state-of-the-art QC theory and applications Statistical QC Design Theory Quality Indicators Traceability and Uncertainty Risk Based QC Planning Visit myeinserts.com to view product inserts online, anytime. 17

21 Quality Services Education Educational Resources Available on QCNet Visit QCNet.com for updates and new programs, or contact your Bio-Rad sales representative for more information. Bio-Rad continues to develop a growing library of educational materials, online learning courses, interactive customer training, practical QC workshops, small and large group continuing education seminars, innovative job aids, and unique collaboration opportunities for laboratories that are committed to achieving a higher standard of patient care. Bio-Rad Learning Tools Series Contact your local Bio-Rad sales representative for more information about these and other new publications. Basic Lessons in Laboratory Quality Control Illustrates how to set-up a simple and effective QC system using statistical process control. Seeking Laboratory Accreditation Under ISO Provides a general overview of ISO 15189, each Quality System Essential and the framework of constructing a laboratory quality system. Basic & Intermediate Quality Control Systems Introduces basic quality control and statistics used in the clinical laboratory in a clear and easy-to-read format. Building an Effective Laboratory QC System Assists in developing an internal QC system to meet basic requirements for quantitative tests. Using Quality Control Explains the importance of using QC in your laboratory, implementing a quality system, and how QC data can help improve your laboratory's test results. Unity Interlaboratory Program A complete guide to optimizing the performance of the quality system in your laboratory using an effective peer comparison program. Producing Reliable Test Results in the Medical Laboratory Uses a quality system approach and ISO to assure the quality of laboratory examination procedures. Discover the Importance of Third Party Quality Control Explains the importance of an unbiased assessment when monitoring the performance of laboratory testing instruments and procedures. QC Troubleshooting Poster A troubleshooting schematic to place on the wall of your laboratory that provides entry-level QC guidance. 18 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

22 QC Data Management Solutions QC Data Management Services Unity Interlaboratory Program Overview Unity Interlaboratory Program Reports Software Solutions Unity Software Comparison Chart Unity Real Time UnityWeb Unity Real Time LT Westgard Advisor Unity Alert Connectivity Solutions UnityConnect WebConnect Online and Mobile Services QCNet QCNet.Mobi

23 QC Data Management Solutions The Unity Interlaboratory Program: Powerful Effective Trusted Worldwide Join over 19,000 of your peers and benefit from data generated by users around the world. Using our comprehensive product line of third party controls is an important step toward helping you improve the reliability of your laboratory results. The ability to successfully manage and interpret your quality control results is also essential to producing solid, dependable laboratory outcomes. Bio-Rad Laboratories offers a vision and a commitment to quality control that is unsurpassed in the clinical laboratory industry. Today your laboratory can be connected to the Unity Interlaboratory Program, the world s largest community of quality control users. Improve patient care and cost effectiveness with quality control products, quality control data management solutions, industry-leading interlaboratory comparisons and personalized service from Bio-Rad. Benefit from peer QC data generated from more than 38,000 instruments in 92 countries Help to detect and identify potentially important analytical errors Meet accreditation and regulatory requirements Increase confidence in proficiency survey outcomes Help to identify unrecognized trends or shifts that may occur between proficiency surveys Receive on-demand interlaboratory comparison reports Receive monthly reports with regular data submissions for routine review Submit data in real time using one of our Unity software solutions 20 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

24 QC Data Management Solutions Basic Advanced Desktop based Web based Flexible, Custom Solutions Available to Fit Your Needs The value of our Unity Interlaboratory Program resides in the peer group data, statistical programs and the quality control reports. Program participation is available to customers through a choice of options; different solutions designed to accommodate your specific needs. As you view the following pages, refer to the small graphics to determine whether you are examining a program with connectivity via online access or desktop software and whether the program provides basic or advanced user options. Please turn to the following pages to see example reports and a chart with detailed specifics about the interlaboratory solution best suited to your laboratory. The Advantages of Participating in the Unity Interlaboratory Program Detecting Errors in Your Test System Without a high quality interlaboratory program, your laboratory may not be aware of gradual or sudden changes in your test system that may be caused by events such as reagent or calibrator reformulations, standardization changes, or instrument software changes. An interlaboratory program can offer early awareness of shifts and trends to help avoid costly test repeats and unnecessary troubleshooting. Improving Outcomes on Proficiency Surveys An interlaboratory program can also increase your confidence in proficiency surveys. If your laboratory compares well to other laboratories in an interlaboratory program, you are also likely to compare well to other laboratories participating in your proficiency testing program. Your Proficiency Program is Not Enough Proficiency surveys are only a snapshot of performance; they cannot detect ongoing data trends and should not be used as a substitute for daily quality control in conjunction with an interlaboratory program. Acceptable performance on the day of the proficiency testing does not guarantee testing reliability every day. Statistically Relevant Peer Data Monthly Unity Interlaboratory Reports ensure that peer group sizes are maximized for regular, periodic review of your test systems. These reports are comprehensive and represent the largest peer groups in the industry. Are Laboratories Required to Participate in an Interlaboratory Program? The laboratory shall participate in interlaboratory comparisons... ISO 15189:2007(E), Subclause The laboratory shall design internal quality control systems that verify the attainment of the intended quality of results. It is important that the control system provide staff members with clear and easily understood information on which to base technical and medical decisions... ISO 15189:2007(E), Subclause For laboratory self-evaluation, peer-related bias and relative imprecision are useful parameters. Participation in an interlaboratory program provides an effective mechanism to complement external quality assessment (proficiency surveys) programs. Consequently, a laboratory should actively participate in interlaboratory QC programs when such programs are available. CLSI (formerly NCCLS), C24-A3, Vol. 26, No 25. Visit myeinserts.com to view product inserts online, anytime. 21

25 QC Data Management Solutions The Most Comprehensive Peer Reports for Managing Your Quality System The following reports are available to your laboratory when you participate in the Unity Interlaboratory Program. You already know the benefits of participation in an interlaboratory program comparison of your performance to peer group data and the opportunity to detect trends or shifts before they become problematic. It s easy with access to instant as well as monthly reports, Westgard Rules, a variety of charts and a selection of optional reports. Whether you seek to troubleshoot a known issue or simply want to assess your laboratory's bias and imprecision the Unity Interlaboratory reports on these pages demonstrate how quickly and intuitively you can find the answers. Laboratory Comparison Report The Laboratory Comparison Report allows you to compare your results to those of your peer and method consensus groups. This report includes many vital statistics and is often the first report reviewed by Unity participants. Lab Laboratory Comparison Report Multiqual 1, 2, 3 Unassayed Lot Statistics for Each Test Monthly Cumulative QC Coordinator Associated Regional Laboratory 123 Main Street Anytown, NY, Analyte Methods Units Temp Intrument / Kit Reagent Alkaline Phosphatase PNPP, AMP Buffer U/L 37 C Level 1 Mon Cum Data For: Lot Exp: Printed: Page 1 Level 2 Level 3 Mon Cum Mon Cum Your Lab Mean SD CV (Peer) CVR (Method) CVR (Peer) SDI (Method) SDI # Points Roche MODULAR Dedicated Reagent ean Your Lab Mean SD CV (Peer) CVR (Method) CVR (Peer) SDI (Method) SDI # Points Each test will contain Peer & Method Group Statistics nt Monthly Cumulative Peer Group Roche MODULAR Group Values by Method Mean SD CV # Points # Labs Mean SD CV # Points # Labs Peer Group Roche MODULAR Group Values by Method Mean SD CV # Points # Labs Mean SD CV # Points # Labs Each test will contain 22 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

26 QC Data Management Solutions Bias & Imprecision Histogram Report This report provides a graphic representation of your laboratory s bias compared to the current cumulative peer group mean and your CV. On the chart, your monthly CV is represented as a bar, and your bias is represented as a diamond with lines connecting each diamond. Lab Bias & Imprecision Histogram Unassayed Chemistry Lot QC Coordinator Associated Regional Laboratory 123 Main Street Anytown, NY, Data For: Lot Exp: Printed: Page 1 Acetaminophen Enzymatic, colorimetric Level 1 CV Bias Siemens ADVIA 1650 DCL µg/ml (%) Oct12 Nov12 Dec12 Jan13 Feb13 Mar13 Apr13 May13 Jun13 Jul13 Aug13 Sep13 CV Bias Affiliated Reports (Optional) Affiliated reports are designed for quick review and focus on key statistics to provide a performance summary of each participating affiliated laboratory in a single report. Affiliated Laboratory Comparison Report Lab Unassayed Chemistry QC Coordinator Associated Regional Laboratory 123 Main Street Anytown, NY, Lot Data For: Lot Exp: Printed: Page 1 Analyte Methods Units Temp Intrument / Kit Reagent Lab Mon Level 1 Cum Mon Level 2 Cum Glucose Glucose oxidase, hydrogen peroxide (Trinder) VITROS 250 / 500 / 700 Slide Generation #32 mg/dl Associated Regional Laboratory Mean SD CV # Points Lab to Peer Group Lab to Lab Group CVR SDI CVR SDI Visit myeinserts.com to view product inserts online, anytime. 23

27 QC Data Management Solutions Additional Reports Available Monthly Evaluation Report The Monthly Evaluation Report provides a quick overview of laboratory performance for the month. This report alerts you when your SDI or CVR exceeds threshold limits. Data Rejection Report The Data Rejection Report identifies data that has been excluded from the Unity Interlaboratory Program. Laboratory Performance Overview Report The Laboratory Performance Overview Report allows you to visually evaluate both your bias and imprecision for each of your tests compared to the peer and method consensus groups on a modified Youden Chart. Laboratory Histogram Report The Laboratory Histogram Report contains information that you report for each analyte over a 12-month period. You can use this report to visually compare your performance to your peer group over time, and it is useful for identifying both shifts and trends in your monthly results. Worldwide Report (Optional) The Worldwide Report summarizes all data submitted to the Unity Interlaboratory Program and demonstrates both the tremendous breadth of the program and the size of the consensus groups. Statistical Profile Report (Optional) The Statistical Profile Report allows you to compare your laboratory s statistics to the peer, method, and all laboratories consensus groups. InstantQC Reports (Optional) InstantQC Reports are generated at the moment you request a report with all the peer data that is available at the moment the report is requested. Urinalysis Reports (Optional) If you submit data for any Bio-Rad Urinalysis Control product to the Unity Interlaboratory Program, you will receive a report that includes a Chemistry Report for each method submitted (when appropriate) and a Microscopics Report for each method submitted (when appropriate). Receive On-Demand InstantQC Reports via QCNet Today! InstantQC Reports permit you to compare your control results to other laboratories at any time. These on-demand reports are particularly useful for troubleshooting problems with test system performance. 24 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

28 QC Data Management Solutions There s a Unity Interlaboratory Solution Designed to Suit Your Needs Bio-Rad Laboratories offers several options for participation in the Unity Interlaboratory Program. Refer to the product comparison grid below to help determine which solution is the most appropriate for your laboratory. Internet-based solutions such as UnityWeb and Unity Real Time online eliminate the need to install and update software locally in your laboratory, and reduce the amount of support necessary from on-site IT staff. Desktop software solutions, like Unity Real Time, are appropriate if your internet connection is not sufficient, or if you prefer maintaining local software. Basic User Options Advanced User Options UnityWeb Unity Real Time Unity Real Time LT online Unity Real Time Type of Solution Web Service (Internet-Based) X X Desktop Software X X Unity Interlaboratory Reports Monthly Reports X X X X InstantQC Reports X X X X Basic Intralaboratory Charts & Reports Westgard Rules X X X X Various Charts and Reports X X X X Additional Features Westgard Advisor (Subscription sold separately) X X X Bench Review X X X X Bench & Supervisor Data Review X X Analytical Goals X X Dynamic Data Set Comparisons X X Database Platform Bio-Rad Hosted X X Installed on Local Laboratory PC X X Connectivity (Sold separately) WebConnect X X UnityConnect X X X X Want to know more? Discover the power of Unity Solutions at Visit myeinserts.com to view product inserts online, anytime. 25

29 QC Data Management Solutions Unity Real Time Expert QC Data Management Solution for Desktop or Online Users Facilitates regulatory compliance under CLIA and ISO Improves real-time bench and supervisor QC data review Implements best QC rules when used with Westgard Advisor Runs validation with comprehensive audit trails Provides advanced charts and reports for data analysis Reduces non-essential retests with Analytical Goal options Uploads QC data points from an LIS, middleware or instrument (optional) RiLiBÄK Advisor module available to comply with German regulations Unity Real Time Routine QC data review is streamlined for bench-level technologists and lab supervisors with the Bench and Supervisor Review features. Evaluate specific trends or shifts using Levey-Jennings charts and other advanced charting options. Unity Real Time online Comprehensive data entry screens provide a complete audit trail of lot-to-date performance. The patented Data Analysis Grid facilitates the comparison of user-selected QC data sets, such as two instruments running the same set of tests. 26 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

30 QC Data Management Solutions UnityWeb Entry-Level Online QC Data Management Solution No software to install and maintain Basic QC rules, charts and reports Easily upgradable to Unity Real Time online for more advanced tools and features Upload QC data points from an LIS, middleware or instrument (optional) Enter QC data efficiently for interlaboratory comparison using the multi-test data entry screens. Conveniently manage the configuration of control lots and tests. Unity Real Time LT Entry-Level Desktop QC Data Management Solution Basic QC rules, charts and reports Configurable Levey-Jennings charts Easily upgradable to Unity Real Time for more advanced tools and features Upload QC data points from an LIS, middleware or instrument (optional) Easily detect trends or shifts with configurable Levey-Jennings charts. Set up Westgard rules to evaluate each data point. Visit myeinserts.com to view product inserts online, anytime. 27

31 QC Data Management Solutions Additional Unity Program Options: When the Details are Really Important When you demand more from your quality control program... Westgard Advisor Automatic QC Rules Selection Engine Recommend and automatically apply best QC rules with patented technology Easy step-by-step automatic rule selection capabilities Reduce false rejections and desensitization to false error flags Save time and money by reducing unnecessary repeats and troubleshooting Improve laboratory test quality with optimally selected QC rules Available as an optional module with Unity QC data management solutions Unity Alert Continuosly Monitor QC Status Notifications of missing QC runs can help to ensure proper monitoring of instrument performance Notifications of new violations can be useful for troubleshooting and monitoring problem analytes Setting up alert rules is easy and flexible and can be set up for specific instruments or tests Lab supervisors and managers can receive s remotely to stay informed regarding QC issues in the laboratory even while they are out of the office The color-coded displays are helpful to draw attention to the most urgent QC issues Notifications are provided even when Unity Real Time is not in use Available as an optional module with Unity Real Time 28 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

32 QC Data Management Solutions Connectivity Solutions for Automated Uploads to Unity Software Simple automated uploading of your data from your instruments, middleware and LIS to Unity Software solutions. Unlock powerful functionality in Unity with real-time connectivity. We adapt to your environment with online and locally installed solutions to capture data directly from instruments, middleware or LIS. Auto-verification support available with popular middleware solutions. Personalized, Step-by-step Deployment Bio-Rad connectivity experts work directly with your IT team Our Training Department provides a wealth of curriculum and personalized training sessions for your lab personnel You set the pace; we work to your timetable Middleware LIS Reliability Based on Experience We connect more than a thousand customers per year to Unity Pre-existing solutions for hundreds of devices to get you up and running quickly Enterprise solutions can connect multiple sites across continents Connectivity Unity Instrument UnityConnect A connectivity solution that allows QC data from LIS systems, middleware and/or instruments to be quickly and easily imported into Unity software and web services. Eliminates manual keying of QC data Enables standard LIS QC reports to be used Provides automatic data import Provides real-time connection Transparent to the flow of data to the LIS Captures and analyzes QC data economically from laboratory instruments not connected to the LIS Easy-to-install optional interface hardware Choose from soft, serial, ethernet and wireless connections WebConnect A web-based connectivity solution that allows laboratories to easily upload QC data from LIS systems, middleware and/or instruments directly into Unity Real Time online or UnityWeb. Eliminates manual keying of data Enables standard LIS QC reports to be used No software to install Visit myeinserts.com to view product inserts online, anytime. 29

33 QC Data Management Solutions QCNet The Leading QC Portal on the Internet Learn more about the many QC tools and resources from Bio-Rad at Unity Interlaboratory Reports Access your monthly Unity and InstantQC Reports in just a few quick clicks Local QCNet Visit your local QCNet portal, which will provide specific information related to your country (where available) Additional Online QC Tools Access to EQAS services Linearity Web einserts XML Product Inserts (My einserts ) Barcode Label Generator Urinalysis Tools QCNet University MSDS Code Lists for Unity Enjoy QC on the Move with QCNet.mobi Access Unity, EQAS, My einserts and more from your smart phone or other mobile device. Bio-Rad's industry-leading software programs are now available to you from any location, at your convenience. Scan the QR code below to access QCNet.mobi, your portal to our online mobile services. EQAS Mobile Participate in Bio-Rad's External Quality Assurance Services programs from the palm of your hand. Quickly view your EQAS reports and assess your laboratory's performance against your peers Internationally recognized EQAS provider, accredited to ISO My einserts Mobile Instantly view the latest QC product insert values customized to your instruments and analyte selections. Sign up for e-notification of updates Unity Mobile Join the world's most comprehensive interlaboratory program from your smart phone Improve the analytical performance of your laboratory Easy data submission and reporting Access peer group data from over 19,000 labs and 38,000 instruments QC Product Information Link to for information about more than 300 QC products offering over 600 analytes Scan to access Optimized for minimum data plan usage 30 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

34 External Quality Assurance Services (EQAS ) About Bio-Rad EQAS EQAS Program Overview Online EQAS Resources Submitting Results EQAS Reports EQAS Programs Clinical Chemistry (Monthly) Program Urine Chemistry Program Immunoassay (Monthly) Program Therapeutic Drug Monitoring Program Serum Proteins Program Tumor Marker Program Hemoglobin Program Hematology Program Blood Gas Program Cardiac Markers Program Coagulation Program Ethanol/Ammonia Program Lipids Program See the EQAS Analyte Chart on pages

35 External Quality Assurance Services (EQAS ) Participate in an Internationally Recognized Quality Assessment Program Bio-Rad EQAS programs are fully accredited to help meet the regulatory needs of today's clinical laboratories. External quality assessment programs are accepted around the world as invaluable tools used by laboratories to periodically assess the performance of their test systems. Results are objectively compared to other laboratories using the same methodologies, instruments and reagents. When used in conjunction with daily quality controls, these external programs can give laboratories added confidence in reporting their patient test results. As the worldwide leader in the development of quality control systems, participants in EQAS can benefit from the experience, knowledge and reliability that Bio-Rad has offered for more than 35 years. Bio-Rad EQAS programs provide an independent and confidential external assessment of individual laboratory performance. Large international database with participants from over 100 countries Accredited to ISO/IEC 17043:2010 "Conformity assessment General requirements for proficiency testing" Comprehensive, easy-to-read reports Technical support from experienced professionals Three convenient electronic reporting options to choose from (EQAS Online, EQAS Mobile and eforms 2 software) Each cycle includes 12 high quality samples together in one convenient shipment (except Hematology Program) Extensive and flexible analyte menus offer cost-effective choices Analyte levels that challenge both normal and abnormal ranges An environmentally friendly option 32 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

36 External Quality Assurance Services (EQAS ) EQAS Program Overview Contact your Bio-Rad Representative to place your order and receive a unique laboratory number Register your test methods Getting Started Select and enroll in your desired EQAS programs Configure your lab information and register tests electronically via software, online or smart phone (If submitting results on paper, return completed Method Registration Forms to Bio-Rad. Cycle-specific Results Forms will then be mailed to you) Receive specimen package containing all twelve samples for a specific cycle (Hematology samples are provided in multiple shipments of three samples each) Specimen Package is shipped to you Testing Samples and Submitting Data Each EQAS sample is uniquely numbered for easy identification Submit results on time using one of the preferred electronic methods of reporting Sample due dates are provided in a number of places including the sample label, product inserts, EQAS Calendar and Submission Calendar on QCNet.com Reviewing Reports and Troubleshooting Securely access your laboratory specific sample report online within three days of the statistical analysis (Paper copies may be requested) A Certificate of Registration will accompany your Sample 1 Report For help interpreting your EQAS reports, view the tutorial on QCNet.com, or seek assistance from your knowledgeable Bio-Rad representative Test the appropriate EQAS sample as a patient sample Submit your results in a timely manner Receive your confidential Sample Report Implement corrective measures based on laboratory performance Continue process for entire program cycle Receive an End-of-Cycle Report Earn a Certificate of Achievement Program Cycle Completion The End-of-Cycle Report provides an overall assessment of your laboratory s performance in terms of bias A Certificate of Achievement is issued to you if a minimum amount of acceptable data has been submitted for the cycle Visit myeinserts.com to view product inserts online, anytime. 33

37 External Quality Assurance Services (EQAS ) Online EQAS Resources Access product information, product inserts and user documentation through This secure website allows registered participants access to training material, customer notifications and provides the ability to submit results with EQAS Online, upload eforms data files, and view or print EQAS reports. Become a Registered QCNet User Go to today and click on the Log In/Register link. Once you've completed the new user form, you will have access to all available EQAS tools. Register your EQAS Lab Number 1. Log in to 2. Click the EQAS tab 3. Click on EQAS Registration 4. Enter your EQAS lab number and select your country 5. Click Register, and you are done Please allow up to 2 business days to process your registration. Upon verification, your EQAS reports will be posted. Submitting Results Bio-Rad offers 3 methods for submitting results: EQAS Online Conveniently manage your laboratory's test configuration and submit results from any device with an internet connection. eforms 2 Software Transmit your test configuration and results with this easy-to-use software. Paper Forms Submit your results via to EQAS@bio-rad.com, or by fax or postal service. EQAS Reports Participants receive twelve sample reports and one end-of-cycle report over each program cycle. These detailed reports are presented in an easy-to-read graphic format. Sample reports are available online within three days of the statistical analysis. Additional special reports (Subgroup and Instrument/Method Summary) are available to registered participants. Sample Report Detailed individual statistical analyses and peer group comparisons are provided. End-of-Cycle Report An overall assessment of laboratory performance over the entire cycle in terms of bias among participating laboratories is presented. 34 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

38 External Quality Assurance Services (EQAS ) Clinical Chemistry (Monthly) Program Lyophilized, human serum based Choice of program size to suit your needs 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Acid Phosphatase (Total) Alanine Aminotransferase (ALT/SGPT) Albumin Alkaline Phosphatase (ALP) Amylase (Pancreatic) Amylase (Total) Aspartate Aminotransferase (AST/SGOT) Bilirubin (Direct) Bilirubin (Total) Calcium (Ionized) Refer to the package insert for current analyte claims. Calcium (Total) Carbon Dioxide (CO 2) Chloride Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Copper Cortisol Creatine Kinase (CK) Creatinine Gamma Glutamyl Transferase (GGT) Glucose Iron Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsaturated (UIBC) Lactate Lactate Dehydrogenase (LDH) Lipase Lithium Magnesium Osmolality Phosphate Potassium Protein (Total) Sodium Thyroid Stimulating Hormone (TSH) Thyroxine (T4), Total Triglycerides Triiodothyronine (T3), Total Urea Urea Nitrogen Uric Acid Zinc Pilot Thyroxine, Free (FT 4 ) Triiodothyronine, Free (FT 3 ) Cat # EQAS Program Qty Cat # *Select analytes from comprehensive menu above. Qty BC5L BC50 CS5L Clinical Chemistry (Monthly) Program (10 )* x 5 ml Clinical Chemistry (Monthly) Program (43 ) x 5 ml Clinical Chemistry (Monthly) Program (10 )*...Report only CS50 QC50 Clinical Chemistry (Monthly) Program (43 )....Report only Clinical Chemistry (Monthly) Program (specimen pack only) x 5 ml Urine Chemistry Program Lyophilized, human urine based Matrix appropriate samples include basic and specialty urine chemistry analytes Choice of program size to suit your needs 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at 5-Hydroxyindoleacetic Acid (5-HIAA) Aldosterone Calcium (Total) Chloride Cortisol (Free) Refer to the package insert for current analyte claims. Creatinine Dopamine Epinephrine Glucose Homovanillic Acid (HVA) Hydroxyproline (Total) Magnesium Metanephrine Microalbumin Norepinephrine Normetanephrine Osmolality Phosphorus Potassium Protein (Total) Sodium Urea Nitrogen Uric Acid Vanillylmandelic Acid (VMA) Cat # EQAS Program Qty Cat # *Select analytes from comprehensive menu above. Qty BC40 BC45 CS40 Urine Chemistry Program (12 analytes)* x 10 ml Urine Chemistry Program (24 analytes) x 10 ml Urine Chemistry Program (12 analytes)*....report only CS45 QC40 Urine Chemistry Program (24 analytes)....report only Urine Chemistry Program (specimen pack only) x 10 ml Visit myeinserts.com to view product inserts online, anytime. 35

39 External Quality Assurance Services (EQAS ) Immunoassay (Monthly) Program Lyophilized, human serum based Comprehensive menu of the most commonly tested immunoassay analytes Choice of program size to suit your needs 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at 17-α-OH-Progesterone 25-OH Vitamin D β-2 Microglobulin ACE ACTH Aldosterone Alphafetoprotein (AFP) C-Peptide CA 125 CA 15-3 CA 19-9 Calcitonin Carbamazepine Carcinoembryonic Antigen (CEA) Cortisol DHEA Sulfate Digoxin Estradiol Estriol, Free (UE 3) Ferritin Folate Follicle Stimulating Hormone (FSH) Gastrin hcg hgh Immunoglobulin E (IgE) Insulin Intact PTH LH Phenobarbital Phenytoin Plasma Renin Activity Progesterone Prolactin PSA (Free) PSA (Total) Renin Sex Hormone Binding Globulin (SHBG) T3 Uptake T-Uptake Testosterone Theophylline Thyroid Stimulating Hormone (TSH) Thyroxine, Free (FT4) Thyroxine (T4), Total Thyroxine Binding Globulin (TBG) Transferrin Triiodothyronine, Free (FT3) Triiodothyronine (T3), Total Valproic Acid Vitamin B 12 Refer to the package insert for current analyte claims. Cat # EQAS Program Qty Cat # *Select analytes from comprehensive menu above. Qty BC7L BC70 BC75 CS7L Immunoassay (Monthly) Program (8 analytes)* x 5 ml Immunoassay (Monthly) Program (17 analytes)* x 5 ml Immunoassay (Monthly) Program (51 analytes) x 5 ml Immunoassay (Monthly) Program (8 analytes)*....report only CS70 CS75 QC75 Immunoassay (Monthly) Program (17 analytes)*....report only Immunoassay (Monthly) Program (51 analytes)...report only Immunoassay (Monthly) Program (specimen pack only).. 12 x 5 ml Therapeutic Drug Monitoring Program Lyophilized, human plasma based Choice of program size to suit your needs targeted at therapeutic, sub-therapeutic and toxic levels 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Acetaminophen Amikacin Amitriptyline Caffeine Carbamazepine Cyclosporine Digoxin Ethosuximide Gentamicin Lithium Methotrexate Nortriptyline Phenobarbital Phenytoin Primidone Salicylate Theophylline Tobramycin Tricyclic Antidepressants (TCA) Screen Valproic Acid Vancomycin Refer to the package insert for current analyte claims. Cat # EQAS Program Qty Cat # *Select analytes from comprehensive menu above. Qty BC05 BC10 CS05 TDM Program (12 analytes)* x 5 ml TDM Program (21 analytes) x 5 ml TDM Program (12 analytes)*....report only CS10 TDM Program (21 analytes)....report only QC05 TDM Program (specimen pack only) x 5 ml 36 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

40 External Quality Assurance Services (EQAS ) Serum Proteins Program Lyophilized, human serum based Comprehensive menu for monitoring serum protein assays 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at α-1 Acid Glycoprotein α-1 Antitrypsin β-2 Macroglobulin β-2 Microglobulin Albumin Antistreptolysin O (ASO) C-Reactive Protein (CRP) Refer to the package insert for current analyte claims. Ceruloplasmin Complement C3 Complement C4 Haptoglobin Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Kappa Light Chain (Total) Lambda Light Chain (Total) Prealbumin Protein (Total) Rheumatoid Factor (RF) Transferrin Cat # EQAS Program Quantity BC23 CS23 QC23 Serum Proteins Program x 1 ml Serum Proteins Program....Report only Serum Proteins Program (specimen pack only) x 1 ml Tumor Marker Program Lyophilized, human serum based Comprehensive list of analytes at normal and abnormal levels 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at ACTH Alphafetoprotein (AFP) CA 125 CA 15-3 CA 19-9 Refer to the package insert for current analyte claims. CA Carcinoembryonic Antigen (CEA) hcg NSE PSA (Free) PSA (Free/Total Ratio) PSA (Total) S100 Protein Cat # EQAS Program Quantity BC24 CS24 QC24 Tumor Marker Program x 1 ml Tumor Marker Program....Report only Tumor Marker Program (specimen pack only) x 1 ml Visit myeinserts.com to view product inserts online, anytime. 37

41 External Quality Assurance Services (EQAS ) Hemoglobin Program Lyophilized, human whole blood based Includes HbA1C and HbA 2 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Hemoglobin (Total Glycated) Hemoglobin A1C Hemoglobin A 2 Refer to the package insert for current analyte claims. Cat # EQAS Program Quantity BC80 CS80 QC80 Hemoglobin Program x 0.5 ml Hemoglobin Program....Report only Hemoglobin Program (specimen pack only) x 0.5 ml Hematology Program Liquid product with human RBCs Choice of 11 basic hematology parameters For use on manual or automated analyzers Convenience of primary pierceable tubes 12-month cycle consisting of 4 separate shipments Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Hematocrit (HCT) Hemoglobin Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Refer to the package insert for current parameter claims. Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) Platelets (PLT) Red Blood Cell Distribution Width (RDW) Red Blood Cell Distribution Width (RDW-SD) Red Blood Cells (RBC) White Blood Cells (WBC) Cat # EQAS Program Qty Cat # Qty BC90A Hematology Program, Shipment A... 3 x 2 ml BC90B Hematology Program, Shipment B x 2 ml BC90C Hematology Program, Shipment C x 2 ml BC90D Hematology Program, Shipment D x 2 ml CS90 Hematology Program....Report only QC90A Hematology Program, Shipment A (specimen pack only) x 2 ml QC90B Hematology Program, Shipment B (specimen pack only) x 2 ml QC90C Hematology Program, Shipment C (specimen pack only) x 2 ml QC90D Hematology Program, Shipment D (specimen pack only) x 2 ml 38 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

42 External Quality Assurance Services (EQAS ) Blood Gas Program Liquid, aqueous samples Comprehensive menu for monitoring performance of Blood Gas, Electrolytes, Glucose, Lactate and Magnesium 12-month cycle Choice of program size to suit your needs Option to submit data electronically and view reports online at Calcium (Ionized) Chloride Glucose Lactate (Lactic Acid) Magnesium ph pco 2 po 2 Potassium Sodium Refer to the package insert for current analyte claims. *Select analytes from comprehensive menu above. Cat # EQAS Program Quantity BC30 BC31 CS30 CS31 QC31 Blood Gas Program (3 analytes)*...12 x 2.5 ml Blood Gas Program (10 analytes) x 2.5 ml Blood Gas Program (3 analytes)*...report only Blood Gas Program (10 analytes)....report only Blood Gas Program (specimen pack only) x 2.5 ml Cardiac Markers Program Liquid, human plasma based Comprehensive menu of important cardiac assessment markers, plus D-dimer 12-month cycle Choice of program size to suit your needs Option to submit data electronically and view reports online at BNP CK-MB Mass D-dimer hs-crp Myoglobin NT-ProBNP Troponin I Troponin T Refer to the package insert for current analyte claims. *Select analytes from comprehensive menu above. Cat # EQAS Program Quantity BC38 BC39 CS38 CS39 QC39 Cardiac Markers Program (5 analytes)* x 1.5 ml Cardiac Markers Program (8 analytes) x 1.5 ml Cardiac Markers Program (5 analytes)*....report only Cardiac Markers Program (8 analytes)....report only Cardiac Markers Program (specimen pack only) x 1.5 ml Coagulation Program Lyophilized, human plasma based 8 basic parameters for monitoring coagulation disorders such as hemorrhage and thrombosis 12-month cycle Choice of program size to suit your needs Option to submit data electronically and view reports online at APTT Antithrombin III (ATIII) Fibrinogen INR Protein C Activity Protein S Activity PT Thrombin Time (TT) Refer to the package insert for current analyte claims. Cat # EQAS Program Qty Cat # *Select analytes from comprehensive menu above. Qty BC33 BC34 Coagulation Program (4 analytes)* x 1.0 ml Coagulation Program (8 analytes)...12 x 1.0 ml CS33 CS34 QC34 Coagulation Program (4 analytes)*....report only Coagulation Program (8 analytes)...report only Coagulation Program (specimen pack only)* x 1.0 ml Visit myeinserts.com to view product inserts online, anytime. 39

43 External Quality Assurance Services (EQAS ) Ethanol/Ammonia Program Liquid, human serum based Clinically relevant levels of serum Ethanol and Ammonia 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Ammonia Ethanol Refer to the package insert for current analyte claims. Cat # EQAS Program Quantity BC35 CS35 QC35 Ethanol/Ammonia Program x 3.0 ml Ethanol/Ammonia Program....Report only Ethanol/Ammonia Program (specimen pack only)...12 x 3.0 ml Lipids Program Liquid, human serum based Comprehensive menu of lipid profile analytes 12-month cycle Submit results for the appropriate sample every month Option to submit data electronically and view reports online at Apo-A1 Apo-B Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Triglycerides Pilot Analyte Lipoprotein (a) Refer to the package insert for current analyte claims. *Select analytes from comprehensive menu above. Cat # EQAS Program Quantity BC46 BC47 CS46 CS47 QC47 Lipids Program (3 analytes)* x 3.0 ml Lipids Program (6 analytes) x 3.0 ml Lipids Program (3 analytes)*....report only Lipids Program (6 analytes)....report only Lipids Program (specimen pack only) x 3.0 ml 40 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

44 Immunoassay Controls Liquichek Immunoassay Plus Control Lyphochek Immunoassay Plus Control Liquichek Specialty Immunoassay Control Lyphochek Anemia Control Liquichek Tumor Marker Control Lyphochek Tumor Marker Plus Control Lyphochek Maternal Serum Control Lyphochek Fertility Control Lyphochek Hypertension Markers Control Lyphochek Endocrine Control Lyphochek Urine Bone Markers Control See pages for information about our EQAS Programs. See page 124 for helpful product accessories. 41

45 Immunoassay Controls Bio-Rad Immunoassay Controls Offer Over 200, From the Routine to the Esoteric. Many of Bio-Rad's multi-analyte immunoassay controls offer analyte target values designed to fall at or near significant clinical decision points. Immunoassays play a prominent role in the detection and diagnosis of many disease states. When treatment is based on benchmarking against clinical decision levels, having control results close to that value helps laboratories feel more confident in reporting those patient results. For that reason, many Bio-Rad multi-analyte immunoassay controls have analyte target values designed to fall at or near clinical decision levels. A leader in quality control products and services, Bio-Rad provides effective quality control solutions through our extensive range of multi-analyte controls with value assignments for hundreds of immunoassay methods. Bio-Rad immunoassay controls offer more than 200 routine and esoteric analytes. Your technologists can count on Bio-Rad's quality control products and Unity Interlaboratory Program to increase your confidence in system and assay performance. 42 To order in the United States, call

46 Immunoassay Controls Liquichek Immunoassay Plus Control A liquid control designed for convenience in today s busy immunoassay laboratory. With a comprehensive analyte menu, this human serum based control can replace two or more separate control products for immunoassay and therapeutic drug monitoring QC testing. 5 ml Fill Size Comprehensive IA and TDM control Assayed values available for most automated immunoassay analyzers 2 year shelf life at -20ºC to -70ºC 14 day open-vial stability at 2-8ºC for most analytes 2.5 ml Fill Size Offers more than 40 analytes for the Dimension Vista immunoassay test menu 2 year shelf life at -20ºC to -50ºC 4 day unopened (unpunctured) stability when stored refrigerated at 2-8ºC 4 day open-vial (punctured) stability for all analytes when stored at 2-8ºC POCT Methods Listed 11-Deoxycortisol* 1 17-α-Hydroxyprogesterone 1 25-Hydroxy Vitamin D* 1 Acetaminophen Aldosterone 1 Alphafetoprotein (AFP) Amikacin Amiodarone* 1 Amitriptyline* 1 Androstenedione 1 Angiotensin I* 1 Anti-Thyroglobulin (Anti-Tg)* 1 Anti-Thyroperoxidase (Anti-TPO)* 1 Caffeine Carbamazepine Carbamazepine (Free) 1 CEA Chloramphenicol 1 CK-MB Isoenzyme Cortisol 1 Cyclosporine 1 Desipramine 1 DHEA* 1 DHEA Sulfate 1 Digoxin Disopyramide 1 Estradiol Estriol (Free) 1 Estriol (Total)* 1 Estrogen (Total) 1 Ethosuximide 1 Ferritin Flecainide 1 Folate Fructosamine 1 FSH Gentamicin hcg 1 hcg-β Subunit hgh 1 Ibuprofen 1 Imipramine* 1 Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Insulin 1 Iron *No claims are made regarding performance or stability. 1 Not included for use on the Dimension Vista test menu. Refer to the package insert of currently available lots for specific analyte and stability claims. Iron (TIBC)* 1 LH Lidocaine Lithium N-Acetylprocainamide (NAPA) Netilmicin* 1 Nortriptyline 1 PAP 1 Phenobarbital Phenytoin Phenytoin (Free) 1 Primidone 1 Procainamide Progesterone 1 Prolactin Propranolol 1 PSA PSA (Free) PTH-MM* 1 Quinidine 1 Salicylate SHBG (Sex Hormone Binding Globulin) 1 Somatomedin-C* 1 T3 (Free) T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) TBG 1 Testosterone 1 Testosterone (Free) 1 Theophylline Thyroglobulin (Tg)* 1 Tobramycin Tricyclic Antidepressants (TCA) Screen TSH Valproic Acid Valproic Acid (Free) 1 Vancomycin Vitamin B 12 Cat # Liquichek Immunoassay Plus Control Quantity 360 Trilevel (4 of each level) x 5 ml 361 Level x 5 ml 362 Level x 5 ml 363 Level x 5 ml 360X Trilevel MiniPak (1 of each level)... 3 x 5 ml 267 Level x 2.5 ml 268 Level x 2.5 ml 269 Level x 2.5 ml 268X Trilevel MiniPak (1 of each level)...3 x 2.5 ml Visit myeinserts.com to view product inserts online, anytime. 43

47 Immunoassay Controls Lyphochek Immunoassay Plus Control A lyophilized control for monitoring the precision of immunoassay and therapeutic drug monitoring procedures, eliminating the need for individual controls. Lyphochek Immunoassay Plus Control is made from human serum and is suitable for most test methods. Human serum based Assayed for over 1100 methods Comprehensive analyte menu Includes therapeutic drugs 3 year shelf life at 2 8 C POCT Methods Listed 25-Hydroxy Vitamin D 11-Deoxycortisol 17-α-Hydroxyprogesterone Acetaminophen ACTH Aldosterone Alphafetoprotein (AFP) Amikacin Amiodarone* Amitriptyline Androstenedione Angiotensin I Anti-Thyroglobulin (Anti-Tg)* Anti-Thyroperoxidase (Anti-TPO)* C-Peptide Caffeine Calcitonin Carbamazepine Carbamazepine (Free) CEA Chloramphenicol Cortisol Cyclosporine** Desipramine DHEA DHEA Sulfate Digoxin Disopyramide Estradiol Estriol (Free) Estriol (Total)* Estrogen (Total) Ethosuximide Ferritin Flecainide Folate Fructosamine FSH Gastrin Gentamicin Glucagon hcg hcg-β Subunit hgh Imipramine Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Immunoreactive Trypsinogen (IRT)* Insulin Iron Iron (TIBC) LH Lidocaine Lithium N-Acetylprocainamide (NAPA) Netilmicin* Nortriptyline PAP Phenobarbital Phenytoin Phenytoin (Free) Primidone Procainamide Progesterone Prolactin PSA PSA (Free) Quinidine Salicylate SHBG (Sex Hormone Binding Globulin)* Somatomedin-C T3 (Free) T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) TBG Testosterone Testosterone (Free) Theophylline Thyroglobulin (Tg) Tobramycin Tricyclic Antidepressants (TCA) Screen TSH Valproic Acid Valproic Acid (Free) Vancomycin Vitamin B 12 *No claims are made regarding performance or stability. **Values are not provided. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Immunoassay Plus Control Quantity 370 Trilevel (4 of each level) x 5 ml 371 Level x 5 ml 372 Level x 5 ml 373 Level x 5 ml 370X Trilevel MiniPak (1 of each level)... 3 x 5 ml 44 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

48 Immunoassay Controls Liquichek Specialty Immunoassay Control A unique, liquid assayed control designed to complement the popular Lyphochek and Liquichek Immunoassay Plus Controls. This product is specially formulated to include more complex analytes and provide excellent open-vial stability. Liquid, human serum based 2 year shelf life at -20ºC to -70ºC 30 day open-vial stability at 2 8ºC for most analytes Multi-analyte control including Intact PTH, 25-Hydroxy Vitamin D, Anti-Tg and Anti-TPO Assayed values available for most automated immunoassay analyzers and manual methods 25-OH Vitamin D insert listing also includes LC-MS-MS values for Vitamin D2 and D3 POCT Methods Listed 25-Hydroxy Vitamin D Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) C-Peptide Erythropoietin (EPO) Insulin Growth Factor I (IGF-I) Refer to the package insert of currently available lots for specific analyte and stability claims. Intact PTH Osteocalcin Cat # Liquichek Specialty Immunoassay Control Quantity 359 Level LTA x 5 ml 364 Level x 5 ml 365 Level x 5 ml 366 Level x 5 ml 359X Four Level MiniPak (1 of each level) x 5 ml Lyphochek Anemia Control A control specifically designed to provide low/deficient values for many analytes specific to anemia, including very low TSH values for ultrasensitive TSH testing. 3 year shelf life at 2 8 C Includes very low Ferritin, Folate, Vitamin B 12 and TSH values Ferritin Folate Iron Iron (TIBC) Iron (UIBC) Transferrin TSH Vitamin B 12 Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Anemia Control Quantity 500 Single Level x 3 ml 500X MiniPak x 3 ml Visit myeinserts.com to view product inserts online, anytime. 45

49 Immunoassay Controls Liquichek Tumor Marker Control A liquid, human based control for monitoring the precision of tumor marker testing procedures. This multi-analyte control has 3 levels and features 17 cancer antigens and common tumor markers. Human based Very high levels of cancer antigens (CA) and Ferritin Very low PSA level for highly sensitive PSA test methods 30 day open-vial stability at 2 8 C for most analytes 2 year shelf life when stored frozen (-20 C to -70 C) POCT Methods Listed β-2-microglobulin Alphafetoprotein (AFP) CA 125 CA 15-3 CA 19-9 CA CA 72-4* CEA Cyfra 21-1* Ferritin hcg hcg-β Subunit Insulin Growth Factor I (IGF-I) PAP Prolactin PSA PSA (Free) Thyroglobulin (Tg) *International Use Only. Not available for diagnostic use in the United States. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Tumor Marker Control Qty Cat # Qty 547 Level x 2 ml 548 Level x 2 ml 549 Level x 2 ml 548X Trilevel MiniPak (1 of each level)... 3 x 2 ml Lyphochek Tumor Marker Plus Control A lyophilized, trilevel, multi-analyte control designed to monitor the precision of tumor marker testing procedures, featuring 24 cancer antigens and common tumor markers. Human serum based High levels of cancer antigens (CA) and Ferritin Ultra-low PSA levels designed for high sensitive PSA methods 14 day reconstituted stability at 2 8 C for most analytes 3 year shelf life at 2-8 C POCT Methods Listed β-2-microglobulin ACTH Aldosterone Alphafetoprotein (AFP) CA 15-3 CA 19-9 CA CA 50* CA 72-4* CA 125 Calcitonin CASA* CEA Cyfra 21-1* Ferritin hcg hcg-β Subunit Neuron Specific Enolase (NSE)* PAP Prolactin PSA PSA (Free) S-100* Thyroglobulin (Tg) *International Use Only. Not available for diagnostic use in the United States. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Tumor Marker Plus Control Qty Cat # Qty 367 Level x 2 ml 368 Level x 2 ml 369 Level x 2 ml 368X Trilevel MiniPak (1 of each level)... 3 x 2 ml 46 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

50 Immunoassay Controls Lyphochek Maternal Serum Control A lyophilized, trilevel control with analytes at clinically significant levels to monitor the precision of maternal serum analysis frequently performed during triple marker screening. Human serum based Very elevated hcg and hcg-β Subunit (around 100,000 miu/ml) Very low levels of Free Estriol and AFP 3 year shelf life at 2 8 C 10 day reconstituted stability at 2 8 C Alphafetoprotein (AFP) Estriol (Free) hcg (Total hcg and β-hcg) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Maternal Serum Control Quantity 220 Trilevel (2 of each level) x 5 ml 220X Trilevel MiniPak (1 of each level)... 3 x 5 ml Lyphochek Fertility Control A lyophilized control designed to assess the test precision of those analytes most frequently assayed during fertility or pregnancy. Elevated hcg and hcg-β Subunit levels allow laboratories to check dilution protocols for patient samples. Human serum based Elevated hcg and hcg-β Subunit (around 20,000 miu/ml) 3 year shelf life at 2 8 C 7 day reconstituted stability at 2 8 C POCT Methods Listed Alphafetoprotein (AFP) Digitoxin Estradiol Estriol (Free) Estriol (Total)* Ferritin FSH hcg *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. hcg-β Subunit LH Progesterone Testosterone Cat # Lyphochek Fertility Control Quantity 480 Trilevel (4 of each level) x 5 ml 481 Level x 5 ml 482 Level x 5 ml 483 Level x 5 ml 480X Trilevel MiniPak (1 of each level)... 3 x 5 ml Visit myeinserts.com to view product inserts online, anytime. 47

51 Immunoassay Controls Lyphochek Hypertension Markers Control A trilevel control designed to monitor the precision of test procedures for Renin and other analytes associated with hypertension disorders. 2 year shelf life at 2 8 C 21 day reconstituted stability at 2 8 C for most analytes ACTH ADH* Aldosterone Cortisol Renin *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Hypertension Markers Control Quantity 600 Trilevel (2 of each level) x 2 ml 600X Trilevel MiniPak (1 of each level)... 3 x 2 ml Lyphochek Endocrine Control A human serum based control designed to monitor the precision of plasma catecholamine testing procedures, including HPLC. The analytes are spiked at critical concentrations to cover the dynamic range of the assays. Defibrinated human plasma based 2 year shelf life at 2 8 C 3 day open-vial stability at 2 8 C Dopamine Epinephrine Norepinephrine Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Endocrine Control Quantity 535 Bilevel (6 of each level) x 10 ml 535X Bilevel MiniPak (1 of each level) x 10 ml Lyphochek Urine Bone Markers Control A bilevel, human urine based control designed to monitor the precision of tests for urinary markers of osteoporosis management and bone resorption. Human urine based 3 year shelf life at 2 8 C 14 day reconstituted stability at 2 8 C β-2-microglobulin* C-Telopeptide (CTx) Creatinine Deoxypyridinoline (DPD) N-Telopeptide (NTx) Pyridinium Crosslinks (DPD + PYD) Pyridinoline (PYD)* *No claims are made for expected values or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Urine Bone Markers Control Quantity 406 Bilevel (3 of each level)... 6 x 2 ml 406X Bilevel MiniPak (1 of each level) x 2 ml 48 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

52 Therapeutic Drug Monitoring Controls Lyphochek Whole Blood Immunosuppressant Control Liquichek Whole Blood Immunosuppressant Control Liquichek Therapeutic Drug Monitoring Control (TDM) Lyphochek Therapeutic Drug Monitoring Control (TDM) See page 36 for information about our EQAS Programs. See page 124 for helpful product accessories. 49

53 Therapeutic Drug Monitoring Controls The Critical Status of Therapeutic Drug Levels Requires Dependable Analytic Performance Be confident when reporting TDM results, regardless of the platform you use, by assessing performance with reliable, consistent QC products. Monitoring therapeutic drug levels is performed for patient safety; results are vitally important to patient outcome. The desired goal, to maintain a relatively constant concentration of medication, is imperative for effective treatment. Simply administering a standard dose of medication at regular intervals does not guarantee control within the desired therapeutic range because individuals absorb, metabolize, utilize and eliminate drugs at different rates. A variety of other factors: age, overall health, genetic makeup, other medications, and diet may also impact concentration levels on any given day. Because so many factors impact the measurement of therapeutic drug levels, laboratories depend greatly on quality control products to monitor the analytical performance of their drug testing procedures. Bio-Rad controls provide value assignments for over 50 TDM methods to aid in providing consistently reliable results. The liquid formulation of our new Liquichek Whole Blood Immunosuppressant control, with Everolimus, is compatible with chromatography and most immunoassay methods. Lyphochek Whole Blood Immunosuppressant Control A unique, lyophilized control with the flexibility to monitor the precision of test procedures for three widely prescribed immunosuppressant drugs across a wide range of popular instruments. Five individual levels that range from low to very high concentrations High concentrations of Cyclosporine suitable for C2 monitoring 3 year shelf life at 2 8ºC 14 day reconstituted stability at 2 8ºC 30 day reconstituted stability at -20ºC to -70ºC Assayed values for most test methods POCT Methods Listed Cyclosporine Sirolimus Tacrolimus (FK 506) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Whole Blood Immunosuppressant Control Qty Cat # Qty 274 Level x 2 ml 275 Level x 2 ml 276 Level x 2 ml 277 Level x 2 ml 278 Level x 2 ml 279X Five Level MiniPak (1 of each level) x 2 ml 50 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

54 Therapeutic Drug Monitoring Controls Liquichek Whole Blood Immunosuppressant Control A liquid, human blood based control to monitor the testing of immunosuppressant drugs, including Everolimus. Suitable for immunoassay and chromatographic methods. Liquid, human blood based 3 year shelf life at -20ºC to -70ºC 14 day open-vial stability at 2-8ºC for most analytes Convenient trilevel packaging includes 3 levels containing low to high concentrations of Cyclosporine, Sirolimus and Tacrolimus Levels 2 and 3 offer low- and mid-levels of Everolimus Level 4 contains higher concentrations of Everolimus and Tacrolimus, and is suitable for Cyclosporine C2 monitoring Cyclosporine Everolimus Sirolimus Tacrolimus (FK 506) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Whole Blood Immunosuppressant Control Quantity 657 Trilevel (4 of each level) x 2 ml 659 Level x 2 ml 657X 4 Level MiniPak x 2 ml Liquichek Therapeutic Drug Monitoring Control (TDM) A trilevel, liquid, assayed control containing a comprehensive menu of therapeutic drugs, as well as many common ligands. Liquid, human serum based 3 year shelf life at -20 C to -70 C Includes Diazepam and Methotrexate 180 day unopened-vial stability at 2 8 C for most analytes 30 day open-vial stability at 2 8 C for most analytes POCT Methods Listed Acetaminophen Amikacin Amitriptyline* Caffeine Carbamazepine Carbamazepine (Free) Chloramphenicol Clonazepam* Cortisol Cyclosporine* Desipramine Diazepam Digoxin Disopyramide Estriol (Total)* Ethosuximide Flecainide* Gentamicin Haloperidol* Imipramine* Lidocaine Lithium Methotrexate N-Acetylprocainamide (NAPA) *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Nortriptyline* Phenobarbital Phenytoin Phenytoin (Free) Primidone Procainamide Propranolol Quinidine Salicylate T3 (Free) T3 (Total) T3 Uptake/T-Uptake T4 (Free)* T4 (Total) Theophylline Tobramycin Tricyclic Antidepressants (TCA) Screen TSH Valproic Acid Valproic Acid (Free) Vancomycin Cat # Liquichek Therapeutic Drug Monitoring Control (TDM) Qty Cat # Qty 724 Trilevel (4 of each level) x 5 ml 725 Level x 5 ml 726 Level x 5 ml 727 Level x 5 ml 724X Trilevel MiniPak (1 of each level)... 3 x 5 ml Visit myeinserts.com to view product inserts online, anytime. 51

55 Therapeutic Drug Monitoring Controls Lyphochek Therapeutic Drug Monitoring Control (TDM) A human serum based control that contains over 40 analytes with assayed values at three clinically significant levels. Human serum based Includes Methotrexate 3 year shelf life at 2 8 C 30 day reconstituted stability at 2 8 C for most analytes POCT Methods Listed Acetaminophen Amikacin Amiodarone* Amitriptyline Caffeine Carbamazepine Carbamazepine (Free) Chloramphenicol Cortisol Cyclosporine Desipramine Digoxin Disopyramide Estriol (Total)* Ethosuximide Flecainide* Gentamicin Haloperidol* Imipramine Lidocaine Lithium Methotrexate N-Acetylprocainamide (NAPA) Netilmicin* Nortriptyline Phenobarbital Phenytoin Phenytoin (Free) Primidone Procainamide Propranolol Quinidine Salicylate T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) Theophylline Tobramycin Tricyclic Antidepressants (TCA) Screen TSH Valproic Acid Valproic Acid (Free) Vancomycin *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Therapeutic Drug Monitoring Control (TDM) Quantity 450 Trilevel (4 of each level) x 5 ml 451 Level x 5 ml 452 Level x 5 ml 453 Level x 5 ml 450X Trilevel MiniPak (1 of each level)... 3 x 5 ml 52 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

56 Chemistry Controls Serum Chemistry Controls Liquid Assayed Multiqual Liquid Unassayed Multiqual Liquid Assayed Multiqual Premium Lyphochek Assayed Chemistry Control Lyphochek Unassayed Chemistry Control (Human) Liquichek Unassayed Chemistry Control (Human) Liquichek Lipids Control Liquichek Pediatric Control Liquichek Ethanol/Ammonia Control Urine Chemistry Controls Lyphochek Quantitative Urine Control Liquichek Microalbumin Control Liquichek Urine Chemistry Control Urinalysis Controls Liquichek Urinalysis Control quantify Control quantify Plus Control See pages & 39 for information about our EQAS Programs. See page 124 for helpful product accessories. 53

57 Chemistry Controls Maximum Confidence, Minimal Hassle with Clinical Chemistry Control Solutions from Bio-Rad With more tests run on integrated systems and modular platforms, you need the right combination of quality control products to keep pace with the spectrum of clinical tests you perform. With the move to integrated systems and modular platforms, Clinical Chemistry now encompasses a greater number of laboratory tests. Despite the need for a control to cover each test, managers must always consider material and labor costs. To help address the challenges of such constraints, chemistry controls from Bio-Rad are designed to provide good shelf life and reliable open-vial stability. Bio-Rad controls like the Multiqual liquid serum chemistry controls and our Liquichek Ethanol/Ammonia Control are easy and cost effective to use. Running an extensive combination of chemistry tests on a single platform requires careful consideration to determine efficient utilization of quality controls. A single control with a broad mix of analytes can save time, provide quality control coverage for a maximum number of tests, and minimize use of assay and single analyte control products. Multiqual is a trilevel, liquid serum chemistry control that comes ready to use and contains a comprehensive list of 80 analytes covering a broad range of routine chemistry tests. No matter how carefully handled, some analytes remain susceptible to the presence of, or will interact with, other biochemicals. Ammonia is one such component; so when it is necessary to employ specific controls, you ll want to rely on our Serum Chemistry Liquichek Ethanol/Ammonia Control. It is the only quality control product offering three levels of measurement for ammonia (normal, elevated and toxic); it also includes ethanol. 54 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

58 Serum Chemistry Controls Liquid Assayed and Unassayed Multiqual Comprehensive, liquid, human serum based general chemistry controls, available in both assayed and unassayed configurations with multiple fill sizes. All offer a wide range of claimed analytes. Each level is sold separately. 3 ml and 10 ml Fill Sizes 3 year shelf life at -20 C to -70 C 30 day unopened stability at 2 8 C for most analytes 14 day open-vial stability at 2 8 C for most analytes 2.5 ml Fill Size Offers more than 60 analytes for the Dimension Vista test menu 3 year shelf life at -20ºC to -50ºC 30 day unopened (unpunctured) stability when stored refrigerated at 2 8 C for most analytes 5 day open-vial (punctured) stabilityfor all analytes when stored at 2 8ºC 7 day unopened (unpunctured) stability when stored on-board the Dimension Vista at 2 8 C POCT Methods Listed for Liquid Assayed Multiqual Acetaminophen Acid Phosphatase (Total)* Albumin Alkaline Phosphatase (ALP) Alpha-1-Antitrypsin Alpha-Hydroxybutyrate Dehydrogenase (αhbdh)* ALT/SGPT Amikacin* Amylase Amylase (Pancreatic)* Apolipoprotein A-1 Apolipoprotein B AST/SGOT Bilirubin (Direct) Bilirubin (Neonatal)* Bilirubin (Total) Calcium (Ionized)* Calcium (Total) Carbamazepine Ceruloplasmin Chloride Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Cholinesterase CK-MB Isoenzyme* 1 CO 2 Complement C3 Complement C4 Copper* Cortisol* Creatine Kinase (CK) Creatinine Digoxin Ethanol Ferritin Gentamicin GGT Globulin* Glucose Haptoglobin Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Iron Iron (TIBC) Iron (UIBC)* Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) LAP Arylamidase* Lipase Lithium Magnesium Osmolality* PAP* 1 Phenobarbital Phenytoin Phospholipids* Phosphorus Potassium Prealbumin Protein Electrophoresis* Protein (Total) Salicylate Sodium T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) Theophylline Tobramycin Transferrin Triglycerides TSH Urea* Urea Nitrogen Uric Acid Valproic Acid Vitamin B 12 Zinc* 1 No claims are made regarding performance or stability. *Not included for use on the Dimension Vista test menu. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquid Assayed Multiqual Qty 694 Level x 3 ml 695 Level x 3 ml 696 Level x 3 ml 695X Trilevel MiniPak (1 of each level)... 3 x 3 ml 337 Level x 2.5 ml 338 Level x 2.5 ml 339 Level x 2.5 ml 338X Trilevel MiniPak (1 of each level)...3 x 2.5 ml Cat # Liquid Unassayed Multiqual Qty 697 Level x 10 ml 698 Level x 10 ml 699 Level x 10 ml 698X Trilevel MiniPak (1 of each level)... 3 x 10 ml Visit myeinserts.com to view product inserts online, anytime. 55

59 Serum Chemistry Controls Liquid Assayed Multiqual Premium A liquid, human serum based comprehensive chemistry control that includes general chemistry, Immunology and Therapeutic Drug Monitoring (TDM) analytes. This assayed trilevel control contains 95 claimed analytes. 3 year shelf life at -20 C to -70 C 14 day open-vial stability at 2-8 C for most analytes Thawed and unopened stability for 30 days at 2-8 C for most analytes Includes CRP Offers 7 additional Immunology analytes, including Cystatin C Contains 8 additional TDM analytes, including Vancomycin Offers Bile Acids Acetaminophen Acid Phosphatase (Total) Albumin Alkaline Phosphatase (ALP) Alpha-1-Acid Glycoprotein* Alpha-1-Antitrypsin Alpha-Hydroxybutyrate Dehydrogenase (βhbdh) ALT/SGPT Amikacin Amylase Amylase (Pancreatic) Anti-CCP* Apolipoprotein A-1 Apolipoprotein B ASO* AST/SGOT Beta-2-Microglobulin* Bile Acids* Bilirubin (Direct) Bilirubin (Neonatal) Bilirubin (Total) Caffeine* Calcium (Ionized) Calcium (Total) Carbamazepine Ceruloplasmin Chloride Cholesterol Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Cholinesterase CO 2 Complement C3 Complement C4 Copper Cortisol Creatine Kinase (CK) Creatinine C-Reactive Protein (CRP)* Cystatin C* Digoxin Disopyramide* Ethanol Ferritin Gentamicin GGT Globulin Glucose Haptoglobin Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Iron Iron (TIBC) Iron (UIBC) Kappa Light Chain* Lactate Dehydrogenase (LDH) Lactate (Lactic Acid) Lambda Light Chain* LAP Arylamidase Lidocaine* Lipase Lithium Magnesium Methotrexate* NAPA* Osmolality Phenobarbital Phenytoin Phospholipids Phosphorus Potassium Prealbumin Procainamide* Protein (Total) Protein Electrophoresis Quinidine* Salicylate Sodium T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) Theophylline Tobramycin Transferrin Triglycerides TSH Urea Urea Nitrogen Uric Acid Valproic Acid Vancomycin* Vitamin B 12 Zinc Refer to the package insert of currently available lots for specific analyte and stability claims. *New analytes included in Liquid Assayed Multiqual Premium. ** **Available outside the US only. Cat # Liquid Assayed Multiqual Premium Quantity 284 Level x 5 ml 285 Level x 5 ml 286 Level x 5 ml 285X Trilevel MiniPak (1 of each level)... 3 x 5 ml 56 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

60 Serum Chemistry Controls Lyphochek Assayed Chemistry Control and Lyphochek Unassayed Chemistry Control (Human) These controls provide a comprehensive analyte menu and good stability for enzymes and CO 2. No special diluents are required and both are compatible with major instruments and methodologies. Human serum based 3 year shelf life at 2 8 C 30 day frozen reconstituted stability for most analytes 7 day open-vial reconstituted stability at 2 8 C for most analytes Available in 5 ml and 10 ml fill sizes POCT Methods Listed for Lyphochek Assayed Chemistry Control Acetaminophen Acid Phosphatase (Total) Albumin Alkaline Phosphatase (ALP) Alpha-1-Antitrypsin Alpha-Hydroxybutyrate Dehydrogenase (αhbdh) Alphafetoprotein (AFP) ALT/SGPT Amylase Amylase (Alpha) Amylase (Pancreatic) Apolipoprotein A-1 Apolipoprotein B AST/SGOT Bilirubin (Direct) Bilirubin (Indirect) Bilirubin (Total) Calcium Calcium (Ionized) Carbamazepine CEA Ceruloplasmin Chloride Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Cholinesterase CO 2 Complement C3 Complement C4* Copper Cortisol Creatine Kinase (CK) Creatinine Digoxin Gentamicin GGT GLDH Globulin Glucose Haptoglobin hcg-β Subunit Immunoglobulin A (IgA) 1 Available in Lyphochek Assayed Chemistry Control only. *No claim is made for expected value or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Immunoglobulin G (IgG) Immunoglobulin M (IgM) Iron Iron (TIBC) Iron (UIBC) Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) LAP Arylamidase Lipase Lithium Magnesium Osmolality PAP Phenobarbital Phenytoin Phosphorus Potassium Protein Electrophoresis Protein (Total) PSA 1 Salicylate Sodium T3 (Free) T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) TBG Theophylline Tobramycin Transferrin Triglycerides TSH Urea Urea Nitrogen Uric Acid Valproic Acid Vancomycin Vitamin B 12 Zinc Cat # Lyphochek Assayed Chemistry Control Qty Cat # Lyphochek Unassayed Chemistry Control (Human) Qty C C X Level x 5 ml Level x 5 ml Bilevel MiniPak (1 of each level) x 5 ml 731 Level x 5 ml 732 Level x 5 ml 730X Bilevel MiniPak (1 of each level) x 5 ml C Level x 10 ml C Level x 10 ml 323X Bilevel MiniPak (1 of each level) x 10 ml Visit myeinserts.com to view product inserts online, anytime. 57

61 Serum Chemistry Controls Liquichek Unassayed Chemistry Control (Human) A comprehensive, stable, liquid control designed to monitor the precision of general and special chemistry tests. Liquid, human serum based 2 year shelf life at -20 C to -70 C 15 day open-vial stability at 2 8 C for most analytes Usable across most major chemistry instruments Acetaminophen Acid Phosphatase (Total) Albumin Aldolase Alkaline Phosphatase (ALP) Alpha-Hydroxybutyrate Dehydrogenase (αhbdh) ALT/SGPT Amylase AST/SGOT Bilirubin (Direct)* Bilirubin (Indirect)* Bilirubin (Total) Calcium Calcium (Ionized)* Carbamazepine Chloride Cholesterol (HDL)* Cholesterol (Total) CO 2 Copper Cortisol Creatine Kinase (CK) Creatinine Digoxin Ethanol Folate Gentamicin GGT GLDH* Globulin Glucose Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Iron Iron (TIBC) Iron (UIBC)* Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) LAP Arylamidase* Lipase Lithium Magnesium Osmolality PAP* Phenobarbital Phenytoin Phospholipids Phosphorus Potassium Protein (Total) Protein Electrophoresis Pseudocholinesterase Salicylate Sodium T3 (Free)* T3 (Total) T3 Uptake/T-Uptake T4 (Free)* T4 (Total) Theophylline Tobramycin Transferrin Triglycerides TSH Urea Nitrogen Uric Acid Valproic Acid Vancomycin Vitamin B 12 Zinc *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Unassayed Chemistry Control (Human) Quantity 691 Level x 10 ml 692 Level x 10 ml 690X Bilevel MiniPak (1 of each level) x 10 ml Liquichek Lipids Control A human serum based control that provides the laboratory with two distinct analyte levels for lipids analysis. It contains C-Reactive Protein in levels optimized for high-sensitivity C-Reactive Protein (hs-crp) assays. Liquid, human serum based 3 year shelf life at -20 C to -70 C 14 day open-vial stability at 2 8 C POCT Methods Listed Apolipoprotein A-1 Apolipoprotein B C-Reactive Protein Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Lipoprotein (a) Triglycerides Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Lipids Control Quantity 641 Level x 3 ml 642 Level x 3 ml 640X Bilevel MiniPak (1 of each level) x 3 ml 58 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

62 Serum Chemistry Controls Liquichek Pediatric Control A liquid control designed to monitor the precision of analyte test procedures important to neonatal testing. Four Bilirubin parameters are available at two clinically significant levels. 4 ml Fill Size Liquid 3 year shelf life at -20 C to -70 C 3 month stability when stored unopened at 2 8ºC 14 day open-vial stability at 2 8 C 2.5 ml Fill Size Dimension Vista vials offer ready-to-use convenience for on-board refrigerated storage Shared lot numbers and Unity peer groups with existing Pediatric configuration Offers 10 analytes for the Dimension Vista test menu 3 year shelf life at -20ºC to -50ºC 45 day stability when stored unopened on-board at 2 8ºC ** Bilirubin (Direct) Bilirubin (Indirect)* Bilirubin (Neonatal)* Bilirubin (Total) Caffeine Calcium Chloride Glucose Magnesium Phenylalanine* Potassium Sodium Theophylline *Not included for use on the Dimension Vista test menu. Refer to the package insert of currently available lots for specific analyte and stability claims. 14 day open-vial (punctured) stability for all analytes when stored on-board at 2 8ºC 2-D barcode technology for quick and easy product insert and vial label scanning **Not all products may be available in all countries. Cat # Liquichek Pediatric Control Qty Cat # Qty 354 Level x 4 ml 355 Level x 4 ml 353X Bilevel MiniPak (1 of each level) x 4 ml 176 Level x 2.5 ml 177 Level x 2.5 ml 178X Bilevel MiniPak (1 of each level)....2 x 2.5 ml Liquichek Ethanol/Ammonia Control A liquid control used to monitor the precision of Ethanol and Ammonia test procedures in the clinical laboratory. 3 ml Fill Size Normal, elevated and toxic concentrations of Ammonia 2 year shelf life at 2 8 C 20 day open-vial stability at 2 8 C 2.5 ml Fill Size Dimension Vista vials offer ready-to-use convenience for on-board refrigerated storage Shared lot numbers and Unity peer groups with existing Ethanol/Ammonia configuration 2 year shelf life at 2 8ºC Ammonia Ethanol Refer to the package insert of currently available lots for specific analyte and stability claims. 20 day open-vial (punctured) stability when stored at 2 8ºC 2-D barcode technology for quick and easy product insert and vial label scanning POCT Methods Listed Cat # Liquichek Ethanol/Ammonia Control Qty Cat # Qty 544 Level x 3 ml 545 Level x 3 ml 546 Level x 3 ml 545X Trilevel MiniPak (1 of each level)... 3 x 3 ml 271 Level x 2.5 ml 272 Level x 2.5 ml 273 Level x 2.5 ml 272X Trilevel MiniPak (1 of each level)...3 x 2.5 ml Visit myeinserts.com to view product inserts online, anytime. 59

63 Urine Chemistry Controls Lyphochek Quantitative Urine Control Contains a comprehensive analyte menu for quantitative assays that monitor the precision for general urine chemistry, biogenic amines and hormones testing. This control also contains hcg (for qualitative pregnancy tests) and Microalbumin at levels suitable for monitoring assay precision during the early stages of proteinuria and associated nephropathy. Human urine based 2 year shelf life at 2 8 C for most analytes Comprehensive analyte menu and method listing 3-Methoxytyramine 5-Aminolevulinic Acid (ALA) 5-HIAA 11-β-Hydroxy-Androsterone* 11-β-Hydroxy-Etiocholanolone* 17-Hydroxycorticosteroids 11-Ketoandrosterone* 11-Ketoetiocholanolone* 17-Ketosteroids 17-Ketogenic Steroids Aldosterone AMP (Cyclic) Androsterone* Arsenic Barbiturates* Calcium Chloride Copper* Coproporphyrin Cortisol (Free) Creatine* Creatinine Cystine* Dehydroepiandrosterone* Dopamine Epinephrine Estriol (Total)* Etiocholanolone* Glucose Homovanillic Acid (HVA) Hydroxyproline (Free)* Hydroxyproline (Total) Iron Lead Magnesium Mercury Metanephrine Metanephrine (Total) Microalbumin Norepinephrine Normetanephrine Osmolality ph Phosphorus Porphyrins (Total) Potassium Pregnancy (Qualitative) Pregnanetriol* Protein (Total) Sodium Specific Gravity Urea Urea Nitrogen Uric Acid Uroporphyrins Vanillylmandellic Acid (VMA) Zinc* *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Quantitative Urine Control Quantity 376 Level 1, Normal x 10 ml 377 Level 2, Abnormal x 10 ml 375X Bilevel MiniPak (1 of each level) x 10 ml Liquichek Microalbumin Control A liquid, human urine based control, designed using human albumin, for monitoring the precision of Microalbumin test procedures across a wide range of popular instruments. Liquid, human urine based 2 year shelf life at 2 8ºC 90 day open-vial stability at 2 8ºC Assayed values available for most test methods POCT Methods Listed Creatinine Microalbumin Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Microalbumin Control Quantity 378 Level x 10 ml 379 Level x 10 ml 374X Bilevel MiniPak (1 of each level) x 10 ml 60 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

64 Urine Chemistry and Urinalysis Controls Liquichek Urine Chemistry Control A liquid, human urine based control ideal for monitoring the precision of urine chemistry testing procedures. This control provides assayed values for urine tests commonly performed on chemistry analyzers and some manual methods. 10 ml Fill Size Assayed for quantitative Microalbumin and visual pregnancy tests 2 year shelf life at 2 8 C 30 day open-vial stability at 2 8 C 2.5 ml Fill Size Offers 13 analytes to match the Dimension Vista test menu 30 day open-vial (punctured) stability for all analytes when stored at 2 8ºC POCT Methods Listed Amylase Calcium Chloride Cortisol* Creatinine Glucose Magnesium Microalbumin Osmolality* ph* *Not included for use on the Dimension Vista test menu. Refer to the package insert of currently available lots for specific analyte and stability claims. Phosphorus Potassium Pregnancy (Qualitative)* Protein (Total) Sodium Specific Gravity* Urea* Urea Nitrogen Uric Acid Cat # Liquichek Urine Chemistry Control Qty Cat # Qty 397 Level x 10 ml 398 Level x 10 ml 395X Bilevel MiniPak (1 of each level) x 10 ml 195 Level x 2.5 ml 196 Level x 2.5 ml 198X Bilevel MiniPak (1 of each level)....2 x 2.5 ml Liquichek Urinalysis Control Specifically designed for urine dipstick and microscopic testing, this control is available in 12 ml glass vials. Liquid, human urine based Designed for dipstick and microscopic analysis 30 day open-vial stability at 2 25 C 2.5 year shelf life at 2 8 C Color-coded peer group reports available POCT Methods Listed Bilirubin Blood Clarity Color Creatinine Glucose Ketones Leukocytes Microalbumin Microscopics (RBC, WBC, Crystals, Casts) Nitrite Osmolality Refer to the package insert of currently available lots for specific analyte and stability claims. ph Pregnancy (hcg) Protein (Total) Protein-to-Creatinine Ratio Specific Gravity Urobilinogen Cat # Liquichek Urinalysis Control Quantity 435 Bilevel (6 of each level) x 12 ml 436 Level x 12 ml 437 Level x 12 ml 435X Bilevel MiniPak (1 of each level) x 12 ml Visit myeinserts.com to view product inserts online, anytime. 61

65 Urinalysis Controls quantify Control A control designed to monitor the precision of urine dipstick testing, available in 12 ml ready-to-use dropper bottles. Liquid Designed for dipstick testing 2 year shelf life at 2-8ºC 31 day open-vial stability at 2-25ºC Color-coded peer group reports available POCT Methods Listed Albumin Albumin-to-Creatinine Ratio Ascorbic Acid* Bilirubin Blood Creatinine Glucose Hemoglobin (HGB) Ketones Leukocytes Microalbumin Nitrite *Tested and found to be negative. Refer to the package insert of currently available lots for specific analyte and stability claims ph Pregnancy (hcg) Protein (Total) Protein-to-Creatinine Ratio Specific Gravity Urobilinogen Cat # quantify Control Quantity 975 Bilevel (3 of each level)... 6 x 12 ml 975X Bilevel MiniPak (1 of each level) x 12 ml quantify Plus Control A combination urine dipstick and microscopic control, available in either 12 ml centrifuge tubes or 120 ml flip-top squeeze bottles. Liquid Designed for dipstick and microscopic analysis 2 year shelf life at 2-8ºC 31 day open-vial stability at 2-25ºC Color-coded peer group reports available POCT Methods Listed quantify Plus Level I L Leukocytes neg. trace +/small ++/mod. +++/large Day of Month Example Peer Group Report Albumin Albumin-to-Creatinine Ratio Ascorbic Acid* Bilirubin Blood Creatinine Glucose Hemoglobin (HGB) Ketones Leukocytes *Tested and found to be negative. Refer to the package insert of currently available lots for specific analyte and stability claims. Microalbumin Microscopics (RBC, WBC, Crystals, Casts) Nitrite ph Pregnancy (hcg) Protein (Total) Protein-to-Creatinine Ratio Specific Gravity Urobilinogen Cat # quantify Plus Control Qty Cat # Qty 995 Bilevel (5 of each level)/tube x 12 ml 995X Bilevel MiniPak (1 of each level)/tube x 12 ml 962 Bilevel (2 of each level)/bottle x 120 ml 963 Level 1/Bottle... 4 x 120 ml 964 Level 2/Bottle... 4 x 120 ml 962X Bilevel MiniPak (1 of each level)/bottle... 2 x 120 ml 62 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

66 Cardiac Assessment Controls Liquichek Cardiac Markers Plus Control LT Liquichek Cardiac Markers Plus Control Liquichek Homocysteine Control Liquichek Cardiac Markers Control LT Liquichek Cardiac Markers Control LT, Level Low Liquichek CK/LD Isoenzyme Control Additional Information Target Values for Cardiac Assessment Controls See page 39 for information about our EQAS Programs. See page 124 for helpful product accessories. 63

67 Cardiac Assessment Controls Cardiac Marker Assessment: The Right QC Products Align with Your Laboratory Foremost in helping laboratories address the growing complexity of measuring multiple Cardiac Markers at increasingly sensitive levels. Accurate diagnosis of a cardiac event (myocardial infarction) is a pivotal decision that often relies on cardiac marker test results. Is the patient in your Emergency Department having a heart attack in need of immediate attention, or are they at risk of a future event and should be referred for further evaluation? The decision carries sizeable consequences for both patient and caregiver. reliability across the entire range of detection. The challenge for laboratorians comes with analytes, like Troponin I (TnI), which lack universal standardization and are diagnostic at exceedingly low levels of analysis. These inescapable situations mandate the need to have precisely the right quality control materials; not merely a one-size-fits-all answer, but a solution that conforms to your laboratory s needs. With the complex array of markers available for cardiac assessment, the laboratory may have, and use, multiple platforms for detection of several cardiac markers presenting in a broad range of concentrations. For performance assurance and quality results, it s important to use controls that indicate Ever responsive to customer needs, Bio-Rad has introduced Liquichek Cardiac Marker Plus Control LT products for sensitive TnI assays. Designed for use on specific platforms, these products allow laboratories to select the low level TnI value best suited to the 99th percentile limit on their platform. Relative Troponin I percentage, compared to Liquichek Cardiac Markers Plus Control LT, Level 1: 100% 120% 60% 40% 64 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

68 Cardiac Assessment Controls Liquichek Cardiac Markers Plus Control LT A comprehensive cardiac assessment control designed to monitor precision of test procedures at lower Troponin levels. 3 ml Fill Size Liquid, human serum based 3 year shelf life at -20 C to -70 C 20 day open-vial stability at 2 8 C for most analytes Choice of four low Troponin I levels (1, 1A, 1B and 1C) Includes values for Troponin T (GEN 4 and hs), and hs-crp Level Low offers lower target values for analytes other than Troponin I 2.5 ml Fill Size Offers 7 analytes for the Dimension Vista cardiac assessment test menu 10 day unopened (unpunctured) stability when stored refrigerated at 2-8ºC 10 day open-vial (punctured) stability for all analytes when stored at 2-8ºC POCT Methods Listed Refer to page 71 for an overview of CRP levels in Bio-Rad Controls. For Liquichek D-dimer Control, see page 88. BNP CK (Total) CK-MB Isoenzyme CRP Digitoxin Homocysteine* Myoglobin NT-proBNP *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Troponin I Troponin T ** **Not all products may be available in all countries. Cat # Liquichek Cardiac Markers Plus Control LT Quantity 146 Level x 3 ml 147 Level x 3 ml 148 Level x 3 ml 149 Level Low... 6 x 3 ml 146X 147X 148X 149X Level 1 MiniPak x 3 ml Level 2 MiniPak x 3 ml Level 3 MiniPak x 3 ml Level Low MiniPak x 3 ml Level 1A x 3 ml Level 1B x 3 ml Level 1C... 6 x 3 ml 27104X 27105X 27106X Level 1A MiniPak x 3 ml Level 1B MiniPak x 3 ml Level 1C MiniPak x 3 ml 297 Level 1C...6 x 2.5 ml 298 Level x 2.5 ml 299 Level x 2.5 ml 298X Trilevel MiniPak (1 of each level)...3 x 2.5 ml Visit myeinserts.com to view product inserts online, anytime. 65

69 Cardiac Assessment Controls Liquichek Cardiac Markers Plus Control A comprehensive cardiac assessment control designed to monitor precision of test procedures across a wide range of Troponin target values. Assayed values available for multiple systems. Liquid, human serum based 3 year shelf life at -20 C to -70 C 20 day open-vial stability at 2 8 C for most analytes Includes values for Troponin T (GEN 4 and hs), and hs-crp POCT Methods Listed BNP CK (Total) CK-MB Isoenzyme CRP Digitoxin Homocysteine* Myoglobin NT-proBNP Troponin I Troponin T *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte, stability and listed instruments. Refer to page 71 for an overview of CRP levels in Bio-Rad Controls. For Liquichek D-dimer Control, see page 88. Cat # Liquichek Cardiac Markers Plus Control Quantity 180 Trilevel (2 of each level) x 3 ml 181 Level x 3 ml 182 Level x 3 ml 183 Level x 3 ml 180X Trilevel MiniPak (1 of each level)... 3 x 3 ml Liquichek Homocysteine Control A trilevel, single analyte control designed to monitor Homocysteine precision across a wide range of target values for multiple platforms. Liquid, human serum based 3 year shelf life at -10 C to -70 C 30 day open-vial stability at 2 8 C Includes values on all three levels for HPLC and automated immunoassays (Abbott, Beckman Coulter, Roche and Siemens) POCT Methods Listed Analyte Homocysteine Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Homocysteine Control Quantity 287 Level x 1 ml 288 Level x 1 ml 289 Level x 1 ml 288X Trilevel MiniPak (1 of each level)... 3 x 1 ml 66 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

70 Cardiac Assessment Controls Liquichek Cardiac Markers Control LT A cardiac assessment control designed to monitor the precision of test procedures for low Troponin T levels. Assayed solely for Roche systems. Liquid, human serum based 2 year shelf life at -20 C to -70 C 10 day open-vial stability at 2 8 C for most analytes Includes values for Troponin T (GEN 4) CK-MB Isoenzyme Digitoxin Homocysteine* Myoglobin NT-proBNP Troponin T *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte, stability and listed instruments. For Liquichek D-dimer Control, see page 88. Cat # Liquichek Cardiac Markers Control LT Qty Cat # Qty 645 Trilevel (2 of each level) x 3 ml 646 Level x 3 ml 647 Level x 3 ml 648 Level x 3 ml 645X Trilevel MiniPak (1 of each level)... 3 x 3 ml Liquichek Cardiac Markers Control LT, Level Low A cardiac assessment control designed to monitor the precision of test procedures for low Troponin I levels. Assayed solely for the Siemens ADVIA Centaur. Liquid, human serum based 2 year shelf life at -20 C to -70 C CK-MB Isoenzyme Digitoxin Homocysteine* Myoglobin Troponin I *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte, stability and listed instruments. For Liquichek D-dimer Control, see page 88. Cat # Liquichek Cardiac Markers Control LT, Level Low Quantity 649 Level Low... 6 x 3 ml 649X Level Low MiniPak x 3 ml Visit myeinserts.com to view product inserts online, anytime. 67

71 Cardiac Assessment Controls Liquichek CK/LD Isoenzyme Control A liquid control that features analytes used in cardiac profile testing and protein electrophoresis. Assayed for most methods including instruments, immunoinhibition kits and electrophoresis. Liquid, human serum based 2 year shelf life at -20 C to -70 C 10 day open-vial stability at 2 8 C Contains Isoenzymes for CK and LDH Albumin CK (Total) CK Electrophoresis CK-MB Isoenzyme Globulin LD Electrophoresis LD-1 Isoenzyme LDH Protein (Total) Protein Electrophoresis Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek CK/LD Isoenzyme Control Quantity 671 Level x 1 ml 672 Level x 1 ml 670X Bilevel MiniPak (1 of each level) x 1 ml Liquichek Cardiac Markers Plus Control LT and Cardiac Markers Plus Control Comparison Chart Choose from multiple controls for an even wider range of values For some clinical situations, adequate monitoring of assay precision across the analytical measuring range may have to come from more than one control material. This chart presents a sample of the options available from Bio-Rad, to allow each laboratory to choose the products that best suit their needs. Plus LT, Level Low Plus LT, Level 1 Plus, Level 1 Plus LT, Level 2 Plus, Level 2 Plus LT, Level 3 Plus, Level 3 Catalog Number Total CK (U/L) ,060 1,060 CK-MB (ng/ml) hs-crp (mg/dl) Digitoxin (ng/ml) Myoglobin (ng/ml) NT-proBNP (pg/ml) ,150 3,485 Troponin I (ng/ml) Troponin T (ng/ml) D-dimer Use Liquichek D-dimer Control (see page 88) Homocysteine Use Liquichek Homocysteine Control (see page 66) Recovered values may vary with methodology. For specific analyte, open-vial stability, methods, mean values and ranges, refer to the package inserts of currently available lots at myeinserts.com 68 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

72 Immunology/Protein Controls Quality Control Products Liquichek Immunology Control Lyphochek Immunology Plus Control Liquichek Elevated CRP Control Liquichek Rheumatoid Factor Control Liquichek Spinal Fluid Control Liquichek Autoimmune Controls Additional Information Target CRP Levels in Bio-Rad Controls See page 37 for information about our EQAS Programs. See page 124 for helpful product accessories. 69

73 Immunology/Protein Controls Immunology/Protein Assays: The More Sample Types You Run The More You re Going to Want Bio-Rad QC Immunology / Protein controls with more than 30 analytes available for peer comparison in interlaboratory reports. In conditions of both health and disease, physicians assess the functional well-being of a patient s immune system via analysis of a wide array of proteins. Immunological proteins can indicate disorders of the immune system through either elevated or reduced concentrations and often an intricate interaction of multiple proteins plays a part in the pathology and clinical symptoms of a disorder. Clinical immunologists also study proteins to detect transplant rejection. Bio-Rad has a comprehensive selection of Immunology/Protein controls available; several are multi-analyte controls with value assignments for a host of different test methods. Our quality control products come in liquid formulations, convenient to use and helpful in minimizing manual labor. These products are designed for quality control with a variety of sample types including serum, spinal fluid and test methods including immunofixation. Electrophoresis laboratory customers, please note that our Liquichek Spinal Fluid Control contains oligoclonal banding patterns useful in electrophoresis testing. If your laboratory performs ANA analysis, you ll want to read more about the Liquichek Autoimmune Controls; particularly the ANA positive controls that contain specific staining patterns that can be used as positive patterns or for those detecting autoantibodies using IFA procedures each control is provided with an endpoint titer. 70 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

74 Immunology/Protein Controls Liquichek Immunology Control A trilevel, liquid, comprehensive serum protein control with assayed values for a wide range of methods. Liquid, human serum based Three distinct levels Comprehensive list of methods 2 year shelf life at -20ºC to -70 C 30 day open-vial stability at 2 8 C for most analytes POCT Methods Listed α-1-acid Glycoprotein α-1-antitrypsin α-2-macroglobulin β-2-microglobulin ADNase B Albumin Antistreptolysin O (ASO) Antithrombin III (AT III) Apolipoprotein A-1 Apolipoprotein B C1 Inhibitor Ceruloplasmin CH50* Complement C3 Complement C4 CRP Cystatin C Ferritin Haptoglobin Hemopexin* Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin G Subclasses 1 4 Immunoglobulin M (IgM) Kappa Light Chain Lambda Light Chain Lipoprotein (a) Prealbumin Properdin Factor B Protein (Total) Retinol Binding Protein (RBP) Rheumatoid Factor Soluble Transferrin Receptor (stfr)* Transferrin *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Immunology Control Quantity 591 Level x 1 ml 592 Level x 1 ml 593 Level x 1 ml 590X Trilevel MiniPak (1 of each level)... 3 x 1 ml 594 Level x 3 ml 595 Level x 3 ml 596 Level x 3 ml Target CRP Levels in Bio-Rad Controls Values reflect typical assayed values for these products. Recovered values may vary depending on methodology. Liquichek Cardiac Markers Plus Control LT Liquichek Lipids Control Liquichek Cardiac Markers Plus Control Lyphochek Immunology Plus Control Liquichek Immunology Control Liquichek Elevated CRP Control CRP (mg/l) Visit myeinserts.com to view product inserts online, anytime. 71

75 Immunology/Protein Controls Lyphochek Immunology Plus Control A bilevel, lyophilized control with assayed values for serum proteins on the most popular methods. Lyophilized, human serum based 3 year shelf life at 2 8 C 15 day reconstituted stability at 2 8 C POCT Methods Listed α-1-acid Glycoprotein α-1-antitrypsin α-2-macroglobulin β-2-microglobulin Albumin Antistreptolysin O (ASO) Ceruloplasmin Complement C1q* Complement C3 Complement C4 CRP Haptoglobin Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Kappa Light Chain Lambda Light Chain Prealbumin Retinol Binding Protein (RBP) Rheumatoid Factor Transferrin *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Immunology Plus Control Quantity 430 Bilevel (6 of each level) x 1 ml 430X Bilevel MiniPak (1 of each level) x 1 ml Liquichek Elevated CRP Control A liquid, assayed serum control with elevated levels of C-Reactive Protein. Liquid, human serum based 3 year shelf life at -20ºC to -70ºC 30 day open-vial stability at 2-8ºC Target CRP levels of 15, 90 and 180 mg/l Analyte CRP Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Elevated CRP Control Quantity 254 Level x 1 ml 255 Level x 1 ml 256 Level x 1 ml 255X Trilevel MiniPak (1 of each level)... 3 x 1 ml 72 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

76 Immunology/Protein Controls Liquichek Rheumatoid Factor Control A liquid, trilevel control designed to monitor the precision of rheumatoid factor testing procedures, including nephelometric and latex agglutination methods. Liquid, human serum based Normal, slightly elevated and greatly elevated RF levels 2 year shelf life at -20ºC to -70 C 30 day open-vial stability at 2 8 C Analyte Rheumatoid Factor Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Rheumatoid Factor Control Quantity 501 Level x 2 ml 502 Level x 2 ml 503 Level x 2 ml 502X Trilevel MiniPak (1 of each level)... 3 x 2 ml Liquichek Spinal Fluid Control A liquid, bilevel product designed to monitor the precision of automated and manual procedures for the analysis of proteins and other critical analytes assayed in cerebrospinal fluid. 3 ml Fill Size Liquid Oligoclonal banding in Level 2 2 year shelf life at 2 8 C 30 day open-vial stability at 2 8 C 2.5 ml Fill Size Dimension Vista vials offer ready-to-use convenience for on-board refrigerated storage Shared lot numbers and Unity peer groups with existing Spinal Fluid configuration 2D barcode for quick and easy product insert and vial label scanning 30 day open-vial (punctured) stability for all analytes when stored at 2 8ºC Albumin Chloride Glucose Immunoglobulin A (IgA)* Immunoglobulin G (IgG) Immunoglobulin M (IgM)* Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) Protein (Total) Protein Electrophoresis* 1 Sodium *Not for use on the Dimension Vista 1 Prealbumin, Albumin, α-1-globulin, α-2-globulin, β-globulin, γ-globulin. Refer to the package insert of currently available lots for specific analyte and stability claims. ** Cat # Liquichek Spinal Fluid Control Qty Cat # **Not all products may be available in all countries. Qty 751 Level x 3 ml 752 Level x 3 ml 750X Bilevel MiniPak (1 of each level) x 3 ml 303 Level x 2.5 ml 304 Level x 2.5 ml 302X Bilevel MiniPak (1 of each level)....2 x 2.5 ml Visit myeinserts.com to view product inserts online, anytime. 73

77 Immunology/Protein Controls Liquichek Autoimmune Controls Individual controls for monitoring the precision of autoimmune assays using indirect immunofluorescence (IFA). Liquid, human serum based 2 year shelf life at 2 8 C 6 month open-vial stability at 2 8 C Package Configuration Negative and weak positive controls packaged separately 0.5 ml per vial Refer to the package insert of currently available lots for specific analyte data. Cat # Liquichek Autoimmune Controls Quantity 107 Liquichek ANA Control, Homogeneous Pattern...3 x 0.5 ml 108 Liquichek ANA Control, Speckled Pattern....3 x 0.5 ml 111 Liquichek ANA Control, Nucleolar Pattern....3 x 0.5 ml 112 Liquichek ANA Control, Centromere Pattern....3 x 0.5 ml 118 Liquichek ANA Control, Mitotic Spindle Pattern...2 x 0.5 ml 113 Liquichek Anti-SS-B Control....2 x 0.5 ml 114 Liquichek Anti-SS-A Control....2 x 0.5 ml 115 Liquichek Anti-Sm Control....2 x 0.5 ml 116 Liquichek Anti-RNP Control....2 x 0.5 ml 117 Liquichek Anti-Scl-70 Control...2 x 0.5 ml 119 Liquichek Anti-nDNA Control....3 x 0.5 ml 127 Liquichek Anti-Mitochondrial Control....3 x 0.5 ml 129 Liquichek Anti-Smooth Muscle Control....3 x 0.5 ml 130 Liquichek Autoimmune Negative Control x 0.5 ml 131 Liquichek ANA Controls Set, Positive...4 x 0.5 ml (Homogeneous, Speckled, Centromere and Nucleolar Patterns) 74 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

78 Diabetes/Hemoglobin Controls Quality Control Products Liquichek Diabetes Control Lyphochek Diabetes Control Lyphochek Hemoglobin A1C Linearity Set Lyphochek Hemoglobin A 2 Control Meter Trax See page 38 for information about our EQAS Programs. See page 124 for helpful product accessories. 75

79 Diabetes/Hemoglobin Controls Monitor Hemoglobin A1C Testing with Superior Quality Controls from Bio-Rad HbA1C Values for More than 30 Methods Including HPLC, Immunoassay and Point-of-Care Instruments Hemoglobin A1C (HbA1C) levels correlate with average blood sugar levels but don t have the extent of variation seen in random blood sugar measurements. Glucose levels that have not been controlled well are reflected in elevated HbA1C levels. While normal levels vary slightly by laboratory, typically HbA1C levels less than 7.0% indicate good glucose control; in poorly controlled diabetes, levels are generally 8.0% or above. The higher the HbA1C, the higher the risks may be of developing other health complications related to diabetes. The use of quality controls from Bio-Rad can assist your laboratory in delivering quality HbA1C results. Liquichek and Lyphochek Diabetes Controls, our multilevel controls for monitoring HbA1C and Total Hemoglobin test procedures, have value assignment listings for over 30 methods including HPLC, Immunoassay and point-of-care methodologies. Liquichek Diabetes Control A liquid, human whole blood based control designed to monitor the precision of hemoglobin tests associated with diabetes monitoring, including Hemoglobin A1C and Total Hemoglobin. Available in three critical levels. Hemoglobin (Total) Hemoglobin A1C Refer to the package insert of currently available lots for specific analyte and stability claims. 1 ml Fill Size 3 year shelf life at -10ºC to -70ºC 6 month shelf life at 2 8ºC 14 day open-vial stability at 2 8ºC Higher third level to monitor your assay range Value assignment listings for over 30 methods * 2 ml Fill Size Dimension Vista vials offer ready-to-use convenience for on-board refrigerated storage Shared lot numbers and Unity peer groups with 1 ml fill size 3 year shelf life at -10ºC to -50ºC 6 month shelf life at 2 8ºC 14 day open-vial stability at 2 8ºC POCT Methods Listed *Not all products may be available in all countries. Cat # Liquichek Diabetes Control Qty Cat # Qty 171 Level x 1 ml 172 Level x 1 ml 173 Level x 1 ml 172X Trilevel MiniPak (1 of each level)... 3 x 1 ml 291 Level x 2 ml 292 Level x 2 ml 293 Level x 2 ml 292X Trilevel MiniPak (1 of each level)... 3 x 2 ml 76 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

80 Diabetes/Hemoglobin Controls Lyphochek Diabetes Control A human whole blood based control used to monitor the assay precision of hemoglobin fractions associated with diabetes, including Hemoglobins A1, A1C and F. Human whole blood based control 3 year shelf life at 2 8 C 7 day reconstituted stability at 2 8 C Extensive value assignment listings POCT Methods Listed Hemoglobin (Total Glycated) Hemoglobin (Total) Hemoglobin A1* Hemoglobin A1C Hemoglobin F *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Diabetes Control Quantity 740 Bilevel (3 of each level)...6 x 0.5 ml 740X Bilevel MiniPak (1 of each level)....2 x 0.5 ml Lyphochek Hemoglobin A1C Linearity Set A human whole blood based control designed to verify linearity throughout the patient reportable range of Hemoglobin A1C assays. Human whole blood based 4 significant levels 3 year shelf life at 2 8ºC 7 day reconstituted stability at 2 8ºC Linearity Web software available on Assayed values available for common analyzers: Bio-Rad Analyzers Other Analyzers D-10 Beckman Coulter SYNCHRON Systems VARIANT Siemens ADVIA 1650 VARIANT II/Turbo Siemens Dimension Series Analyte Hemoglobin A1C Refer to the package insert of currently available lots for specific analyte and stability claims. Roche COBAS INTEGRA & Hitachi Systems Tosoh A1c 2.2 Plus & G7 Cat # Lyphochek Hemoglobin A1C Linearity Set Quantity 120 Set (1 of each level)....4 x 0.5 ml Visit myeinserts.com to view product inserts online, anytime. 77

81 Diabetes/Hemoglobin Controls Lyphochek Hemoglobin A 2 Control A human whole blood based control designed to monitor the precision of automated and manual procedures for the measurement of hemoglobin variants, including Hemoglobins A 2, F and S. Human whole blood based control Ideal for hemoglobin variant analysis 2 year shelf life at 2 8ºC 21 day reconstituted stability at 2 8 C for most methods Hemoglobin A 2 Hemoglobin F Hemoglobin S Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Hemoglobin A 2 Control Quantity 553 Bilevel (2 of each level)...4 x 0.5 ml 553X Bilevel MiniPak (1 of each level)....2 x 0.5 ml Meter Trax Control A human whole blood based control that can be used for Glucose, Hemoglobin and Hematocrit testing on point-of-care instruments. This control can be used as part of a laboratory program to assess operator competence. Human whole blood based control Glucose and Hemoglobin stable for 31 days at 2 25ºC after opening Hematocrit stable for 31 days at 2 8ºC after opening 6 month shelf life at 2-8ºC POCT Methods Listed Glucose Hematocrit (HCT) Hemoglobin (Total) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Meter Trax Control Quantity 970 Trilevel (2 of each level) x 2 ml 971 Low Level... 6 x 2 ml 972 Mid Level x 2 ml 973 High Level x 2 ml 970X Trilevel MiniPak (1 of each level)... 3 x 2 ml 78 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

82 Hematology and Coagulation Controls Hematology Controls Liquichek Reticulocyte Control (A) Liquichek Hematology Control (A Liquichek Reticulocyte Control (A-I) Liquichek Hematology Control (C) Liquichek Reticulocyte Control (C) Liquichek Hematology Control (S) Liquichek Reticulocyte Control (S) Liquichek Hematology Control (X) Liquichek Reticulocyte Control (X) Liquichek Hematology-16 Control Liquichek Hematology-16T Control Liquichek Sedimentation Rate Control Coagulation Controls Lyphochek Coagulation Control Lyphochek Hemostasis Control Liquichek D-dimer Control See pages for information about our EQAS Programs. See page 124 for helpful product accessories. 79

83 Hematology and Coagulation Controls Hematology & Coagulation Controls Cover Multiple and Parameters Coverage includes: complete blood counts, 3- or 5-part WBC differential counts, reticulocytes, sedimentation rate, coagulation tests, clotting factor assays and D-dimer. Our Hematology and Reticulocyte controls are available for vendor-specific Hematology analyzers with either 3- or 5-part differential technology. Versatile Liquichek Hematology 16/16T Controls are specifically designed for hematology analyzers measuring up to 16 parameters/3-part WBC differential. These controls can be used on a variety of manual sampling or automatic cap-piercing platforms. Liquichek Sedimentation Rate Control, for QC on most instrument platforms, has a market leading shelf-life of 540 days. To assess Coagulation procedures, customers find Lyphochek Coagulation Control useful for coverage of coagulation tests on most systems because it has 48 hour open-vial stability at 2-25ºC a vast improvement over the 8-hour stability claims of other coagulation controls. For an extended Coagulation factors menu (e.g. Plasminogen, Protein C, Protein S and others) look at the Lyphochek Hemostasis Control. Try our 4 level D-dimer control with a 3 year shelf-life, exceptional precision performance and its robust range of value targets for assessment at medical decision points. Liquichek Reticulocyte Control (A) An assayed whole blood control for evaluating the precision of automated methods of reticulocyte counting. 75 day shelf life at 2 8ºC 16 day open-vial stability at 2 8ºC Assayed values for Abbott CELL-DYN 3500 and 3700 Parameters Immature Reticulocyte Fraction (IRF) Reticulocyte (Retic) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Reticulocyte Control (A) Quantity 854 Level x 3 ml 855 Level x 3 ml 855X Bilevel MiniPak (1 of each level) x 3 ml 80 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

84 For Abbott Systems Hematology Controls Liquichek Hematology Control (A) An assayed hematology control for evaluating the performance of Abbott CELL-DYN analyzers with 3-part and 5-part differential technology. Assayed values for the Abbott CELL-DYN 1700, 1800, 3200, 3500, 3700 and CELL-DYN Ruby analyzers 75 day shelf life at 2 8 C 8 day open-vial stability at 2 8 C Values provided for WIC, WOC and NOC methods POCT Methods Listed Parameters Basophils (BASO) % Basophils Eosinophils (EOS) % Eosinophils Granulocytes (GRAN) Hematocrit (HCT) Hemoglobin (Total) Lymphocytes (LYMPH) % Lymphocytes Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) MID Monocytes (MONO) % Monocytes Neutrophils (NEUT) % Neutrophils Nucleated Red Blood Cells (NRBC) Nucleated Red Blood Cells/100 WBC (NRBC/WBC%) Platelecrit (PCT) Platelet Volume Distribution Width (PDW) Platelets (PLT) Platelets Impedance Method (PLTi) Red Blood Cell Distribution Width (RDW) Red Blood Cells (RBC) Red Blood Cells, Optical (RBCo) White Blood Cells (WBC) White Optical Count (WOC) White Impedance Count (WIC) Nucleated Optical Count (NOC) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Hematology Control (A) Quantity 865 Trilevel (4 of each level) x 3 ml 866 Low x 3 ml 867 Normal... 4 x 3 ml 868 High x 3 ml 865X Trilevel MiniPak (1 of each level)... 3 x 3 ml Liquichek Reticulocyte Control (A-I) An assayed reticulocyte control for use with the Abbott CELL-DYN 4000 and CELL-DYN Sapphire hematology analyzers. Assayed values are also provided for manual methods. 75 day shelf life at 2 8 C 14 day open-vial stability at 2 8 C Parameters Immature Reticulocyte Fraction (IRF) Red Blood Cells (RBC) Reticulocyte (Retic) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Reticulocyte Control (A-I) Quantity 916 Level x 3 ml 917 Level x 3 ml 915X Bilevel MiniPak (1 of each level) x 3 ml Visit myeinserts.com to view product inserts online, anytime. 81

85 Hematology Controls For Beckman Coulter Systems Liquichek Hematology Control (C) An assayed hematology control for evaluating the performance of Beckman Coulter hematology analyzers with complete CBC and VCS 5-part differential technology. Assayed values for the Coulter STKS, LH 500, LH 700, MAXM, HmX, and GEN-S analyzers 105 day shelf life at 2 8 C 14 day open-vial stability at 2 8 C Parameters Basophils (BASO) Eosinophils (EOS) Hematocrit (HCT) Hemoglobin (HGB) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) *Values reported by analyzer are not for diagnostic use. 1 For Beckman Coulter LH only. Refer to the package insert of currently available lots for specific parameter and stability claims. Mean Platelet Volume (MPV) Monocytes (MONO) Neutrophils (NEUT) Platelecrit (PCT)* Platelet Distribution Width (PDW)* Platelets (PLT) RDW-SD 1 Red Blood Cell Distribution Width (RDW) Red Blood Cells (RBC) White Blood Cells (WBC) Cat # Liquichek Hematology Control (C) Quantity 904 Trilevel (4 of each level) x 5 ml 905 Low x 5 ml 906 Normal... 4 x 5 ml 907 High x 5 ml 904X Trilevel MiniPak (1 of each level)... 3 x 5 ml Liquichek Reticulocyte Control (C) A human whole blood based control designed to monitor the performance of automated Beckman Coulter analyzers using VCS technology and New Methylene Blue stain. 14 day open-vial stability at 2 8 C 75 day shelf life at 2 8 C Three clinically significant levels available Parameters Immature Reticulocyte Fraction (IRF) Mean Reticulocyte Volume (MRV) Red Blood Cells (RBC) Reticulocyte (Retic) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Reticulocyte Control (C) Quantity 826 Level x 4 ml 827 Level x 4 ml 828 Level x 4 ml 827X Trilevel MiniPak (1 of each level)... 3 x 4 ml 82 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

86 For Siemens Systems Hematology Controls Liquichek Hematology Control (S) An assayed hematology control for use with Siemens hematology analyzers with 3-part and 5-part differential technology. 75 day shelf life at 2 8 C 14 day open-vial stability at 2 8 C Parameters Basophils (BASO) Cellular Hemoglobin Concentration Mean (CHCM) Eosinophils (EOS) Hematocrit (HCT) Hemoglobin (HGB) Hemoglobin Concentration Distribution Width (HDW) Large Unstained Cells (LUC) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) Monocytes (MONO) NEUT X NEUT Y Neutrophils (NEUT) Platelets (PLT) Red Blood Cell Distribution Width (RDW) Red Blood Cells (RBC) White Blood Cells (WBC) White Blood Cells Counts Measured in Perox Channel (WBCP Perox) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Hematology Control (S) Quantity 449 Trilevel (4 of each level)...12 x 3.5 ml 449X Trilevel MiniPak (1 of each level)...3 x 3.5 ml Liquichek Reticulocyte Control (S) An assayed reticulocyte control for use with Siemens hematology analyzers with automated reticulocyte counting methods. 75 day shelf life at 2 8 C 14 day open-vial stability at 2 8 C Parameters Cellular Hemoglobin Concentration Mean of Gated Red Blood Cells (CHCMg) Cellular Hemoglobin Concentration Mean of Reticulocytes (CHCMr) Mean Corpuscular Volume of Gated Red Blood Cells (MCVg) Mean Corpuscular Volume of Reticulocytes (MCVr) Mean Hemoglobin Content of All Gated Red Cells (CHg) Mean Hemoglobin Content of Reticulocytes (CHr) Refer to the package insert of currently available lots for specific parameter and stability claims. Reticulocyte (Retic) Total Red Blood Cell Counts in Retic Channel (Retic RBC) Cat # Liquichek Reticulocyte Control (S) Quantity 921 Level x 4 ml 922 Level x 4 ml 923 Level x 4 ml 922X Trilevel MiniPak (1 of each level)... 3 x 4 ml Visit myeinserts.com to view product inserts online, anytime. 83

87 Hematology Controls For Sysmex Systems Liquichek Hematology Control (X) An assayed hematology control for use with Sysmex hematology analyzers with 5-part differential technology. 75 day shelf life at 2 8 C Stable for 15 days open-vial or 15 samplings, whichever comes first, when stored at 2 8 C POCT Methods Listed Parameters Basophils (BASO) Eosinophils (EOS) Hematocrit (HCT) Hemoglobin (HGB) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) Monocytes (MONO) Neutrophils (NEUT) *No claims made for expected value or stability. Refer to the package insert of currently available lots for specific parameter and stability claims. Nucleated Red Blood Cells (NRBC) * Platelets (PLT) Platelets, Optical Count (PLT-o) * Red Blood Cell Distribution Width-CV (RDW-CV) Red Blood Cell Distribution Width-SD (RDW-SD) Red Blood Cells (RBC) White Blood Cells (WBC) Cat # Liquichek Hematology Control (X) Quantity 487 Trilevel (4 of each level)...12 x 4.5 ml 487X Trilevel MiniPak (1 of each level)...3 x 4.5 ml Liquichek Reticulocyte Control (X) An assayed reticulocyte control for use with Sysmex hematology analyzers with automated reticulocyte counting methods. 75 day shelf life at 2 8 C Stable for 15 days open-vial or 15 samplings, whichever comes first, when stored at 2 8 C Parameters Immature Reticulocyte Fraction (IRF) Red Blood Cells (RBC) Reticulocyte (Retic) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Reticulocyte Control (X) Quantity 926 Level x 3 ml 927 Level x 3 ml 928 Level x 3 ml 927X Trilevel MiniPak (1 of each level)... 3 x 3 ml 84 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

88 Hematology Controls Liquichek Hematology-16 Control Specifically designed for use on most hematology analyzers that measure up to 16 parameters and 3-part white blood cell differentials. This trilevel control can be used on either manual sampling or automatic cap-piercing instruments. 160 day shelf life at 2 8 C 21 day open-vial stability at 2 8 C Assayed for most 2 16 parameter instruments Stabilized human RBCs POCT Methods Listed Parameters Granulocytes (GRAN) Hematocrit (HCT) Hemoglobin (HGB) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) Mid-Sized Cells (MID) Monocytes (MONO) Platelets (PLT) Red Blood Cell Distribution Width (RDW) Red Blood Cells (RBC) White Blood Cells (WBC) Refer to the package insert of currently available lots for specific parameter and stability claims. Cat # Liquichek Hematology-16 Control Quantity 760 Trilevel (2 of each level) x 3 ml 761 Low x 3 ml 762 Normal... 6 x 3 ml 763 High x 3 ml 760X Trilevel MiniPak (1 of each level)... 3 x 3 ml Liquichek Hematology-16T Control A hematology reference control used in monitoring determinations of blood cell values on Sysmex and Abbott 3-part differential hematology analyzers. 105 day shelf life at 2 8ºC 14 day open-vial stability at 2 8ºC POCT Methods Listed Parameters Granulocytes (GRAN) Hematocrit (HCT) Hemoglobin (Total) LYMPH (W-SCC & W-SCR) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Platelet Volume (MPV) MID MXD (W-MCC & W-MCR) Refer to the package insert of currently available lots for specific parameter and stability claims. NEUT (W-LCC & W-LCR) Platelets (PLT) Red Blood Cell Distribution Width (RDW) Red Blood Cell Distribution Width-CV (RDW-CV) Red Blood Cell Distribution Width-SD (RDW-SD) Red Blood Cells (RBC) Spun Hematocrit (Spun HCT) White Blood Cells (WBC) Cat # Liquichek Hematology-16T Control Quantity 144 Trilevel (4 of each level)...12 x 2.5 ml 144X Trilevel MiniPak (1 of each level)...3 x 2.5 ml Visit myeinserts.com to view product inserts online, anytime. 85

89 Hematology Controls Liquichek Sedimentation Rate Control A bilevel, human whole blood control designed to monitor the precision of both manual and automated methods for measuring erythrocyte sedimentation rates. 31 day open-vial stability at C 540 day shelf life at C Assayed for over 20 automated and manual methods, including Westergren and Wintrobe Parameter Erythrocyte Sedimentation Rate (ESR) Refer to the package insert of currently available lots for specific parameter and stability claims. Liquichek Sedimentation Rate Control may be used with the following instruments and test methods BD Vacutainer Seditainer Chase Disposable Westergren Tubes Diesse Mini-Ves Diesse Ves-Matic 20 Diesse Ves-Matic 10 Vital Diagnostics Excyte M, 10, 40 Vital Diagnostics MICROsed-System Vital Diagnostics Monitor-S, J, J+ Fisherbrand Dispette 2 Greiner Bio-One SRS100/SRS20/SRT10 Polymedco Sedimat 60 Polymedco Sediplast RR Mechatronics StaRRsed Streck ESR-Auto Plus Westergren (Modified) Wintrobe Cat # Liquichek Sedimentation Rate Control Quantity 514 Level x 9 ml 515 Level x 9 ml 514X Bilevel MiniPak (1 of each level) x 9 ml 86 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

90 Coagulation Controls Lyphochek Coagulation Control A human plasma control for monitoring the precision of routine coagulation tests. It has an extended reconstituted stability that helps reduce waste and save money. 3 year shelf life at 2 8 C 48 hour open-vial stability at 2 25 C Representative PT values in seconds and International Normalized Ratio (INR) Normal and abnormal levels of PT, APTT, Fibrinogen, Antithrombin III and Thrombin Time Activated Partial Thromboplastin Time (APTT) Antithrombin III (AT III) Fibrinogen Prothrombin Time (PT) Thrombin Time (TT) Refer to the package insert of currently available lots for specific analyte and stability claims. For Use on a Variety of Systems Siemens BCS and CA, Diagnostica Stago STA, Instrumentation Laboratory ACL and ELECTRA, and Trinity Biotech AMAX Cat # Lyphochek Coagulation Control Quantity 744 Level x 1 ml 745 Level x 1 ml 746 Level x 1 ml 745X Trilevel MiniPak (1 of each level)... 3 x 1 ml Lyphochek Hemostasis Control A multi-analyte control for monitoring the precision of coagulation factor assays and selected thrombosis risk assays. Assayed values available for most leading hemostasis analyzers. 3 year shelf life at 2 8ºC 8 hour open-vial stability at 2-25 C, except for Protein S at 2 8ºC Activated Partial Thromboplastin Time (APTT) Antithrombin III (AT III) Factors II, V, VII, VIII, IX, X, XI and XII Fibrinogen Plasminogen Protein C (Functional) Protein S (Functional) Prothrombin Time (PT) Thrombin Time (TT) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Hemostasis Control Quantity 597 Level x 1 ml 598 Level x 1 ml 599 Level x 1 ml 598X Trilevel MiniPak (1 of each level)... 3 x 1 ml Visit myeinserts.com to view product inserts online, anytime. 87

91 Coagulation Controls Liquichek D-dimer Control Provides the laboratory with a liquid, 4 Level, human plasma-based control for monitoring the precision of D-dimer testing on most automated coagulation, chemistry and immunoassay analyzers. 3 year shelf life at -20 C to -70 C which allows for fewer crossover studies No reconstitution required 15 day open-vial stability at 2 8ºC POCT Methods Listed Popular Instruments for D-dimer Assays Instrument Level Low Level 1 Level 2 Level 3 Abbott Beckman Coulter Olympus AU biomerieux Biosite Triage Meter Pro Diagnostica Stago IL ACL Mitsubishi Pathfast Roche/Hitachi Cobas Siemens BCS Siemens Immulite 2000 Siemens Stratus Sysmex CA Series These are recommended levels. Refer to package insert for complete instrument listing. Analyte D-dimer Refer to the package insert of currently available lots for specific analyte and stability claims. Target Level D-dimer ng/ml (FEU)* Level Low 250 Level Level Level The values listed are approximate targets. The actual observed values will vary depending upon lot number, analyzer, reagent, method, and calibrator. * Fibrinogen Equivalent Units (FEU) = twice the mass of the D-DU (D-dimer units). Cat # Liquichek D-dimer Control Quantity Level Low... 6 x 1 ml Level x 1 ml Level x 1 ml Level x 1 ml 27102X Four Level MiniPak (1 of each level) x 1 ml 88 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

92 Blood Gas Controls Quality Control Products Liquichek Blood Gas Control Liquichek Blood Gas Plus E Control Liquichek Blood Gas Plus EGL Control Liquichek Blood Gas Plus CO-Oximeter Control (800 Series) Accessories and Additional Information Blood Gas Ampule Breaker Blood Gas Controls Analyte Chart See page 39 for information about our EQAS Blood Gas Program. 89

93 Blood Gas Controls Bio-Rad Offers a Selection of Blood Gas Controls to Suit Your Needs For blood gas analyzers with an expanded menu electrolytes, glucose and lactose. Blood gas results are time sensitive and provide medical specialists with vital information that typically requires immediate action. For this reason, in addition to the laboratory, blood gas instruments are commonly located at or near patient treatment areas Intensive Care Unit, Operating Room, Emergency Department and other acute care settings. These locations often pose a challenge for storing quality controls that require refrigeration. Bio-Rad offers aqueous and dye-based blood gas controls for daily QC with the option of being stored at room temperatures (up to 25 C). Bio-Rad s selections of blood gas controls are available to meet a variety of needs. Liquichek Blood Gas controls are available with or without electrolytes or with electrolytes, glucose and lactose. For packaging, controls are available in individual packs which contain one of three control levels. Unity Interlaboratory Program peer group comparison reports are available for our blood gas customers. Liquichek Blood Gas Control An aqueous control used to monitor the precision of the laboratory's measurement of ph, pco 2, and po 2 in blood gas instrumentation. Available in three levels 4 year shelf life at 18 25ºC Comprehensive list of instrument values Color coded for easy identification POCT Methods Listed pco 2 ph po 2 Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Blood Gas Control Quantity 571 Level x 1.7 ml 572 Level x 1.7 ml 573 Level x 1.7 ml 570X Trilevel MiniPak (3 of each level)...9 x 1.7 ml 90 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

94 Blood Gas Controls Liquichek Blood Gas Plus E Control An aqueous control used to monitor the precision of the laboratory's measurement of ph, pco 2, po 2 and electrolytes. Clear matrix 4 year shelf life at 2 25ºC Comprehensive list of instrument values POCT Methods Listed Calcium (Ionized) Chloride pco 2 ph po 2 Potassium Sodium Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Blood Gas Plus E Control Quantity 576 Level x 1.7 ml 577 Level x 1.7 ml 578 Level x 1.7 ml 575X Trilevel MiniPak (3 of each level)...9 x 1.7 ml Liquichek Blood Gas Plus EGL Control An aqueous control used to monitor the precision of the laboratory's measurement of ph, pco 2, po 2, electrolytes, glucose, lactate (lactic acid) and magnesium. Clear matrix 3 year shelf life at 2 8 C Can be stored for up to 12 months at C POCT Methods Listed Calcium (Ionized) Chloride Glucose Lactate (Lactic Acid) Lithium Magnesium pco 2 ph po 2 Potassium Sodium Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Blood Gas Plus EGL Control Quantity 511 Level x 1.7 ml 512 Level x 1.7 ml 513 Level x 1.7 ml 510X Trilevel MiniPak (3 of each level)...9 x 1.7 ml Visit myeinserts.com to view product inserts online, anytime. 91

95 Blood Gas Controls Liquichek Blood Gas Plus CO-Oximeter Control (800 Series) A combination control for use in monitoring the precision of the laboratory's measurement of blood gas, ion-selective electrode, biosensor and CO-Oximeter (Siemens 800 series) instrumentation. Aqueous matrix containing dyes Contains glucose and lactate 4 year shelf life at 2 8 C Can be stored for up to 12 months at C POCT Methods Listed Calcium (Ionized) Carboxyhemoglobin Chloride Deoxyhemoglobin Glucose Hemoglobin (Total) Lactate (Lactic Acid) Methemoglobin Oxyhemoglobin pco 2 ph po 2 Potassium Sodium Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Blood Gas Plus CO-Oximeter Control (800 Series) Quantity 504 Level x 1.7 ml 505 Level x 1.7 ml 506 Level x 1.7 ml 505X Trilevel MiniPak (3 of each level)...9 x 1.7 ml Blood Gas Ampule Breaker Designed to reduce the risk of injury when opening blood gas ampules. Protects hands from cuts Easy and convenient to use Reusable Cat # Blood Gas Ampule Breaker Quantity 587 Blood Gas Ampule Breaker...1 unit Blood Gas Controls Analyte Chart Analyte present Blood Gas Blood Gas Plus E Blood Gas Plus EGL Blood Gas Plus CO-Oximeter (800 Series) Chloride Calcium (Ionized) Carboxyhemoglobin Deoxyhemoglobin Glucose Hemoglobin (Total) Lactate (Lactic Acid) Lithium Magnesium Methemoglobin Oxyhemoglobin pco2 ph po2 Potassium Sodium 92 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

96 Toxicology Controls Drugs-of-Abuse Controls Liquichek Urine Toxicology Negative Control Liquichek Qualitative Urine Toxicology Control Lyphochek Urine Toxicology Control Liquichek Urine Toxicology Screen Controls Levels S1E & S2E Levels S1E & S2E Low Opiate Levels S1O & S2O Levels S1O & S2O Low Opiate Levels S1 & S Levels S1 & S2 Low Opiate Level S Levels S1S & S2S Screen Controls Gravimetric Reference Values Liquichek Urine Toxicology Confirmatory Controls Level C Levels C2 & C3 Low Opiate Levels C2 & C Level C Confirmatory Controls Gravimetric Reference Values Additional Controls Liquichek Opiate Control Specialty Toxicology Controls Liquichek Whole Blood Volatiles Control Liquichek Serum Volatiles Control Lyphochek Urine Metals Control Lyphochek Whole Blood Metals Control Lyphochek Whole Blood Control Lyphochek Benzo/TCA Set A Lyphochek Benzo/TCA Set B Lyphochek Drug Free Serum See page 124 for helpful product accessories. 93

97 Toxicology Drugs-of-Abuse Controls With More than 20 Controls for Drugs-of-Abuse Testing Methods You Can Choose with Confidence Bio-Rad has a control and the expertise to assist your laboratory in choosing the right control for your method of analysis. When monitoring the precision of screening, semi-quantitative, and confirmatory test procedures for drugs of abuse, each has its own unique challenges. Different methodologies, regulations and guidelines call for quality control materials spiked with purified drugs or drug metabolites at different concentrations. No matter how you define a standard drug panel, or what concentrations you need, Bio-Rad has a control for you. Choose from more than 20 controls with analytes at appropriate concentrations for a wide range of screening and confirmatory methods. Bio-Rad Drugs-of-Abuse Controls meet SAMHSA* and other agency guidelines and are made from human urine with ph, specific gravity and creatinine concentrations that fall within the limits of normal human urine. *United States Substance Abuse and Mental Health Services Administration Liquichek Urine Toxicology Negative Control Confirmed as negative for 32 commonly abused drugs. 3 year shelf life at 2 8ºC 60 day open-vial stability when stored refrigerated at 2 8ºC Use with screening or confirmatory methods Cat # Liquichek Urine Toxicology Negative Control Quantity 460 Negative Control x 20 ml 460X MiniPak x 20 ml Refer to the package insert of currently available lots for specific analyte and stability claims and detection limits of methods used. 94 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

98 Toxicology Drugs-of-Abuse Controls Analyte Target Values Negative (ng/ml) Positive (ng/ml) Liquichek Qualitative Urine Toxicology Control A liquid control designed for use with qualitative urine drug screen panels, including Point-of-Care (POC) drugs-of-abuse test kits like Bio-Rad TOX/See, Biosite Triage and other popular test kits. The package insert includes qualitative results (+/-) for popular kits and recovery values by gas chromatography (GC) and other quantitative methods. Human urine 3 year shelf life at 2 8 C 30 day open-vial stability at 2 25 C Negative and positive levels POCT Methods Listed Catalog Number Amphetamines d-amphetamine <125 2,000 d-methamphetamine <125 2,000 3, 4-Methylenedioxymethamphetamine (MDMA) < Barbiturates Secobarbital <80 1,000 Benzodiazepines Nordiazepam <50 3,000 Oxazepam <150 1,000 Cannabinoids 11-Nor-Δ-9-THC-9-COOH < Cocaine Benzoylecgonine <30 4,000 Ethanol (mg/dl) < Lysergic Acid Diethylamide (LSD) < Methadone < Methaqualone < Opiates Morphine (Free) <300 3,000 Oxycodone < Phencyclidine (PCP) < Propoxyphene < Tricyclic Antidepressants Nortriptyline <10 2,000 Cat # Liquichek Qualitative Urine Toxicology Control Quantity 454 Negative Level x 3 ml 455 Positive Level x 3 ml 454X Bilevel MiniPak (1 of each level) x 3 ml Refer to the package insert of currently available lots for specific analyte and stability claims and detection limits of methods used. Lyphochek Urine Toxicology Control Contains drugs of abuse at levels that show positive results on TOXI-LAB and other thin-layer chromatography systems. Human urine 3 year shelf life at 2 8 C 10 day reconstituted stability at 2 8 C or 30 day reconstituted stability at -10 C to -20ºC 11-Nor-Δ-9-THC-9-COOH Acetaminophen Benzoylecgonine Codeine d-amphetamine Glutethimide* Imipramine Meperidine* Methadone Methaqualone Morphine (Free) Oxazepam Phencyclidine (PCP) Phenobarbital Propoxyphene* Secobarbital *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Urine Toxicology Control Quantity C X Single Level x 25 ml MiniPak x 25 ml Visit myeinserts.com to view product inserts online, anytime. 95

99 Toxicology Drugs-of-Abuse Controls Liquichek Urine Toxicology Screen Controls Liquichek Urine Toxicology Control, Levels S1E & S2E A human urine control containing drugs of abuse at concentrations 20 25% above or below immunoassay screen cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC Cat # Levels S1E & S2E Qty Cat # For use with 2,000 ng/ml Opiate cutoff MiniPaks also available Qty 438 Level S1E x 10 ml Liquichek Urine Toxicology Control, Levels S1E Low Opiate & S2E Low Opiate A human urine control containing drugs of abuse at concentrations 20 25% above or below immunoassay screen cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC 439 Level S2E x 10 ml For use with 300 ng/ml Opiate cutoff MiniPaks also available Cat # Levels S1E Low Opiate & S2E Low Opiate Qty Cat # Qty 423 Level S1E Low Opiate x 10 ml 424 Level S2E Low Opiate x 10 ml Liquichek Urine Toxicology Control, Levels S1O & S2O A human urine control containing drugs of abuse at concentrations 20 50% below or above commonly used immunoassay screen cutoff levels. 2 year shelf life at -20 C to -70 C 30 day open-vial stability at 2 8 C 45 day closed vial stability at 2 8 C Includes Methamphetamine and Oxazepam For use with 2,000 ng/ml Opiate cutoff MiniPaks also available Cat # Levels S1O & S2O Qty Cat # Qty 673 Level S1O x 10 ml 676 Level S2O x 10 ml Liquichek Urine Toxicology Control, Levels S1O Low Opiate & S2O Low Opiate A human urine control containing drugs of abuse at concentrations 20 50% below or above commonly used immunoassay screen cutoff levels. 2 year shelf life at -20 C to -70 C 30 day open-vial stability at 2 8 C 45 day closed vial stability at 2 8 C Includes Methamphetamine and Oxazepam For use with 300 ng/ml Opiate cutoff MiniPaks also available Cat # Levels S1O Low Opiate & S2O Low Opiate Qty Cat # Qty 683 Level S1O Low Opiate x 10 ml 706 Level S2O Low Opiate x 10 ml Refer to the package insert of currently available lots for specific analyte and stability claims. 96 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

100 Toxicology Drugs-of-Abuse Controls Liquichek Urine Toxicology Control, Levels S1 & S2 A human urine control containing drugs of abuse at concentrations 20 25% above or below immunoassay screen cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC Cat # Levels S1 & S2 Qty Cat # For use with 2,000 ng/ml Opiate cutoff MiniPaks also available Qty 461 Level S x 10 ml 462 Level S x 10 ml Liquichek Urine Toxicology Control, Levels S1 Low Opiate & S2 Low Opiate A human urine control containing drugs of abuse at concentrations 20-25% above or below immunoassay screen cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC For use with 300 ng/ml Opiate cutoff MiniPaks also available Cat # Levels S1 Low Opiate & S2 Low Opiate Qty Cat # Qty 466 Level S1 Low Opiate x 10 ml 467 Level S2 Low Opiate x 10 ml Liquichek Urine Toxicology Control, Level S3 A human urine control containing drugs of abuse at elevated levels for immunoassay screening procedures. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC For use with 300 ng/ml Opiate cutoff MiniPaks also available Cat # Liquichek Urine Toxicology Control, Level S3 Quantity 463 Level S x 10 ml Liquichek Urine Toxicology Control, Levels S1S & S2S A human urine control containing six drugs of abuse at concentrations 20 25% above or below SAMHSA's* and other agencies' immunoassay screen cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8 C Targets lower Amphetamine and Cocaine cutoffs Includes MDMA Cat # Levels S1S & S2S Qty Cat # For use with the 2,000 ng/ml Opiate, 500 ng/ml Amphetamine and 150 ng/ml Cocaine cutoffs. MiniPaks also available Qty 409 Level S1S x 10 ml 419 Level S2S x 10 ml *United States Substance Abuse and Mental Health Services Administration (formerly NIDA) Refer to the package insert of currently available lots for specific analyte and stability claims. Visit myeinserts.com to view product inserts online, anytime. 97

101 Toxicology Drugs-of-Abuse Controls Which Screen Controls are Right for You? Please refer to the chart below to determine which Bio-Rad Drugs-of-Abuse Controls best suit your needs. Liquichek Urine Toxicology Screen Control Gravimetric Reference Values (ng/ml) Level S1E Low Opiate Level S2E Low Opiate Level S1E Level S2E Level S1 Low Opiate Level S2 Low Opiate Level S1 Level S2 Catalog Number Amphetamines d-amphetamine 750 1, ,250 d-methamphetamine 750 1, ,250 MDMA Barbiturates Secobarbital Benzodiazepines Lormetazepam Nordiazepam Oxazepam Cannabinoids 11-Nor-Δ-9-THC-9-COOH Cocaine Benzoylecgonine Ethanol (mg/dl) Lysergic Acid Diethylamide (LSD) Methadone Methaqualone Opiates Morphine (Free) ,500 2, ,500 2,500 Phencyclidine (PCP) Propoxyphene Tricyclic Antidepressants Nortriptyline 750 1, , , ,250 Refer to the package insert for performance and stability claims. 98 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

102 Toxicology Drugs-of-Abuse Controls Negative S1 Levels S2 Levels Level S3 0-25% Screening Cutoff +25% Elevated Level S3 Level S1O Low Opiate Level S2O Low Opiate Level S1O Level S2O Level S1S Level S2S SAMHSA* Screen Cutoffs (ng/ml) Catalog Number Amphetamines 2,000 d-amphetamine 750 1, , d-methamphetamine MDMA Barbiturates 1, Secobarbital Benzodiazepines Lormetazepam 1,000 Nordiazepam Oxazepam Cannabinoids Nor-Δ-9-THC-9-COOH Cocaine Benzoylecgonine Ethanol (mg/dl) Lysergic Acid Diethylamide (LSD) Methadone Methaqualone Opiates ,500 2,500 1,500 2,500 2,000 Morphine (Free) Phencyclidine (PCP) Propoxyphene Tricyclic Antidepressants 2,000 Nortriptyline Refer to the package insert for performance and stability claims. Visit myeinserts.com to view product inserts online, anytime. 99

103 Toxicology Drugs-of-Abuse Controls Liquichek Urine Toxicology Confirmatory Controls Liquichek Urine Toxicology Control, Level C1 A human urine control containing drugs of abuse at very low levels or at the Limits of Quantitation (LOQ) for confirmatory test methods. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC For use with 300 ng/ml Opiate cutoff MiniPaks also available Cat # Liquichek Urine Toxicology Control, Level C1 Quantity 441 Level C x 20 ml Liquichek Urine Toxicology Control, Levels C2 Low Opiate & C3 Low Opiate A human urine control containing drugs of abuse at concentrations 20 25% above or below confirmatory cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC Cat # Levels C2 Low Opiate & C3 Low Opiate Qty Cat # For use with 300 ng/ml Opiate cutoff MiniPaks also available Qty 468 Level C2 Low Opiate x 20 ml 469 Level C3 Low Opiate x 20 ml Liquichek Urine Toxicology Control, Levels C2 & C3 A human urine control containing drugs of abuse at concentrations 20 25% above or below confirmatory cutoff levels. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC Designed for use with 2,000 ng/ml Opiate, 250 ng/ml Amphetamine and 100 ng/ml Benzoylecgonine cutoff concentrations. MiniPaks also available Cat # Levels C2 & C3 Qty Cat # Qty 442 Level C x 20 ml Liquichek Urine Toxicology Control, Level C4 A human urine control containing drugs of abuse at elevated levels for monitoring confirmatory testing methods. 3 year shelf life at 2 8ºC 30 day open-vial stability at 2 8ºC 443 Level C x 20 ml Designed for use with 2,000 ng/ml Opiate, 250 ng/ml Amphetamine and 100 ng/ml Benzoylecgonine cutoff concentrations. MiniPaks also available Cat # Liquichek Urine Toxicology Control, Level C4 Quantity 444 Level C x 20 ml Refer to the package insert of currently available lots for specific analyte and stability claims. 100 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

104 Toxicology Drugs-of-Abuse Controls Which Confirmatory Controls are Right for You? Negative Level C1 Level C2 Level C2 Low Opiate Level C3 Level C3 Low Opiate Level C4 0 LOQ -25% Confirmatory +25% Elevated Cutoff Liquichek Urine Toxicology Confirmatory Control Gravimetric Reference Values (ng/ml) Level C1 Level C2 Low Opiate Level C3 Low Opiate Level C2 Level C3 Level C4 Catalog Number Amphetamines d-amphetamine d-methamphetamine , 4-Methylenedioxymethamphetamine (MDMA) , 4-Methylenedioxyamphetamine (MDA) , 4-Methylenedioxy-N-ethylamphetamine (MDEA) Barbiturates Amobarbitital ,200 Butalbital ,200 Pentobarbital ,200 Phenobarbitital ,200 Secobarbital ,200 Benzodiazepines Alpha-Hydroxyalprazolam ,000 Nordiazepam ,000 Oxazepam Cannabinoids 11-Nor-Δ-9-THC-9-COOH Cocaine Benzoylecgonine Ethanol (mg/dl) Lysergic Acid Diethylamide (LSD) Methadone Methadone ,000 EDDP (Methadone Metabolite) Methaqualone ,000 Opiates 6-Monoacetylmorphine Codeine ,500 2,500 4,000 Morphine-3-β-d-Glucuronide ,500 2,500 4,000 Phencyclidine (PCP) Propoxyphenes Norpropoxyphene ,000 Propoxyphene ,000 +Analyte present, no claims are made regarding performance or stability. Refer to the package insert for performance and stability claims. Visit myeinserts.com to view product inserts online, anytime

105 Toxicology Drugs-of-Abuse Controls Liquichek Opiate Control A human urine control containing eight drugs or drug metabolites in two levels, at concentrations above and below most assay cutoffs. This control has been tested by GC/MS, LC/MS/MS and other methods to confirm the recovery of drug quantities added, with representative values provided for screening and confirmatory methods. Human urine 3 year shelf-life at -20ºC to -70ºC 30 day open-vial stability at 2 8ºC Available in two levels, containing drugs or drug metabolites at concentrations above and below most assay cutoffs Representative values provided for screening and confirmatory methods Gravimetric Reference Values Analyte (ng/ml) Level 1 Level 2 Catalog Number Monoacetylmorphine (6-MAM, Heroin Metabolite) Buprenorphine 5 15 EDDP (Methadone Metabolite) Fentanyl Meperidine* Methadone Oxycodone Tramadol* *International use only. Not for diagnostic use in the United States. Refer to the package insert for performance and stability claims Cat # Liquichek Opiate Control Quantity 416 Level x 5 ml 417 Level x 5 ml 415X Bilevel MiniPak (1 of each level) x 5 ml 102 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

106 Toxicology Specialty Controls Bio-Rad Controls for Lead, Alcohol, Environmental Toxins and Other Specialty Tests Our Specialty Controls are designed for use with a variety of moderate to high complexity, analytical methods Mass Spectrometry, ICP, HPLC, LC, GC, AA and more. For laboratories that perform specialty testing on samples for lead, alcohol and other environmental or occupational toxins, Bio-Rad offers several Specialty Controls. Reduce the exposure risk to technologists analyzing samples for heavy metals (arsenic, cadmium, mercury and others) and save time by using Bio-Rad controls to monitor performance and report reliable results on all your toxicology samples. Bio-Rad offers QC solutions for the unique challenges of specialty toxicology testing, such as drug-free baseline serum or a control suitable for the special needs of analytical methods. Other specialty controls are available for use with volatile compounds, plasma catecholamines and bone markers. Liquichek Whole Blood Volatiles Control An assayed, liquid toxicology control for monitoring the precision of volatile compounds. Available in 2 levels. Liquid, ready to use Human blood based 2 year shelf life at 2 8 C 5 day open-vial stability at 2 8 C Acetone Ethanol Isopropanol (Isopropyl Alcohol) Lead Methanol (Methyl Alcohol) Refer to the package insert of currently available lots for specific analyte and stability claims. Product may be temporarily unavailable. Please contact your Bio-Rad representative for availability. Cat # Liquichek Whole Blood Volatiles Control Quantity 305 Bilevel (6 of each level) x 3 ml 305X Bilevel MiniPak (1 of each level) x 3 ml Visit myeinserts.com to view product inserts online, anytime

107 Toxicology Specialty Controls Liquichek Serum Volatiles Control A bilevel, liquid control with assayed values for the most widely measured volatile compounds. Liquid, ready to use Human serum based 3 year shelf life at 2 8 C 10 day open-vial stability at 2 8 C Acetone Ethanol Ethylene Glycol Isopropanol (Isopropyl Alcohol) Methanol (Methyl Alcohol) Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek Serum Volatiles Control Quantity 383 Level x 5 ml 384 Level x 5 ml 385X Bilevel MiniPak (1 of each level) x 5 ml Lyphochek Urine Metals Control A bilevel, human urine control designed for toxicological environmental and industrial testing. Human urine Contains critical trace elements, heavy metals and organic metabolites 3 year shelf life at 2 8 C 5 day reconstituted stability at 2 8 C Use with Atomic Absorption (AA), GC-MS, HPLC and ICP 5-Aminolevulinic Acid (ALA) Aluminum Antimony Arsenic Cadmium Chromium Cobalt Copper Fluoride Hippuric Acid Lead Magnesium Refer to the package insert of currently available lots for specific analyte and stability claims. Mandelic Acid Manganese Mercury Nickel Pentachlorophenol Phenol Phenylglyoxylic Acid Selenium Thallium Trichloroacetic Acid Zinc Cat # Lyphochek Urine Metals Control Qty Cat # Qty 400 Level x 25 ml 405 Level x 25 ml Lyphochek Whole Blood Metals Control Contains the major heavy metals of toxicological and environmental significance for whole blood analysis. Human whole blood based 3 year shelf life at 2 8 C 14 day reconstituted stability at 2 8ºC Assayed Lead values for AA, ASV, ICP-MS and IDMS Arsenic Cadmium Lead Mercury Thallium Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Whole Blood Metals Control Qty Cat # Qty 527 Level x 2 ml 528 Level x 2 ml 529 Level x 2 ml 528X Trilevel MiniPak (1 of each level)... 3 x 2 ml 104 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

108 Toxicology Specialty Controls Lyphochek Whole Blood Control Designed to monitor the precision of red cell folate and lead in whole blood assays. This control is assayed at three critical levels. Human whole blood based 3 year shelf life at 2 8 C Lead assay values for Atomic Absorption (AA), Anodic Stripping Voltammetry (ASV) and Isotope Dilution Mass Spectroscopy (IDMS) Lead Red Cell Folate Serotonin* *No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Whole Blood Control Quantity 561 Level x 2 ml 562 Level x 2 ml 563 Level x 2 ml 560X Trilevel MiniPak (1 of each level)... 3 x 2 ml Lyphochek Benzo/TCA Control Set A An ideal control for monitoring the precision of HPLC methods for identification and quantitation of benzodiazepines and tricyclic antidepressant drugs. Human serum based 3 year shelf life at 2 8 C 30 day reconstituted stability at 2 8 C Amitriptyline Benzodiazepines Chlordiazepoxide Desalkylflurazepam Desipramine Diazepam Doxepin Imipramine Nordiazepam Nordoxepin Nortriptyline Oxazepam Tricyclic Antidepressants (TCA) Screen Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Benzo/TCA Control Set A Quantity 661 Level x 5 ml 662 Level x 5 ml 660X Bilevel MiniPak (1 of each level) x 5 ml Lyphochek Benzo/TCA Control Set B An ideal control for monitoring the precision of HPLC methods for identification and quantitation of benzodiazepines and antidepressant drugs. Human serum based 3 year shelf life at 2 8 C 14 day reconstituted stability at 2 8 C Alprazolam Clomipramine Norclomipramine Trazodone Clonazepam has been added to this product as a service to laboratories that wish to investigate this analyte. No claims are made regarding performance or stability. Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Lyphochek Benzo/TCA Control Set B Quantity 663 Level x 5 ml 664 Level x 5 ml 665X Bilevel MiniPak (1 of each level) x 5 ml Visit myeinserts.com to view product inserts online, anytime

109 Toxicology Specialty Controls Lyphochek Drug Free Serum A lyophilized, serum control tested negative for more than 60 therapeutic drugs and illicit compounds. Drug-free baseline reference includes HPLC analysis and other methods For use as a negative control 3 year shelf life at 2 8 C 10 day reconstituted stability at 2 8 C Acetaminophen Alprazolam Amikacin Amitriptyline Amphetamines Caffeine Cannabinoids Carbamazepine Chloramphenicol Chlordiazepoxide Cimetidine Clomipramine Clonazepam Cocaine Codeine Cyclosporine Desalkylflurazepam Desipramine Desmethyldoxepin Diazepam Digitoxin Digoxin Disopyramide* Doxepin Ethosuximide Flecainide Gentamicin Glutethimide Haloperidol Hydromorphone Ibuprofen Imipramine Lidocaine Lithium Meperidine Methadone Methamphetamine Methaqualone Methotrexate Methyprylon Morphine N-Acetylprocainamide (NAPA) Nicotine Norclomipramine Nordiazepam Nordoxepin Nortriptyline Oxazepam Phencyclidine (PCP) Phenobarbital Phenothiazines Phenytoin Primidone Procainamide Propoxyphene Propranolol Pyrilamine Quinidine Quinine Salicylate Secobarbital Theophylline Tobramycin Trazodone Valproic Acid Vancomycin *No claim is made for expected values or stability. Refer to the package insert of currently available lots for specific analyte and stability claims, detection limits of methods used, and supported instruments. Cat # Lyphochek Drug Free Serum Quantity 456 Single Level x 10 ml 456X MiniPak x 10 ml 106 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

110 Molecular Controls AmpliTrol CT/GC AmpliPROBE CT/GC AmpliClear AmpliTrol HPV AmpliTrol III

111 Molecular Controls Regular Use of Bio-Rad Molecular Controls Could Save You Time and Money Bio-Rad can help you identify an appropriate, easy to use molecular control for your HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, HIV, Hepatitis B and C test procedures. Molecular testing requires uncompromising adherence to good technique. Your quality control standards should play an important part in the consistency and reliability of your reported molecular results. Because the components of molecular testing extraction, amplification and detection may involve highly complex technologies, your quality control practices should be exercised as conscientiously as they are elsewhere in the laboratory. Regular use of a Bio-Rad molecular control may facilitate early detection of a shift or trend and could ultimately prove cost effective if the downward trend in performance is caught before test failure. Few laboratories have the resources or desire to make their own molecular control materials. Bio-Rad can help identify an appropriate, easy to use molecular control for your Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), HPV, HIV, Hepatitis B and C test procedures. 108 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

112 Molecular Controls AmpliTrol CT/GC For use as an unassayed quality control in nucleic acid amplification assays detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Chlamydia trachomatis Neisseria gonorrhoeae Refer to the package insert for performance and stability claims. Cat # AmpliTrol CT/GC Quantity Single Level/Dropper Bottle... 1 x 5 ml AmpliPROBE CT/GC For use as an unassayed quality control in the Gen-Probe APTIMA Combo 2 test system for detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Chlamydia trachomatis Neisseria gonorrhoeae Refer to the package insert for performance and stability claims. Cat # AmpliPROBE CT/GC Quantity Single Level/Dropper Bottle... 1 x 5 ml AmpliClear For use as an unassayed, non-reactive quality control in nucleic acid amplification assays detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Non-reactive for: Chlamydia trachomatis Neisseria gonorrhoeae Refer to the package insert for performance and stability claims. Cat # AmpliClear Quantity Single Level/Dropper Bottle... 1 x 5 ml Visit myeinserts.com to view product inserts online, anytime

113 Molecular Controls AmpliTrol HPV For use as an unassayed quality control in the Digene Hybrid Capture 2 high-risk HPV DNA test system detecting Human papillomavirus. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Human Papillomavirus (HPV) Refer to the package insert for performance and stability claims. Cat # AmpliTrol HPV Quantity Single Level/Dropper Bottle... 1 x 5 ml AmpliTrol III For use as a positive, unassayed control with qualitative assay procedures for the detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) nucleic acids in human serum, or plasma from donations of whole blood and blood components for transfusion. Human serum based 60 day open-vial stability at 2 8ºC 10 month shelf life at 2 8 C Multi-analyte control Liquid convenience Controls the entire process, including nucleic acid extraction and amplification steps HBV HCV HIV-1 Refer to the package insert for performance and stability claims. Cat # AmpliTrol III Quantity Single Level/Vial x 1 ml 110 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

114 Infectious Disease Controls Hepatitis & Retrovirus VIROTROL I Assayed VIROTROL I-C Assayed VIROTROL I-E Assayed VIROTROL I-F VIROTROL II Assayed VIROTROL II-A Assayed VIROTROL II-B VIROTROL III VIROTROL IV VIROCLEAR VIROTROL HIV-1 Ag VIROTROL HIV VIROTROL HAV-IgM VIROTROL HBc-IgM VIROTROL HBeAg Congenital/Pediatric Diseases VIROTROL ToRCH VIROTROL ToRCH-M VIROCLEAR ToRCH Liquichek ToRCH Plus Control Liquichek ToRCH Plus IgM Control VIROTROL MuMZ VIROCLEAR MuMZ Sexually Transmitted Diseases VIROTROL Syphilis Total VIROTROL Syphilis LR-A VIROTROL Syphilis LR-B VIROTROL RPR Panel Specialty Infectious Diseases VIROTROL EBV VIROCLEAR EBV PneumoTrol PyloriTrol VIROTROL Chagas VIROTROL Lyme VIROTROL WNV

115 Infectious Disease Controls Infectious Disease Multi-analyte Controls When You Want the Benefits of Consolidation Our advantages only begin with consolidation our liquid controls are ready-to-use and have an extended shelf-life from 18 to 36 months at refrigerated (not frozen) temperatures. With a comprehensive selection of controls to monitor HIV, Hepatitis, ToRCH, and other assays Bio-Rad has a superior solution for quality programs that include infectious disease testing. You don t have to settle for a single analyte control when you need to test for multiple analytes. We offer several multi-analyte controls to provide customers the benefits of test consolidation on a variety of analytical platforms and methodologies. Our advantages only begin with consolidation you ll also find liquid controls are ready-to-use and that our controls with an extended shelf-life at refrigerated (not frozen) temperatures may reduce your need to value assign new controls throughout the year. Last but not least, customers have expressed appreciation for the performance of VIROTROL HIV-1 Ag Control with their HIV combination tests, or 4th generation HIV assays. In short, we think laboratories will see savings benefits in time, labor and cost effective storage options when they use these Bio-Rad Controls. VIROTROL I For use as an unassayed quality control with assays detecting Hepatitis B Surface Antigen, antibodies to Human Immunodeficiency Virus Type 1, antibodies to Human T-Lymphotropic Virus Type I, antibodies to Hepatitis B core Antigen, antibodies to Hepatitis C Virus and antibodies to Cytomegalovirus. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Available in multiple configurations and fill sizes Anti-CMV Anti-HBc Anti-HCV Anti-HIV-1 Anti-HTLV-I HBsAg Refer to the package insert for performance and stability claims. Cat # VIROTROL I Qty Cat # Qty Single Level/Dropper Bottle... 1 x 5 ml 00100A Single Level/Dropper Bottle... 1 x 5 ml 00100B Single Level/Dropper Bottle... 1 x 5 ml 00100C Single Level/Dropper Bottle... 1 x 5 ml 00100E Single Level/Dropper Bottle... 1 x 5 ml 00100F Single Level/Dropper Bottle... 1 x 5 ml 00100G Single Level/Dropper Bottle... 1 x 5 ml 00100H Single Level/Dropper Bottle... 1 x 5 ml Single Level/Tube x 4 ml 00101B Single Level/Tube x 4 ml 00101C Single Level/Tube x 4 ml 00101D Single Level/Tube x 4 ml 00101E Single Level/Tube x 4 ml 00101F Single Level/Tube x 4 ml 00101G Single Level/Tube x 4 ml Single Level/Dropper Bottle... 2 x 20 ml 00102B Single Level/Dropper Bottle... 2 x 20 ml 00102C Single Level/Dropper Bottle... 2 x 20 ml 112 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

116 Hepatitis & Retrovirus Infectious Disease Controls Assayed VIROTROL I-C Suitable for use with Siemens ADVIA Centaur Series Assayed VIROTROL I-E Suitable for use with Roche Elecsys /MODULAR Systems Assayed VIROTROL I-F Suitable for use with ARCHITECT Systems For use as assayed quality controls with methods detecting Hepatitis B surface Antigen, antibodies to Human Immunodeficiency Virus Type 1, antibodies to Hepatitis C Virus, and antibodies to Hepatitis B core Antigen. Human serum based Values provided for popular automated methods 3 year shelf life at 2 8 C 60 day open-vial stability at 2 8 C Anti-CMV* Anti-HBc Anti-HCV Anti-HIV-1 Anti-HTLV-I* HBsAg *Values not provided. Refer to the package insert of currently available lots for specific analyte and stabillity claims. Available outside the United States only. Cat # Quality Control Quantity Assayed VIROTROL I-C, Single Level/Dropper Bottle x 5 ml Assayed VIROTROL I-E, Single Level/Dropper Bottle x 5 ml Assayed VIROTROL I-F, Single Level/Dropper Bottle x 5 ml VIROTROL II For use as an unassayed quality control with assays detecting antibodies to Hepatitis B surface Antigen and antibodies to Hepatitis A Virus. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Available in multiple configurations and fill sizes Anti-HAV Anti-HBs Refer to the package insert for performance and stability claims. Cat # VIROTROL II Qty Cat # Qty Single Level/Dropper Bottle... 1 x 5 ml 00104A Single Level/Dropper Bottle... 1 x 5 ml 00104B Single Level/Dropper Bottle... 1 x 5 ml Single Level/Tube x 4 ml 00115A Single Level/Tube x 4 ml 00115B Single Level/Tube x 4 ml Assayed VIROTROL II-A For use with the Abbott AxSYM and Ortho VITROS ECi Assayed VIROTROL II-B For use with Abbott ARCHITECT Systems, Siemens ADVIA Centaur Series, Roche Elecsys /MODULAR Systems, and Siemens BEP III/BEP 2000/Enzygnost For use as assayed quality controls with assays detecting antibodies to Hepatitis B surface Antigen and total antibodies to Hepatitis A Virus. Anti-HAV Anti-HBs Refer to the package insert for performance and stability claims. Human serum based Multi-analyte control allows for product consolidation 3 year shelf life at 2-8ºC 60 day open-vial stability at 2 8ºC Available outside the United States only. Cat # Quality Control Quantity Assayed VIROTROL II-A, Single Level/Dropper Bottle... 1 x 5 ml Assayed VIROTROL II-B, Single Level/Dropper Bottle... 1 x 5 ml Visit myeinserts.com to view product inserts online, anytime

117 Infectious Disease Controls Hepatitis & Retrovirus VIROTROL III For use as an unassayed quality control with assays detecting IgM antibodies to Hepatitis B core Antigen, IgM antibodies to Hepatitis A Virus, and total antibodies to Hepatitis A Virus. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Anti-HAV HAV-IgM HBc-IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL III Qty Single Level/Dropper Bottle... 1 x 5 ml 00110A Single Level/Dropper Bottle... 1 x 5 ml Cat # 00110B 00110C Qty Single Level/Dropper Bottle... 1 x 5 ml Single Level/Dropper Bottle... 1 x 5 ml VIROTROL IV For use as an unassayed quality control with assays detecting antibodies to Hepatitis B envelope Antigen. Human serum based 18 month shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Anti-HBe Refer to the package insert for performance and stability claims. Cat # VIROTROL IV Quantity Single Level/Dropper Bottle... 1 x 5 ml VIROCLEAR For use as an unassayed, non-reactive quality control. Non-reactive for commonly tested analytes for Hepatitis, Retrovirus, Syphilis and antibodies to CMV. Human serum based Non-reactive for multiple analytes to allow for product consolidation 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Available in multiple configurations and fill sizes Non-reactive for: Anti-CMV Anti-HAV Anti-HBc Anti-HBe Anti-HBs Anti-HCV Anti-HDV Anti-HIV-1 Anti-HIV-2 Anti-HTLV-I Anti-HTLV-II HAV-IgM HBc-IgM HBeAg HBsAg HIV-1 Ag* Non-treponemal Antibodies (Syphilitic Reagin) Treponema pallidum (Syphilis) IgG Treponema pallidum (Syphilis) IgM *Available in the US only. Refer to the package insert for performance and stability claims. Cat # VIROCLEAR Quantity Single Level/Dropper Bottle... 1 x 5 ml Single Level/Dropper Bottle... 2 x 20 ml Single Level/Tube x 4 ml 114 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

118 Hepatitis & Retrovirus Infectious Disease Controls VIROTROL HIV-1 Ag For use as an unassayed quality control with assays detecting Human Immunodeficiency Virus Type 1 antigens. Human serum based 18 month shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte HIV-1 Ag Refer to the package insert for performance and stability claims. Cat # VIROTROL HIV-1 Ag Quantity Single Level/Dropper Bottle... 1 x 5 ml 00108A Single Level/Dropper Bottle... 1 x 5 ml 00108B Single Level/Dropper Bottle... 1 x 5 ml VIROTROL HIV-2 For use as an unassayed quality control with assays detecting antibodies to Human Immunodeficiency Virus Type 2. Human serum based 18 month shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Anti-HIV-2 Refer to the package insert for performance and stability claims. Cat # VIROTROL HIV-2 Quantity Single Level/Dropper Bottle... 1 x 5 ml 00105A Single Level/Dropper Bottle... 1 x 5 ml 00105B Single Level/Dropper Bottle... 1 x 5 ml 00105C Single Level/Dropper Bottle... 1 x 5 ml VIROTROL HAV-IgM For use as an unassayed quality control with assays detecting Immunoglobulin M (IgM) antibodies to Hepatitis A Virus. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte HAV-IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL HAV-IgM Quantity Single Level/Dropper Bottle... 1 x 5 ml 00142A Single Level/Dropper Bottle... 1 x 5 ml 00142B Single Level/Dropper Bottle... 1 x 5 ml Visit myeinserts.com to view product inserts online, anytime

119 Infectious Disease Controls Hepatitis & Retrovirus VIROTROL HBc-IgM For use as an unassayed quality control with assays detecting Immunoglobulin M (IgM) antibodies to Hepatitis B core Antigen. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte HBc-IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL HBc-IgM Quantity Single Level/Dropper Bottle... 1 x 5 ml VIROTROL HBeAg For use as an unassayed quality control with assays detecting Hepatitis B envelope Antigen. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte HBeAg Refer to the package insert for performance and stability claims. Cat # VIROTROL HBeAg Quantity Single Level/Dropper Bottle... 1 x 5 ml 116 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

120 Congenital/Pediatric Diseases Infectious Disease Controls VIROTROL ToRCH For use as an unassayed quality control with assays detecting IgG antibodies to Toxoplasma gondii, IgG antibodies to Rubella Virus, IgG antibodies to Cytomegalovirus and IgG antibodies to Herpes Simplex Virus Types 1 and 2. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Toxoplasma gondii IgG Cytomegalovirus (CMV) IgG Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 2 (HSV-2) IgG Rubella Virus IgG Refer to the package insert for performance and stability claims. Cat # VIROTROL ToRCH Quantity Single Level/Dropper Bottle... 1 x 5 ml VIROTROL ToRCH-M For use as an unassayed quality control with assays detecting IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Rubella Virus, IgG and IgM antibodies to Cytomegalovirus, and IgG antibodies to Herpes Simplex Virus Types 1 and 2. Human serum based 18 month shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Toxoplasma gondii IgG Toxoplasma gondii IgM Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 2 (HSV-2) IgG Rubella Virus IgG Rubella Virus IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL ToRCH-M Quantity Single Level/Dropper Bottle... 1 x 5 ml 00117B Single Level/Dropper Bottle... 1 x 5 ml VIROCLEAR ToRCH For use as an unassayed, non-reactive quality control with assays detecting IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Rubella Virus, IgG and IgM antibodies to Cytomegalovirus, and IgG and IgM antibodies to Herpes Simplex Virus Types 1 and 2. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Non-reactive for: Toxoplasma gondii IgG Toxoplasma gondii IgM Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgG Herpes Simplex Virus Type 2 (HSV-2) IgM Rubella Virus IgG Rubella Virus IgM Refer to the package insert for performance and stability claims. Cat # VIROCLEAR ToRCH Quantity Single Level/Dropper Bottle... 1 x 5 ml Visit myeinserts.com to view product inserts online, anytime

121 Infectious Disease Controls Congenital/Pediatric Diseases Liquichek ToRCH Plus Control A bilevel, liquid control used to monitor the performance of the most widely used serology instruments and methods. A positive and a negative control allow you to monitor the performance of your test system at the critical decision making levels. Liquid, human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Positive and negative controls packaged separately Helicobacter pylori IgG Toxoplasma gondii IgG Treponema pallidum (Syphilis) IgG Cytomegalovirus (CMV) IgG Epstein-Barr Virus (VCA) IgG Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 2 (HSV-2) IgG Rubella Virus IgG Syphilis RPR Varicella Zoster Virus (VZV) IgG Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek ToRCH Plus Control Qty Cat # *Assayed control available outside the United States only. Qty 239 Positive x 3 ml 239X Positive MiniPak... 1 x 3 ml 227 Positive, Assayed* x 3 ml 227X Positive, Assayed MiniPak* x 3 ml 228 Negative x 3 ml 228X Negative MiniPak... 1 x 3 m Liquichek ToRCH Plus IgM Control A bilevel, unassayed liquid control used to monitor the performance of immunoassay methods to detect IgM antibodies to ToRCH panel analytes. Liquid, human serum based Positive and negative controls packaged separately 3 year shelf life at -20ºC to -70ºC 60 day open-vial stability at 2 8ºC Toxoplasma gondii IgM Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgM Rubella Virus IgM Refer to the package insert of currently available lots for specific analyte and stability claims. Cat # Liquichek ToRCH Plus IgM Control Qty Cat # Qty 229 Positive x 2 ml 229PX Positive MiniPak... 1 x 2 ml 230 Negative x 2 ml 230NX Negative MiniPak... 1 x 2 ml VIROTROL MuMZ and VIROCLEAR MuMZ For use as unassayed quality controls with assays detecting IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles) and IgG antibodies to Varicella Zoster Virus. Use VIROTROL MuMZ as a reactive control and VIROCLEAR MuMZ as a non-reactive control for the analytes listed at right. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Mumps Virus IgG Rubeola Virus (Measles) IgG Varicella Zoster Virus (VZV) IgG Refer to the package insert for performance and stability claims. Cat # Quality Control Quantity VIROTROL MuMZ, Single Level/Dropper Bottle x 5 ml VIROCLEAR MuMZ, Single Level/Dropper Bottle... 1 x 5 ml 118 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

122 Sexually Transmitted Diseases Infectious Disease Controls VIROTROL Syphilis Total For use as an unassayed quality control with assays detecting Immunoglobulin G and Immunoglobulin M antibodies to Treponema pallidum and non-treponemal antibodies. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Treponema pallidum (Syphilis) IgM Treponema pallidum (Syphilis) IgG Non-treponemal Antibodies (Syphilitic Reagin) Refer to the package insert for performance and stability claims. Cat # VIROTROL Syphilis Total Quantity Single Level/Dropper Bottle... 1 x 5 ml VIROTROL Syphilis LR-A and VIROTROL Syphilis LR-B For use as a low reactive (LR), unassayed quality control with assays detecting total antibodies to Treponema pallidum. Human serum based 3 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Treponema pallidum (Syphilis) Refer to the package insert for performance and stability claims. Cat # Quality Control Quantity VIROTROL Syphilis LR-A, Single Level/Tube x 4 ml 00171X VIROTROL Syphilis LR-A, Single Level/Tube x 4 ml VIROTROL Syphilis LR-B, Single Level/Tube... 5 x 4 ml 00172X VIROTROL Syphilis LR-B, Single Level/Tube... 1 x 4 ml VIROTROL RPR Panel For use as an unassayed quality control with assays used for the qualitative detection of non-treponemal antibodies. The VIROTROL RPR Panel consists of one non-reactive member, one minimally reactive member, and one moderately to highly reactive titerable member. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Non-treponemal Antibodies (Syphilitic Reagin) Refer to the package insert for performance and stability claims. Cat # VIROTROL RPR Panel Quantity Three Levels/Vial....3 x 1.5 ml Visit myeinserts.com to view product inserts online, anytime

123 Infectious Disease Controls Specialty Infectious Disease VIROTROL EBV For use as an unassayed quality control with assays detecting IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr virus and IgG antibodies to Epstein-Barr virus nuclear antigen. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC EBNA IgG Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL EBV Quantity Single Level/Dropper Bottle... 1 x 5 ml 00128A Single Level/Dropper Bottle... 1 x 5 ml 00128B Single Level/Dropper Bottle... 1 x 5 ml VIROCLEAR EBV For use as an unassayed, non-reactive quality control with assays detecting IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr virus, IgG antibodies to early antigen and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr virus. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Non-reactive for: EBNA IgG EBV EA IgG Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM Refer to the package insert for performance and stability claims. Cat # VIROCLEAR EBV Quantity Single Level/Dropper Bottle... 1 x 5 ml 120 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

124 Specialty Infectious Disease Infectious Disease Controls PneumoTrol For use as an unassayed quality control with assays detecting IgG and IgM antibodies to Mycoplasma pneumoniae and IgG antibodies to Chlamydia species. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Chlamydia trachomatis IgG Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM Refer to the package insert for performance and stability claims. Cat # PneumoTrol Quantity Single Level/Dropper Bottle... 1 x 5 ml PyloriTrol For use as an unassayed quality control with assays detecting IgG antibodies to Helicobacter pylori. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Helicobacter pylori IgG Refer to the package insert for performance and stability claims. Cat # PyloriTrol Quantity Single Level/Dropper Bottle... 1 x 5 ml Visit myeinserts.com to view product inserts online, anytime

125 Infectious Disease Controls Specialty Infectious Disease VIROTROL Chagas An unassayed, reactive quality control for use with assays for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or plasma. T. cruzi is characteristically associated with Chagas disease. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Trypanosoma cruzi (T. cruzi) Refer to the package insert for performance and stability claims. Cat # VIROTROL Chagas Quantity Single Level/Tube x 4 ml 00125X Single Level/Tube x 4 ml VIROTROL Lyme For use as an unassayed quality control with assays detecting Immunoglobulin G antibodies to Borrelia burgdorferi. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC Analyte Borrelia burgdorferi IgG Refer to the package insert for performance and stability claims. Cat # VIROTROL Lyme Quantity Single Level/Dropper Bottle... 1 x 5 ml VIROTROL WNV An unassayed quality control for use with assays detecting Immunoglobulin G and Immunoglobulin M antibodies to West Nile Virus. Human serum based 2 year shelf life at 2 8ºC 60 day open-vial stability at 2 8ºC West Nile Virus IgG West Nile Virus IgM Refer to the package insert for performance and stability claims. Cat # VIROTROL WNV Quantity Single Level/Dropper Bottle... 1 x 5 ml 122 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

126 Accessories, Safety and Labeling Product Accessories Chemical Hazard Communication CE Marking and Labeling Symbols

127 Product Accessories Dispenser Tips for Screw Caps An accessory for control bottles with a screw cap type closer. These plastic tops allow the glass vial to be used as a dropper bottle to conveniently dispense the control in drops. Easy and convenient to use Dispense in drops Cat # Product Accessory Quantity Dispenser Tips for Screw Caps /Package Dispenser Tips for Crimp Seals An accessory for control bottles with a metal crimp seal and stopper. These plastic tops allow the glass vial to be used as a dropper bottle to conveniently dispense the control in drops. Easy and convenient to use Dispense in drops Cat # Product Accessory Quantity 588 Dispenser Tips for Crimp Seals /Package My einserts CD Quality control product inserts for Bio-Rad customers with limited or no access to the Internet. Cat # Languages Cat # Languages CDA CDB North & South America English, French, Portuguese & Spanish Europe Danish, English, Estonian, French, German, Greek, Italian, Lithuanian, Norwegian, Portuguese, Spanish & Swedish CDC CDD Eastern Europe Bulgarian, Croatian, Czech, English, French, Hungarian, Macedonian, Polish, Romanian, Russian, Slovak & Turkish Asia Pacific & Japan English, French, Indonesian, Japanese, Korean, Spanish, Thai, Simplified Chinese, Traditional Chinese & Vietnamese Unity Binders Keep your Unity Interlaboratory Program reports organized and readily available. 2 inch Capacity 3-Ring for Letter Size (8.5 x 11 inches) Monthly Tabs Provided To request these binders, please call your local Bio-Rad office. 124 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

128 Chemical Hazard Communication Chemical Hazard Communication Overview Product chemical hazard information is communicated through standard statements and hazard symbols on our labeling and Material Data Safety Sheets (MSDS)/ Safety Data Sheet (SDS). This information was previously based on the older system contained in the European Union Dangerous Substances Directive and the Dangerous Preparations Directive. This system is now being replaced with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), which is a new international system for chemical classification introducing new hazard symbols (pictograms) and labeling phrases. The key elements for the label under the GHS include: hazard pictograms a signal word either DANGER or WARNING where necessary hazard statements, indicating the nature and degree of the risks posed by the product precautionary statements, indicating how the product should be handled to minimize risks to the user (surrounding population and the general environment) A transition period for chemical hazard communication in product labeling will last until During this period our labelling and MSDS/SDS may reflect any of the information from the systems below. For a copy of an MSDS, or for environment or safety related information, contact the Bio-Rad office nearest you. You can find a complete list of Bio-Rad offices on the inside back cover of this catalog. MSDS and product inserts are also available online at (Note: European Union Regulation No. 1272/2008 on Classification, Labeling and Packaging (CLP) aligns the European Union system of classification, labeling and packaging chemical substances and mixtures to the GHS). Hazard information according to Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Health Hazards Environmental Hazards Skull & Crossbones Corrosion Environment Hazard Exclamation Mark Physical Hazards Health Hazard Corrosion Precautionary Statements P261 Avoid breathing dust/fumes/gas/mist/vapors/spray P270 Do not eat, drink or smoke when using this product P272 Contaminated work clothing should not be allowed out of the workplace. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. Hazard Statements H302 Harmful if swallowed. H314 Causes severe skin burns and eye damage. P302 + P352 IF ON SKIN: Wash with plenty of soap and water P305 + P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. H315 Causes skin irritation. P312 Call a POISON CENTER or doctor/physician if you feel unwell. H317 H319 H335 H336 H341 H411 H412 May cause an allergic skin reaction. Causes serious eye irritation. May cause respiratory irritation. May cause drowsiness or dizziness. Suspected of causing genetic defects. Toxic to acquatic life with long lasting effects. Harmful to acquatic life with long lasting effects. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P337 + P313 If eye irritation persists: Get medical advice/attention. P363 P391 Wash contaminated clothing before reuse. Collect spillage. P301 + P310 IF SWALLOWED: Immediately call a POISON Center or doctor/physician. Hazard information according to EU Dangerous Substances Directive and Dangerous Preparations Directive Pictogram Symbol Definition Harmful Irritant Toxic Xn Xi T Substances which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin. Non-corrosive substances which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation. Substances which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin. Risk Phrases R22 Harmful if swallowed. R25 Toxic if swallowed. R43 May cause sensitization by skin contact. R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Safety Phrases S24 Avoid contact with skin. S35 This material and its container must be disposed of in a safe way. S37 Wear suitable gloves. S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S61 Avoid release to the environment. Refer to special instructions/safety data sheets. Visit myeinserts.com to view product inserts online, anytime

129 CE Marking and Labeling Symbols CE Marking on Bio-Rad Products What is the CE Mark? The letters CE are an abbreviation of the French phrase Conformité européenne. The CE Mark on the Bio-Rad quality control products indicates the products have been designed and manufactured in an approved quality system and conform to all requirements of the In Vitro Diagnostic Directive (IVDD, 98/79/EC). The CE Mark allows products to be sold within the European Economic Area (EEA). The IVDD is one of many European directives intended to help ensure product conformity to certain standards across the EEA. The EEA consists of the European member states and several other European Free Trade Association members. The IVDD replaces multiple, and sometimes conflicting national standards or regulations in individual countries. How is CE Marking obtained? Companies must have their quality system certified by a European-based Notified Body in order to obtain CE Marking. A Notified Body is an organization authorized by the EEA to inspect facilities, processes, technical data, and/or test products to assess conformity to the appropriate standards. The quality system at Bio-Rad has been certified to be in conformance with the IVDD and the ISO quality system standards. A European Authorized Representative is also required for companies not based in the EEA. The Bio-Rad entity located in Marnes, France, is the Authorized Representative for Bio-Rad. What does CE Marking mean for Bio-Rad quality control products? In addition to allowing Bio-Rad to continue to sell products in the EEA, CE Marking also demonstrates how Bio-Rad continues its committment to quality. CE Marking is an extra measure of confidence that customers can have with Bio-Rad quality control products. Labeling Symbols European Conformity Use by YYYY-MM-DD (Expiration Date) Reconstitute With In Vitro Diagnostic Medical Device Manufacturer Catalog Number Temperature Limitation (Recommended product storage range) Mfd. For Manufactured for Lot Number Authorized Representative Consult instructions for Use (Refer to package insert) Caution, Consult Accompanying Documents Cycle Number Results Receipt Date Sample Number 126 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

130 Reference Bio-Rad Controls for Popular Instruments Chemistry and Immunoassay Instruments Infectious Disease Instruments Hematology Instruments Blood Gas Instruments Coagulation Instruments Bio-Rad Controls for Point of Care Testing Controls Listed for POCT Analyte Charts Control Analyte Index Molecular/Infectious Disease Controls Analyte Index Hematology Controls Analyte Index External Quality Assurance Services (EQAS ) Analyte Index

131 Controls for Popular Instruments Popular Chemistry & Immunoassay Instruments Values for these controls may be found in the applicable product insert or Unity Interlaboratory Program Reports. If your instrument model is not listed, please contact your nearest Bio-Rad office for current control information. Chemistry Immunoassay Cardiac Assessment Assayed Chemistry Assayed Multiqual Ethanol/Ammonia Unassayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Lipids Microalbumin Pediatric Manufacturer/ Instrument(s) Abbott Diagnostics Aeroset ARCHITECT Series AxSYM IMx TDx FLx Beckman Coulter Access Series/LX i/unicel Dxl AU Series CX /LX /UniCel DxC Series Immage BioMérieux VIDAS Bio-Rad Laboratories VARIANT II Turbo VARIANT II D-10 DiaSorin LIAISON Mitsubishi PATHFAST Ortho Clincal Diagnostics VITROS Series VITROS ECi Radiometer AQT90 FLEX Roche Diagnostics Cobas 6000 Series/COBAS INTEGRA COBAS MIRA Series Elecsys Systems Hitachi Systems MODULAR Systems Siemens ADVIA Series ADVIA Centaur Series BN Series Dimension Vista Dimension Series IMMULITE Series Stratus Viva /Syva V-Twin /Viva-E Tosoh AIA Series A1c G7 Other GC, GC-MS/GC-FID AA/AA, Graphite Furnace/AAS, Flame LC/LC-MS/HPLC ICP-MS Quantitative Urine Urine Chemistry Anemia Fertility Hypertension Markers Immunoassay Plus (Liquid & Lyophilized) Maternal Serum Specialty Immunoassay Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Cardiac Markers Plus Cardiac Markers Plus LT Cardiac Markers LT Cardiac Markers LT, Level Low CK/LD Isoenzyme Homocysteine 128 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

132 Controls for Popular Instruments TDM (Liquid & Lyophilized) Whole Blood Immunosuppressant (Liquid ) Whole Blood Immunosuppressant ( Lyophilized) Elevated CRP Immunology (Liquid) Immunology Plus (Lyophilized) Rheumatoid Factor Spinal Fluid Drug Free Serum Urine Bone Markers Serum Volatiles Whole Blood Volatiles Urine Metals Whole Blood Metals Benzo TCA (Set A & B) Whole Blood Control Diabetes (Liquid & Lyophilized) Hemoglobin A1C Linearity Hemoglobin A2 Urine Toxicology Therapeutic Drug Monitoring Immunology/Protein Toxicology-Specialty Diabetes/Hemoglobin Toxicology-Drugs of Abuse Manufacturer/ Instrument(s) Abbott Diagnostics Aeroset ARCHITECT Series AxSYM IMx TDx FLx Beckman Coulter Access Series/LX i/unicel Dxl AU Series CX /LX /UniCel DxC Series Immage BioMérieux VIDAS Bio-Rad Laboratories VARIANT II Turbo VARIANT II D-10 DiaSorin LIAISON Mitsubishi PATHFAST Ortho Clincal Diagnostics VITROS Series VITROS ECi Radiometer AQT90 FLEX Roche Diagnostics Cobas 6000 Series/COBAS INTEGRA COBAS MIRA Series Elecsys Systems Hitachi Systems MODULAR Systems Siemens ADVIA Series ADVIA Centaur Series BN Series Dimension Vista Dimension Series IMMULITE Series Stratus Viva /Syva V-Twin /Viva-E Tosoh AIA Series A1c G7 Other GC, GC-MS/GC-FID AA/AA, Graphite Furnace/AAS, Flame LC/LC-MS/HPLC ICP-MS Visit myeinserts.com to view product inserts online, anytime

133 Controls for Popular Instruments Popular Infectious Disease Instruments Please contact your Bio-Rad representative for additional details. Positive Controls Negative Controls Manufacturer/ Instrument(s) Abbott Diagnostics VIROTROL I VIROTROL II VIROTROL III VIROTROL IV VIROTROL HIV-1 Ag VIROTROL HIV-2 VIROTROL HAV-IgM VIROTROL HBeAg VIROTROL HBc-IgM VIROTROL Syphilis Total VIROTROL ToRCH VIROTROL ToRCH-M Liquichek ToRCH Plus (Positive) Liquichek ToRCH Plus IgM (Positive) VIROTROL Chagas VIROTROL MuMZ VIROTROL EBV PyloriTrol VIROTROL Lyme VIROCLEAR VIROCLEAR ToRCH Liquichek ToRCH Plus (Negative) Liquichek ToRCH Plus IgM (Negative) VIROCLEAR MuMZ Architect Series PRISM VIROCLEAR EBV Beckman Coulter Access Series/LX i/unicel Dxl BioMérieux VIDAS Bio-Rad Laboratories Evolis DiaSorin LIAISON ETI-MAX Systems Diesse Chorus Line Ortho Clincal Diagnostics VITROS Roche Diagnostics Elecsys Systems Siemens ADVIA Centaur Series IMMULITE Series The controls listed here include analyte(s) that may be appropriate for use on the test systems noted. Content is provided as a guide and for informational purposes only. Results and specific performance characteristics may vary with different manufacturers' test kits and assay procedures, different lots of the same test kit, and different lots of the control material. Please note that not all products may be available in all countries. Refer to the product insert for current product claims. 130 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

134 Controls for Popular Instruments Popular Hematology Instruments Please contact your Bio-Rad representative for additional details. Use for CBC and 5-Part Differential Parameters Use for CBC and 3-Part Differential Parameters Use for Reticulocyte Counts Manufacturer / Instrument(s) Use for CBC and Lymph Use for CBC Parameters Only Use for Manual Methods Hematology (A) Reticulocyte (A) Reticulocyte (A-I) Hematology (C) Reticulocyte (C) Hematology (S) Reticulocyte (S) Hematology (X) Reticulocyte (X) Hematology-16 Hematology-16T Abbott Diagnostics CELL-DYN 1700/1800 CELL-DYN 3000/ 3200 CELL-DYN 3500/3700 CELL-DYN 4000 CELL-DYN Ruby CELL-DYN Sapphire HORIBA ABX Diagnostics Micros 60 Beckman Coulter AcT DIFF/AcT DIFF2 AcT 8/AcT 10 AcT 5DIFF Gen-S LH 500/700 Series STKS /MAXM /HmX T-Series T890/T660/T540 ERMA PCE 210 FORTRESS CELLDIFF-3 MERCK MEDONIC CA 620 Mindray BC-1800/3000PLUS BC-2600/2800 BC-3000CT/3200/3000 PLUS NIHON KOHDEN CELL TRAC ALPHA MEK 6318 K/ 6410 K Siemens ADVIA 60 ADVIA 120/2120/2120i Sysmex KX-21 XE-2100/XE-5000 XT-2000i XT-1800i XS-1000i Other Hemoglobin Manual Method Platelet Hemocytometer Spun Hematocrit (Spun HCT) WBC Hemocytometer Visit myeinserts.com to view product inserts online, anytime

135 Controls for Popular Instruments Popular Blood Gas Instruments If your instrument model is not listed, please contact your nearest Bio-Rad office for current control information. Manufacturer/ Instrument(s) Blood Gas Blood Gas Plus E Blood Gas Plus EGL Blood Gas Plus Co-Oximeter (800 Series) ESCHWEILER Combiline Combisys II Ecolyte Ecosys II Modular Pro Instrumentation Laboratory 1610/ /1640/1650 GEM Premier Nova Biomedical phox Stat Profile 3 Stat Profile 1/2/3/4/5/7/9/10 Nova 8/Stat Profile Ultra Radiometer ABL 5 ABL 80 Series ABL 50/500/510/520 ABL 500 ABL 505 ABL 600/610/620 ABL 700 Series ABL 800 Series Roche Diagnostics AVL Compact Series AVL OMNI Cobas b 121 Siemens Series RAPIDLab Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

136 Controls for Popular Instruments Popular Coagulation Instruments If your instrument model is not listed, please contact your nearest Bio-Rad office for current control information. Manufacturer/ Instrument(s) Coagulation D-dimer Hemostasis Alere Triage Beckman Coulter Olympus AU BioMérieux VIDAS Diagnostica Stago STA Hemostasis System Instrumentation Laboratory ACL Advance/Futura ACL 8000 ELECTRA Mitsubishi PATHFAST Roche Diagnostics COBAS INTEGRA Hitachi Systems Siemens BCS /BCT Stratus CS Sysmex CA Series Trinity Biotech AMAX Series Visit myeinserts.com to view product inserts online, anytime

137 Controls for Point of Care Testing See pages 8-9 for more information about Bio-Rad Controls for Point of Care Testing. Suitable for POCT Chemistry Immunoassay Cardiac Assessment Toxicology-Drugs of Abuse Assayed Chemistry (Lyophilized) Assayed Multiqual Ethanol/Ammonia Lipids Manufacturer/ Instrument(s) Abaxis Piccolo Xpress Abbott CELL-DYN 1800 i-stat System MediSense Precision PCx /Precision Xtra Acon Mission Urinalysis Reagent Strips (Visual)/U120 Alere Biosite Triage Plus TCA Triage MeterPro Analyticon Combi Screen (Visual)/11 Sys Test Strips Combi Scan 100, 500 & XL Arkray Aution 9EB Stick/Aution Max AX-4280 Aution Max AX-4030 DiaScreen 10 (Visual)/50 Urine Chemistry Glucocard X-Meter Bayer Ascensia CONTOUR BD Clay Adams Autocrit Ultra 3 Centrifuge/READACRIT Centrifuge Beckman COULTER Ac T diff Coulter ICON hcg Bio-Rad in2it TOX/See Rapid Urine Drug Screen BTNX Rapid Response 11 Parameters Ultra (Visual)/Urine 120 Clarity Urocheck 10SG Urine Reagent Strips (Visual)/Urocheck 120 Eschweiler Combiline/Combysis II/Ecosys II Germain Laboratories Aimstrip 10-SG Urine Strip (Visual)/ CT-120 Hemocue Hb 201 DM/ Hb 201+ Plasma Low/Hb IND Urindstix 10LG Reagent Strips IL GEM Premier Iris vchem 10 SG/Visual i-sens CareSens II/CareSens N/CareSens POP Jant Pharmacal Accustrip URS 10/Visual (Catalog Nos. UA710A, UA870) LifeScan OneTouch Ultra/SureStep Flexx Macherey-Nagel Medi-Test Combi 10 SGL (Visual) Medi-Test Combi 11 with Uryxxon 200 Analyzers Medi-Test Uryxxon Stick 10 with Uryxxon 300/500/Relax Mitsubishi Chemical PATHFAST Immunoanalyzer Nova phox Biomedical Stat Profile 1/2/3/4/5/7/9/10 Stat Profile 3 Stat Profile Ultra StatStrip Xpress Glucose Polymedco Poly Stat hcg (HCG25) Quidel QuickVue One-Step hcg Combo/Urine Radiometer ABL 5 ABL 50/500/510/520 ABL 500 ABL 505 ABL 600/610/620 ABL 700 Series ABL 80 FLEX ABL 800 Series Microalbumin quantify quantify Plus Urinalysis Urine Chemistry Fertility Immunoassay Plus (Liquid & Lyophilized) Specialty Immunoassay Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Cardiac Markers Plus Cardiac Markers Plus LT Homocysteine Qualitative Urine Toxicology 134 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

138 Controls for Point of Care Testing TDM (Liquid ) TDM ( Lyophilized) Whole Blood Immunosuppressant (Lyophilized) Immunology (Liquid) Immunology Plus (Lyophilized) Blood Gas Blood Gas Plus E Blood Gas Plus EGL Blood Gas Plus CO-Oximeter (800 Series) Hematology (A) Hematology (X) Hematology-16 Hematology-16T D-dimer Diabetes (Liquid & Lyophilized) Hemoglobin A1C Linearity Hemoglobin A2 Meter Trax Therapeutic Drug Monitoring Immunology/Protein Blood Gas Hematology/Coagulation Diabetes/Hemoglobin Instrument(s)/Manufacturer Piccolo Xpress Abaxis CELL-DYN 1800 Abbott i-stat System MediSense Precision PCx /Precision Xtra Mission Urinalysis Reagent Strips (Visual)/U120 Acon Biosite Triage Plus TCA Alere Triage MeterPro Combi Screen (Visual)/11 Sys Test Strips Analyticon Combi Scan 100, 500 & XL Aution 9EB Stick/Aution Max AX-4280 Arkray Aution Max AX-4030 DiaScreen 10 (Visual)/50 Urine Chemistry Glucocard X-Meter Ascensia CONTOUR Bayer Autocrit Ultra 3 Centrifuge/READACRIT Centrifuge BD Clay Adams COULTER Ac T diff Beckman ICON hcg Coulter in2it Bio-Rad TOX/See Rapid Urine Drug Screen Rapid Response 11 Parameters Ultra (Visual)/Urine 120 BTNX Urocheck 10SG Urine Reagent Strips (Visual)/Urocheck120 Clarity Combiline/Combysis II/Ecosys II Eschweiler Aimstrip 10-SG Urine Strip (Visual)/ CT-120 Germain Laboratories Hb 201 DM/ Hb 201+ Hemocue Plasma Low/Hb Urindstix 10LG Reagent Strips IND GEM Premier IL vchem 10 SG/Visual Iris CareSens II/CareSens N/CareSens POP i-sens Accustrip URS 10/Visual (Catalog Nos. UA710A, UA870) Jant Pharmacal OneTouch Ultra/SureStep Flexx LifeScan Medi-Test Combi 10 SGL (Visual) Macherey-Nagel Medi-Test Combi 11 with Uryxxon 200 Analyzers Medi-Test Uryxxon Stick 10 with Uryxxon 300/500/Relax PATHFAST Immunoanalyzer Mitsubishi Chemical phox Nova Stat Profile 1/2/3/4/5/7/9/10 Biomedical Stat Profile 3 Stat Profile Ultra StatStrip Xpress Glucose Poly Stat hcg (HCG25) Polymedco QuickVue One-Step hcg Combo/Urine Quidel ABL 5 Radiometer ABL 50/500/510/520 ABL 500 ABL 505 ABL 600/610/620 ABL 700 Series ABL 80 FLEX ABL 800 Series Visit myeinserts.com to view product inserts online, anytime

139 Controls for Point of Care Testing See pages 8-9 for more information about Bio-Rad Controls for Point of Care Testing. Suitable for POCT Chemistry Immunoassay Cardiac Assessment Toxicology-Drugs of Abuse Assayed Chemistry (Lyophilized) Assayed Multiqual Ethanol/Ammonia Manufacturer/ Instrument(s) Roche ACCU-CHEK Advantage /ACCU-CHEK Aviva AVL Compact Series/AVL OMNI Chemstrip 101 Urine/ Chemstrip Criterion II Chemstrip Micral Test Strips Chemstrip Test Strips (10/UA) COBAS Integra 400 Plus COBAS Integra 800 Cobas b 121 Cobas c 111 Cobas u 411 Combur-Test Urine Test Strips (Visual) Elecsys 2010 Immunoassay Miditron M /Miditron Junior Urilux S Urisys 1100 /Urisys 1800 /Urisys 2400 Samsung LABGEO HC10 Sekisui (Genzyme) Diagnostics Osom hcg Urine Separation Technology HemataSTAT /HemataSTAT II Siemens Acetest CLINITEK Advantus /CLINITEK Atlas CLINITEK Status Analyzer/CLINITEK Status + CLINITEK 50/500 CLINITEK Microalbumin Reagent Strips Clinitest (5-Drop Method) Clinitest hcg Pregnancy Test DCA Vantage Ictotest /Multistix 10 SG Reagent Strips/Multistix PRO RAPIDLab 1200 Systems RAPIDLab 248 Systems RAPIDLab 348 Systems RAPIDLab 800 Series Stratus CS Acute Care Diagnostic System Stanbio Laboratory Uri-Check 10SG (Visual)/Uri-Trak StatSpin III, IV, V/StatSpin MP/CritSpin Sysmex XS-1000i Teco Diagnostics URS-10 (Visual)/Uritek TC-101/Uritek TC-720+ Thermo Fisher Scientific 10-SG Urinalysis Reagent Strips (Visual) Unipath Clearview HCG II Urit Medical Uritest 10G/11G Reagent Strips/Uritest-50/Uritest-500B YD Preg-Q Early Pregnancy Test Stick Uriscan Pro/Pro+/ProII/Optima/Optima+/Optima II Uriscan Reagent Strips (Visual)/Uriscan S-300 YSI Life Sciences YSI 2300 STAT Plus Glucose & Lactate Lipids Microalbumin quantify quantify Plus Urinalysis Urine Chemistry Fertility Immunoassay Plus (Liquid & Lyophilized) Specialty Immunoassay Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Cardiac Markers Plus Cardiac Markers Plus LT Homocysteine Qualitative Urine Toxicology 136 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

140 Controls for Point of Care Testing TDM (Liquid ) TDM ( Lyophilized) Whole Blood Immunosuppressant (Lyophilized) Immunology (Liquid) Immunology Plus (Lyophilized) Blood Gas Blood Gas Plus E Blood Gas Plus EGL Blood Gas Plus CO-Oximeter (800 Series) Hematology (A) Hematology (X) Hematology-16 Hematology-16T D-dimer Diabetes (Liquid & Lyophilized) Hemoglobin A1C Linearity Hemoglobin A2 Meter Trax Therapeutic Drug Monitoring Immunology/Protein Blood Gas Hematology/Coagulation Diabetes/Hemoglobin Instrument(s)/Manufacturer ACCU-CHEK Advantage /ACCU-CHEK Aviva Roche AVL Compact Series/AVL OMNI Chemstrip 101 Urine/ Chemstrip Criterion II Chemstrip Micral Test Strips Chemstrip Test Strips (10/UA) COBAS Integra 400 Plus COBAS Integra 800 cobas b 121 cobas c 111 analyzer cobas u 411 Combur-Test Urine Test Strips (Visual) Elecsys 2010 Immunoassay Miditron M /Miditron Junior Urilux S Analyzers Urisys 1100 /Urisys 1800 /Urisys 2400 LABGEO HC10 Samsung Osom Sekisui (Genzyme) hcg Urine Diagnostics HemataSTAT /HemataSTAT II Separation Technology Acetest Siemens CLINITEK Advantus /CLINITEK Atlas CLINITEK Status Analyzer/CLINITEK Status + CLINITEK 50/500 CLINITEK Microalbumin Reagent Strips Clinitest (5-Drop Method) Clinitest hcg Pregnancy Test DCA Vantage Ictotest /Multistix 10 SG Reagent Strips/Multistix PRO RAPIDLab 1200 Systems RAPIDLab 248 Systems RAPIDLab 348 Systems RAPIDLab 800 Series Stratus CS Acute Care Diagnostic System Uri-Check 10SG (Visual)/Uri-Trak Stanbio Laboratory III, IV, V/StatSpin MP/CritSpin StatSpin XS-1000i Sysmex URS-10 (Visual)/Uritek TC-101/Uritek TC-720+ Teco Diagnostics Thermo Fisher 10-SG Urinalysis Reagent Strips (Visual) Scientific Clearview HCG II Unipath Uritest 10G/11G Reagent Strips/Uritest-50/Uritest-500B Urit Medical Preg-Q Early Pregnancy Test Stick YD Uriscan Pro/Pro+/ProII/Optima/Optima+/Optima II Uriscan Reagent Strips (Visual)/Uriscan S-300 YSI 2300 STAT Plus Glucose & Lactate YSI Life Sciences Visit myeinserts.com to view product inserts online, anytime

141 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) 3-Methoxytyramine 5-Aminolevulinic Acid (ALA) 5-HIAA 6-Monoacetylmorphine (6-MAM; Heroin Metabolite) 11-Ketoetiocholanolone 11-Nor-Δ-9-THC-9-COOH 11-Ketoandrosterone 11-Deoxycortisol 11-β-Hydroxy-Androsterone 11-β-Hydroxy-Etiocholanolone 17-α-Hydroxyprogesterone 17-Hydroxycorticosteroids 17-Ketosteroids 17-Ketogenic Steroids 25-Hydroxy Vitamin D α-1-acid Glycoprotein α-1-antitrypsin α-1-globulin α-2-globulin α-2-macroglobulin αhbdh β-2-microglobulin β-globulin γ-globulin Acetaminophen Acetone Acid Phosphatase, Prostatic (PAP) Acid Phosphatase (Total) ACTH Activated Partial Thromboplastin Time (APTT) ADH ADNase B ALA Albumin Albumin-to-Creatinine Ratio Alcohol (Ethanol) Alcohol (Isopropanol) Alcohol (Methanol) Aldolase Aldosterone Alkaline Phosphatase (ALP) Alpha-Hydroxyalprazolam Alphafetoprotein (AFP) Alprazolam ALT/SGPT Aluminum Amikacin Amiodarone Amitriptyline Ammonia Amobarbital AMP (Cyclic) Amphetamines Amylase Amylase (Alpha) 138 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

142 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability 3-Methoxytyramine 5-Aminolevulinic Acid (ALA) 5-HIAA 6-Monoacetylmorphine (6-MAM; Heroin Metabolite) 11-Ketoetiocholanolone 11-Nor-Δ-9-THC-9-COOH 11-Ketoandrosterone 11-Deoxycortisol 11-β-Hydroxy-Androsterone 11-β-Hydroxy-Etiocholanolone 17-α-Hydroxyprogesterone 17-Hydroxycorticosteroids 17-Ketosteroids 17-Ketogenic Steroids 25-Hydroxy Vitamin D α-1-acid Glycoprotein α-1-antitrypsin α-1-globulin α-2-globulin α-2-macroglobulin αhbdh β-2-microglobulin β-globulin γ-globulin Acetaminophen Acetone Acid Phosphatase, Prostatic (PAP) Acid Phosphatase (Total) ACTH Activated Partial Thromboplastin Time (APTT) ADH ADNase B ALA Albumin Albumin-to-Creatinine Ratio Alcohol (Ethanol) Alcohol (Isopropanol) Alcohol (Methanol) Aldolase Aldosterone Alkaline Phosphatase (ALP) Alpha-Hydroxyalprazolam Alphafetoprotein (AFP) Alprazolam ALT/SGPT Aluminum Amikacin Amiodarone Amitriptyline Ammonia Amobarbital AMP (Cyclic) Amphetamines Amylase Amylase (Alpha) Visit myeinserts.com to view product inserts online, anytime

143 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Amylase (Pancreatic) ANA, Centromere Pattern ANA, Homogeneous Pattern ANA, Mitotic Spindle Pattern ANA, Nucleolar Pattern ANA, Speckled Pattern Androstenedione Androsterone Angiotensin I Anti-CCP Anti-CMV Anti-Cytomegalovirus (CMV) Anti-HAV Anti-HBc Anti-HBe Anti-HBs Anti-HCV Anti-HDV Anti-HIV-1 Anti-HIV-2 Anti-HTLV-I Anti-HTLV-I/II Anti-HTLV-II Anti-Mitochondrial Anti-nDNA Anti-RNP Anti-Scl-70 Anti-Sm Anti-Smooth Muscle Anti-SS-A Anti-SS-B Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) Antimony Antistreptolysin O (ASO) Antithrombin III (AT III) Apolipoprotein A-1 Apolipoprotein B Arsenic Ascorbic Acid AST/SGOT Autoimmune Negative Barbiturate Basophils (BASO) Benzodiazepines Benzoylecgonine Bile Acids Bilirubin Bilirubin (Direct) Bilirubin (Indirect) Bilirubin (Neonatal) Bilirubin (Total) Blood BNP Borrelia burgdorferi IgG 140 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

144 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Amylase (Pancreatic) ANA, Centromere Pattern ANA, Homogeneous Pattern ANA, Mitotic Spindle Pattern ANA, Nucleolar Pattern ANA, Speckled Pattern Androstenedione Androsterone Angiotensin I Anti-CCP Anti-CMV Anti-Cytomegalovirus (CMV) Anti-HAV Anti-HBc Anti-HBe Anti-HBs Anti-HCV Anti-HDV Anti-HIV-1 Anti-HIV-2 Anti-HTLV-I Anti-HTLV-I/II Anti-HTLV-II Anti-Mitochondrial Anti-nDNA Anti-RNP Anti-Scl-70 Anti-Sm Anti-Smooth Muscle Anti-SS-A Anti-SS-B Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) Antimony Antistreptolysin O (ASO) Antithrombin III (AT III) Apolipoprotein A-1 Apolipoprotein B Arsenic Ascorbic Acid AST/SGOT Autoimmune Negative Barbiturate Basophils (BASO) Benzodiazepines Benzoylecgonine Bile Acids Bilirubin Bilirubin (Direct) Bilirubin (Indirect) Bilirubin (Neonatal) Bilirubin (Total) Blood BNP Borrelia burgdorferi IgG Visit myeinserts.com to view product inserts online, anytime

145 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability 142 See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Buprenorphine Butalbital C-Peptide C-Reactive Protein C-Telopeptide (CTx) C1 Inhibitor CA 15-3 CA 19-9 CA CA 50* CA 72-4* CA 125 Cadmium Caffeine Calcitonin Calcium Calcium (Ionized) Calcium (Total) Cannabinoid Metabolite Cannabinoids Carbamazepine Carbamazepine (Free) Carboxyhemoglobin CASA* Casts CBC CEA Cellular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Concentration Mean of Gated Red Blood Cells (CHCMg) Cellular Hemoglobin Concentration Mean of Reticulocytes (CHCMr) Centromere Pattern Ceruloplasmin CH50 Chlamydia trachomatis Chlamydia trachomatis IgG Chloramphenicol Chlordiazepoxide Chloride Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Cholinesterase Chromium Cimetidine CK (Total) CK Electrophoresis CK-BB Isoenzyme CK-MB Isoenzyme CK-MM Isoenzyme Clarity Clomipramine Clonazepam CO2 Cobalt Cocaine *International use only Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

146 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Buprenorphine Butalbital C-Peptide C-Reactive Protein C-Telopeptide (CTx) C1 Inhibitor CA 15-3 CA 19-9 CA CA 50* CA 72-4* CA 125 Cadmium Caffeine Calcitonin Calcium Calcium (Ionized) Calcium (Total) Cannabinoid Metabolite Cannabinoids Carbamazepine Carbamazepine (Free) Carboxyhemoglobin CASA* Casts CBC CEA Cellular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Concentration Mean of Gated Red Blood Cells (CHCMg) Cellular Hemoglobin Concentration Mean of Reticulocytes (CHCMr) Centromere Pattern Ceruloplasmin CH50 Chlamydia trachomatis Chlamydia trachomatis IgG Chloramphenicol Chlordiazepoxide Chloride Cholesterol (HDL) Cholesterol (LDL) Cholesterol (Total) Cholinesterase Chromium Cimetidine CK (Total) CK Electrophoresis CK-BB Isoenzyme CK-MB Isoenzyme CK-MM Isoenzyme Clarity Clomipramine Clonazepam CO2 Cobalt Cocaine *International use only Visit myeinserts.com to view product inserts online, anytime

147 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability 144 See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Cocaine Metabolite Codeine Color Complement C1q Complement C3 Complement C4 Copper Coproporphyrin Cortisol Creatine Creatine Kinase (CK) Creatinine CRP Crystals Cyclosporine Cyfra 21-1* Cystatin C Cystine Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM d-amphetamine D-dimer d-methamphetamine Dehydroepiandrosterone Deoxyhemoglobin Deoxypyridinoline (DPD) Desalkylflurazepam Desipramine Desmethyldoxepin DHEA DHEA Sulfate Diazepam Digitoxin Digoxin Disopyramide Dopamine Doxepin EBNA IgG EBV EA IgG Ecstasy (MDMA) EDDP (Methadone Metabolite) Eosinophils (EOS) Epinephrine Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM Erythrocyte Sedimentation Rate (ESR) Erythropoietin (EPO) Estradiol Estriol (Free) Estriol (Total) Estrogen (Total) Ethanol Ethosuximide Ethylene Glycol Etiocholanolone *International use only Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

148 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Cocaine Metabolite Codeine Color Complement C1q Complement C3 Complement C4 Copper Coproporphyrin Cortisol Creatine Creatine Kinase (CK) Creatinine CRP Crystals Cyclosporine Cyfra 21-1* Cystatin C Cystine Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM d-amphetamine D-dimer d-methamphetamine Dehydroepiandrosterone Deoxyhemoglobin Deoxypyridinoline (DPD) Desalkylflurazepam Desipramine Desmethyldoxepin DHEA DHEA Sulfate Diazepam Digitoxin Digoxin Disopyramide Dopamine Doxepin EBNA IgG EBV EA IgG Ecstasy (MDMA) EDDP (Methadone Metabolite) Eosinophils (EOS) Epinephrine Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM Erythrocyte Sedimentation Rate (ESR) Erythropoietin (EPO) Estradiol Estriol (Free) Estriol (Total) Estrogen (Total) Ethanol Ethosuximide Ethylene Glycol Etiocholanolone *International use only Visit myeinserts.com to view product inserts online, anytime

149 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Everolimus Factors II, V, VII, VIII, IX, X, XI and XII Fentanyl Ferritin Fibrinogen FK-506 Flecainide Fluoride Folate Folate (RBC) Folic Acid (Folate) Fructosamine FSH Gastrin Gentamicin GGT GLDH Globulin Glucagon Glucose Glutethimide Granulocytes (GRAN) Haloperidol Haptoglobin HAV-IgM HBc-IgM HBDH HBeAg HBsAg HBV hcg hcg (Total) hcg-β Subunit HCV HDL Cholesterol Helicobacter pylori IgG Hematocrit (HCT) Hemoglobin (HGB) Hemoglobin (Total) Hemoglobin (Total Glycated) Hemoglobin A1 Hemoglobin A1C Hemoglobin A2 Hemoglobin Concentration Distribution Width (HDW) Hemoglobin F Hemoglobin S Hemopexin Heroin Metabolite Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgG Herpes Simplex Virus Type 2 (HSV-2) IgM hgh Hippuric Acid HIV Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

150 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Everolimus Factors II, V, VII, VIII, IX, X, XI and XII Fentanyl Ferritin Fibrinogen FK-506 Flecainide Fluoride Folate Folate (RBC) Folic Acid (Folate) Fructosamine FSH Gastrin Gentamicin GGT GLDH Globulin Glucagon Glucose Glutethimide Granulocytes (GRAN) Haloperidol Haptoglobin HAV-IgM HBc-IgM HBDH HBeAg HBsAg HBV hcg hcg (Total) hcg-β Subunit HCV HDL Cholesterol Helicobacter pylori IgG Hematocrit (HCT) Hemoglobin (HGB) Hemoglobin (Total) Hemoglobin (Total Glycated) Hemoglobin A1 Hemoglobin A1C Hemoglobin A2 Hemoglobin Concentration Distribution Width (HDW) Hemoglobin F Hemoglobin S Hemopexin Heroin Metabolite Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgG Herpes Simplex Virus Type 2 (HSV-2) IgM hgh Hippuric Acid HIV-1 Visit myeinserts.com to view product inserts online, anytime

151 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) HIV-1 Ag Homocysteine Homogenous Pattern hs-crp Human Papillomavirus (HPV) HVA Hydromorphone Hydroxyproline (Free) Hydroxyproline (Total) Ibuprofen Imipramine Immature Reticulocyte Fraction (IRF) Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin G Subclasses 1 4 Immunoglobulin M (IgM) Immunoreactive Trypsinogen (IRT) Insulin Insulin Growth Factor I (IGF-I) Intact PTH Iron Iron (TIBC) Iron (UIBC) IRT Isopropanol (Isopropyl Alcohol) Kappa Light Chain Ketones Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) Lambda Light Chain LAP Arylamidase Large Unstained Cells (LUC) LD Electrophoresis LD-1 LD-1 Isoenzyme LD-2 LD-3 LD-4 LD-5 LDH (Total) LDL Cholesterol Lead Leukocytes Lidocaine Lipase Lipoprotein (a) Lithium Lormetazepam Luteinizing Hormone (LH) LYMPH (W-SCC & W-SCR) Lymphocytes (LYMPH) Lysergic Acid Diethylamide (LSD) Magnesium Mandelic Acid 148 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

152 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability HIV-1 Ag Homocysteine Homogenous Pattern hs-crp Human Papillomavirus (HPV) HVA Hydromorphone Hydroxyproline (Free) Hydroxyproline (Total) Ibuprofen Imipramine Immature Reticulocyte Fraction (IRF) Immunoglobulin A (IgA) Immunoglobulin E (IgE) Immunoglobulin G (IgG) Immunoglobulin G Subclasses 1 4 Immunoglobulin M (IgM) Immunoreactive Trypsinogen (IRT) Insulin Insulin Growth Factor I (IGF-I) Intact PTH Iron Iron (TIBC) Iron (UIBC) IRT Isopropanol (Isopropyl Alcohol) Kappa Light Chain Ketones Lactate (Lactic Acid) Lactate Dehydrogenase (LDH) Lambda Light Chain LAP Arylamidase Large Unstained Cells (LUC) LD Electrophoresis LD-1 LD-1 Isoenzyme LD-2 LD-3 LD-4 LD-5 LDH (Total) LDL Cholesterol Lead Leukocytes Lidocaine Lipase Lipoprotein (a) Lithium Lormetazepam Luteinizing Hormone (LH) LYMPH (W-SCC & W-SCR) Lymphocytes (LYMPH) Lysergic Acid Diethylamide (LSD) Magnesium Mandelic Acid Visit myeinserts.com to view product inserts online, anytime

153 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability 150 See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Manganese Marijuana Metabolite MDA MDEA MDMA Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Corpuscular Volume of Gated Red Blood Cells (MVCg) Mean Corpuscular Volume of Reticulocytes (MCVr) Mean Hemoglobin Content of All Gated Red Cells (CHg) Mean Hemoglobin Content of Reticulocytes (CHr) Mean Platelet Volume (MPV) Meperidine Mercury Metanephrine Metanephrine (Total) Methadone Methadone Metabolite (EDDP) Methamphetamine Methanol (Methyl Alcohol) Methaqualone Methemoglobin Methotrexate Methyprylon Microalbumin Microscopics (RBC, WBC, Crystals, Casts) MID Mitochondrial Mitotic Spindle Pattern Mixed Cell Percent (MXD) Monocytes (MONO) Morphine Morphine (Free) Morphine-3-β-d-Glucuronide Mumps Virus IgG MXD (W-MCC & W-MCR) Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM Myoglobin N-Acetylprocainamide (NAPA) N-Telopeptide (NTx) ndna Neisseria gonorrhoeae Netilmicin Neuron Specific Enolase (NSE)* NEUT (W-LCC & W-LCR) NEUT X NEUT Y Neutrophils (NEUT) Nickel Nicotine Nitrite Non-treponemal Antibodies (Syphilitic Reagin) Norclomipramine *International use only Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

154 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Manganese Marijuana Metabolite MDA MDEA MDMA Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Corpuscular Volume of Gated Red Blood Cells (MVCg) Mean Corpuscular Volume of Reticulocytes (MCVr) Mean Hemoglobin Content of All Gated Red Cells (CHg) Mean Hemoglobin Content of Reticulocytes (CHr) Mean Platelet Volume (MPV) Meperidine Mercury Metanephrine Metanephrine (Total) Methadone Methadone Metabolite (EDDP) Methamphetamine Methanol (Methyl Alcohol) Methaqualone Methemoglobin Methotrexate Methyprylon Microalbumin Microscopics (RBC, WBC, Crystals, Casts) MID Mitochondrial Mitotic Spindle Pattern Mixed Cell Percent (MXD) Monocytes (MONO) Morphine Morphine (Free) Morphine-3-β-d-Glucuronide Mumps Virus IgG MXD Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM Myoglobin N-Acetylprocainamide (NAPA) N-Telopeptide (NTx) ndna Neisseria gonorrhoeae Netilmicin Neuron Specific Enolase (NSE)* NEUT (W-LCC & W-LCR) NEUT X NEUT Y Neutrophils (NEUT) Nickel Nicotine Nitrite Non-treponemal Antibodies (Syphilitic Reagin) Norclomipramine *International use only Visit myeinserts.com to view product inserts online, anytime

155 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Nordiazepam Nordoxepin Norepinephrine Normetanephrine Norpropoxyphene Nortriptyline NT-proBNP Nucleated Red Blood Cells (NRBC) Nucleated Red Blood Cells/100 WBC (NRBC/WBC%) Nucleolar Pattern Oligoclonal Banding (IgG) Opiates Osmolality Osteocalcin Oxazepam Oxycodone Oxygen Content Oxyhemoglobin PAP pco2 PCT PDW Pentachlorophenol Pentobarbital ph Phencyclidine (PCP) Phenobarbital Phenol Phenothiazines Phenylalanine Phenylglyoxylic Acid Phenytoin Phenytoin (Free) Phospholipids Phosphorus Plasminogen Platelecrit (PCT) Platelet Distribution Width (PDW) Platelet Volume Distribution Width (PDW) Platelets (PLT) Platelets Impedance Method (PLTi) Platelets, Optical Count (PLTo) po2 Porphyrins (Total) Potassium Prealbumin Pregnancy (hcg) Pregnancy (Qualitative) Pregnanetriol Primidone Procainamide Progesterone Prolactin Properdin Factor B Propoxyphene 152 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

156 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Nordiazepam Nordoxepin Norepinephrine Normetanephrine Norpropoxyphene Nortriptyline NT-proBNP Nucleated Red Blood Cells (NRBC) Nucleated Red Blood Cells/100 WBC (NRBC/WBC%) Nucleolar Pattern Oligoclonal Banding (IgG) Opiates Osmolality Osteocalcin Oxazepam Oxycodone Oxygen Content Oxyhemoglobin PAP pco2 PCT PDW Pentachlorophenol Pentobarbital ph Phencyclidine (PCP) Phenobarbital Phenol Phenothiazines Phenylalanine Phenylglyoxylic Acid Phenytoin Phenytoin (Free) Phospholipids Phosphorus Plasminogen Platelecrit (PCT) Platelet Distribution Width (PDW) Platelet Volume Distribution Width (PDW) Platelets (PLT) Platelets Impedance Method (PLTi) Platelets, Optical Count (PLTo) po2 Porphyrins (Total) Potassium Prealbumin Pregnancy (hcg) Pregnancy (Qualitative) Pregnanetriol Primidone Procainamide Progesterone Prolactin Properdin Factor B Propoxyphene Visit myeinserts.com to view product inserts online, anytime

157 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) Propranolol Protein (Total) Protein C Protein Electrophoresis Protein S Protein-to-Creatinine Ratio Prothrombin Time (PT) PSA PSA (Free) Pseudocholinesterase PTH-MM PTH Pyridinium Crosslinks (DPD + PYD) Pyridinoline (PYD) Pyrilamine Quinidine Quinine RDW-SD Reagin Red Blood Cells (RBC) Red Blood Cells, Optical (RBCo) Red Cell Distribution Width (RDW) Red Cell Distribution Width-CV (RDW-CV) Red Cell Distribution Width-SD (RDW-SD) Red Cell Folate Renin Reticulocyte (Retic) Reticulocyte Count Retinol Binding Protein (RBP) Rheumatoid Factor RNP Rubella Virus IgG Rubella Virus IgM Rubeola Virus (Measles) IgG S-100* Salicylate Scl-70 Secobarbital Sedimentation Rate (ESR) Selenium Serotonin SHBG (Sex Hormone Binding Globulin) Sirolimus Sm Smooth Muscle Sodium Soluble Transferrin Receptor (stfr) Somatomedin-C Specific Gravity Speckled Pattern Spun Hematocrit (Spun HCT) SS-A SS-B Syphilis RPR T3 (Free) *International use only 154 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

158 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability Propranolol Protein (Total) Protein C Protein Electrophoresis Protein S Protein-to-Creatinine Ratio Prothrombin Time (PT) PSA PSA (Free) Pseudocholinesterase PTH-MM PTH Pyridinium Crosslinks (DPD + PYD) Pyridinoline (PYD) Pyrilamine Quinidine Quinine RDW-SD Reagin Red Blood Cells (RBC) Red Blood Cells, Optical (RBCo) Red Cell Distribution Width (RDW) Red Cell Distribution Width-CV (RDW-CV) Red Cell Distribution Width-SD (RDW-SD) Red Cell Folate Renin Reticulocyte (Retic) Reticulocyte Count Retinol Binding Protein (RBP) Rheumatoid Factor RNP Rubella Virus IgG Rubella Virus IgM Rubeola Virus (Measles) IgG S-100* Salicylate Scl-70 Secobarbital Sedimentation Rate (ESR) Selenium Serotonin SHBG (Sex Hormone Binding Globulin) Sirolimus Sm Smooth Muscle Sodium Soluble Transferrin Receptor (stfr) Somatomedin-C Specific Gravity Speckled Pattern Spun Hematocrit (Spun HCT) SS-A SS-B Syphilis RPR T3 (Free) *International use only Visit myeinserts.com to view product inserts online, anytime

159 Control Analyte Index See page number Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability See Blood Gas Chart See Hematology Chart See Infectious Disease Chart See Urine Toxicology Charts Anemia Assayed Chemistry Assayed Multiqual Assayed Multiqual Premium Autoimmune Benzo/TCA (Sets A & B) Cardiac Markers LT Cardiac Markers LT, Level Low Cardiac Markers Plus Cardiac Markers Plus LT CK/LD Isoenzyme Coagulation D-dimer Diabetes (Liquid) Diabetes (Lyophilized) Drug Free Serum Elevated CRP Endocrine Ethanol/Ammonia Fertility Hemoglobin A1C Linearity Set Hemoglobin A2 Hemostasis Homocysteine Hypertension Markers Immunoassay Plus (Liquid) Immunoassay Plus (Lyophilized) Immunology (Liquid) T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) Tacrolimus (FK 506) TBG Testosterone Testosterone (Free) Thallium THC Metabolite Theophylline Thrombin Time (TT) Thyroglobulin (Tg) Tobramycin Total CK Total Red Blood Cell Counts in Retic Channel (Retic RBC) Toxoplasma gondii IgG Toxoplasma gondii IgM Tramadol* Transferrin Trazodone Treponema pallidum (Syphilis) IgG Treponema pallidum (Syphilis) IgM Trichloroacetic Acid Tricyclic Antidepressants Tricyclic Antidepressants (TCA) Screen Triglycerides Troponin I Troponin T Trypanosoma cruzi (T. cruzi) TSH Unconjugated Estriol (UE3) Urea Urea Nitrogen Uric Acid Urobilinogen Uroporphyrins Valproic Acid Valproic Acid (Free) Vancomycin Varicella Zoster Virus (VZV) IgG Vitamin B12 VMA West Nile Virus IgG West Nile Virus IgM White Blood Cells (WBC) White Blood Cells Counts Measured in Perox Channel (WBCP) Zinc *International use only 156 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

160 Control Analyte Index See page number Immunology Plus (Lyophilized) Lipids Maternal Serum Meter Trax Microalbumin Opiate Pediatric quantify quantify Plus Quantitative Urine Rheumatoid Factor Sedimentation Rate Serum Volatiles Specialty Immunoassay Spinal Fluid TDM (Liquid) TDM (Lyophilized) Tumor Marker (Liquid) Tumor Marker Plus (Lyophilized) Unasssayed Chemistry (Liquid) Unassayed Chemistry (Lyophilized) Unassayed Multiqual Urinalysis Urine Bone Markers Urine Chemistry Urine Metals Whole Blood Whole Blood Immunosuppressant (Liquid) Whole Blood Immunosuppressant (Lyophilized) Whole Blood Metals Whole Blood Volatiles Analyte present Analyte present in endogenous levels Analyte present and no claims are made regarding performance or stability Analyte present in endogenous levels and no claims are made regarding performance or stability Tested and found to be negative Specimen validity criteria Values not for diagnostic use No claim is made for expected value or stability T3 (Total) T3 Uptake/T-Uptake T4 (Free) T4 (Total) Tacrolimus (FK 506) TBG Testosterone Testosterone (Free) Thallium THC Metabolite Theophylline Thrombin Time (TT) Thyroglobulin (Tg) Tobramycin Total CK Total Red Blood Cell Counts in Retic Channel (Retic RBC) Toxoplasma gondii IgG Toxoplasma gondii IgM Tramadol* Transferrin Trazodone Treponema pallidum (Syphilis) IgG Treponema pallidum (Syphilis) IgM Trichloroacetic Acid Tricyclic Antidepressants Tricyclic Antidepressants (TCA) Screen Triglycerides Troponin I Troponin T Trypanosoma cruzi (T. cruzi) TSH Unconjugated Estriol (UE3) Urea Urea Nitrogen Uric Acid Urobilinogen Uroporphyrins Valproic Acid Valproic Acid (Free) Vancomycin Varicella Zoster Virus (VZV) IgG *International use only Vitamin B12 VMA West Nile Virus IgG West Nile Virus IgM White Blood Cells (WBC) White Blood Cells Counts Measured in Perox Channel (WBCP) Zinc Visit myeinserts.com to view product inserts online, anytime

161 Molecular/Infectious Disease Controls Analyte Index Molecular Infectious Disease See page number Positive Controls Neg. Positive Controls Analyte present Negative for analyte AmpliPROBE CT/GC AmpliTrol CT/GC AmpliTrol HPV AmpliTrol III AmpliClear Assayed VIROTROL I-C Assayed VIROTROL I-E Assayed VIROTROL I-F Assayed VIROTROL II-A Assayed VIROTROL II-B Liquichek ToRCH Plus Liquichek ToRCH Plus IgM PneumoTrol PyloriTrol VIROTROL Chagas VIROTROL EBV VIROTROL HAV-IgM VIROTROL HBc-IgM VIROTROL HBeAg VIROTROL HIV-1 Ag Anti-Cytomegalovirus (CMV) Anti-HAV Anti-HBc Anti-HBe Anti-HBs Anti-HCV Anti-HDV Anti-HIV-1 Anti-HIV-2 Anti-HTLV-I Anti-HTLV-I/II Anti-HTLV-II Borrelia burgdorferi IgG Chlamydia trachomatis Chlamydia trachomatis IgG Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM EBNA IgG EBV EA IgG Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM HAV-IgM HBc-IgM HBeAg HBsAg HBV HCV Helicobacter pylori IgG Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgG Herpes Simplex Virus Type 2 (HSV-2) IgM HIV-1 HIV-1 Ag Human Papillomavirus (HPV) Mumps Virus IgG Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM Neisseria gonorrhoeae Non-treponemal Antibodies (Syphilitic Reagin) Rubella Virus IgG Rubella Virus IgM Rubeola Virus (Measles) IgG Syphilis RPR Toxoplasma gondii IgG Toxoplasma gondii IgM Treponema pallidum (Syphilis) IgG Treponema pallidum (Syphilis) IgM Trypanosoma cruzi (T. cruzi) Varicella Zoster Virus (VZV) IgG West Nile Virus IgG West Nile Virus IgM 158 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

162 Molecular/Infectious Disease Controls Analyte Index Infectious Disease See page number Positive Controls Negative Controls VIROTROL HIV-2 VIROTROL I VIROTROL II VIROTROL III VIROTROL IV VIROTROL Lyme VIROTROL MuMZ VIROTROL RPR Panel VIROTROL Syphilis LR-A & LR-B VIROTROL Syphilis Total VIROTROL ToRCH VIROTROL ToRCH-M VIROTROL WNV Liquichek ToRCH Plus Liquichek ToRCH Plus IgM VIROCLEAR VIROCLEAR EBV VIROCLEAR MuMZ VIROCLEAR ToRCH Analyte present Negative for analyte Anti-Cytomegalovirus (CMV) Anti-HAV Anti-HBc Anti-HBe Anti-HBs Anti-HCV Anti-HDV Anti-HIV-1 Anti-HIV-2 Anti-HTLV-I Anti-HTLV-I/II Anti-HTLV-II Borrelia burgdorferi IgG Chlamydia trachomatis Chlamydia trachomatis IgG Cytomegalovirus (CMV) IgG Cytomegalovirus (CMV) IgM EBNA IgG EBV EA IgG Epstein-Barr Virus (VCA) IgG Epstein-Barr Virus (VCA) IgM HAV-IgM HBc-IgM HBeAg HBsAg HBV HCV Helicobacter pylori IgG Herpes Simplex Virus Type 1 (HSV-1) IgG Herpes Simplex Virus Type 1 (HSV-1) IgM Herpes Simplex Virus Type 2 (HSV-2) IgG Herpes Simplex Virus Type 2 (HSV-2) IgM HIV-1 HIV-1 Ag Human Papillomavirus (HPV) Mumps Virus IgG Mycoplasma pneumoniae IgG Mycoplasma pneumoniae IgM Neisseria gonorrhoeae Non-treponemal Antibodies (Syphilitic Reagin) Rubella Virus IgG Rubella Virus IgM Rubeola Virus (Measles) IgG Syphilis RPR Toxoplasma gondii IgG Toxoplasma gondii IgM Treponema pallidum (Syphilis) IgG Treponema pallidum (Syphilis) IgM Trypanosoma cruzi (T. cruzi) Varicella Zoster Virus (VZV) IgG West Nile Virus IgG West Nile Virus IgM Visit myeinserts.com to view product inserts online, anytime

163 Hematology Controls Analyte Index See page number Analyte present Values not for diagnostic use No claim is made for expected value or stability Hematology (A) Hematology (C) Hematology (S) Hematology (X) Hematology 16 Hematology-16T Reticulocyte (A) Reticulocyte (A-I) Reticulocyte (C) Reticulocyte (S) Reticulocyte (X) Sedimentation Rate Basophils (BASO) Cellular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Concentration Mean of Gated Red Blood Cells (CHCMg) Cellular Hemoglobin Concentration Mean of Reticulocytes (CHCMr) Eosinophils (EOS) Erythrocyte Sedimentation Rate (ESR) Granulocytes (GRAN) Hematocrit (HCT) Hemoglobin (HGB) Hemoglobin Concentration Distribution Width (HDW) Immature Reticulocyte Fraction (IRF) Large Unstained Cells (LUC) LYMPH (W-SCC & W-SCR) Lymphocytes (LYMPH) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Mean Corpuscular Volume (MCV) Mean Corpuscular Volume of Gated Red Blood Cells (MCVg) Mean Corpuscular Volume of Reticulocytes (MCVr) Mean Hemoglobin Content of All Gated Red Cells (CHg) Mean Hemoglobin Content of Reticulocytes (CHr) Mean Platelet Volume (MPV) Mean Reticulocyte Volume (MRV) MID Monocytes (MONO) MXD (W-MCC & W-MCR) NEUT (W-LCC & W-LCR) Neutrophils (NEUT) NEUT X NEUT Y Nucleated Red Blood Cells (NRBC) Platelet Distribution Width (PDW) Plateletcrit (PCT) Platelets (PLT) Platelets, Optical Count (PLT-o) Red Blood Cell Distribution Width (RDW) Red Blood Cell Distribution Width-CV (RDW-CV) Red Blood Cell Distribution Width-SD (RDW-SD) Red Blood Cells (RBC) Reticulocyte (Retic) Total Red Blood Cell Counts in Retic Channel (Retic RBC) White Blood Cells (WBC) White Blood Cells Counts Measured in Perox Channel (WBCP Perox) 160 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

164 External Quality Assurance Services (EQAS ) Analyte Index See page number See page number Analyte present Blood Gas Cardiac Markers Clinical Chemistry (Monthly) Coagulation Ethanol/Ammonia Hematology Hemoglobin Immunoassay (Monthly) Lipids Serum Proteins Tumor Marker Therapeutic Drug Monitoring Urine Chemistry Analyte present Blood Gas Cardiac Markers Clinical Chemistry (Monthly) Coagulation Ethanol/Ammonia Hematology Hemoglobin Immunoassay (Monthly) Lipids Serum Proteins Tumor Marker Therapeutic Drug Monitoring Urine Chemistry 5-Hydroxyindoleacetic Acid (HIAA) Copper 17-α-OH-Progesterone Cortisol 25-OH Vitamin D Cortisol (Free) α-1 Acid Glycoprotein Creatine Kinase (CK) α-1 Antitrypsin Creatinine α-2 Macroglobulin Cyclosporine β-2 Microglobulin D-dimer Acetaminophen DHEA-Sulfate ACE Digoxin Acid Phosphatase (Total) Dopamine ACTH Epinephrine Alanine Aminotransferase (ALT/SGPT) Estradiol Albumin Estriol, Free (UE3) Aldosterone Ethanol Alkaline Phosphatase (ALP) Ethosuximide Alphafetoprotein (AFP) Ferritin Amikacin Fibrinogen Amitriptyline Folate Ammonia Follicle Stimulating Hormone (FSH) Amylase (Pancreatic) Gamma Glutamyltransferase (GGT) Amylase (Total) Gastrin Angiotensin Converting Enzyme (ACE) Gentamicin Antistreptolysin O (ASO) Glucose Apo-A1 Haptoglobin Apo-B hcg APTT HDL Cholesterol Aspartate Aminotransferase (AST/SGOT) Hematocrit (HCT) Antithrombin III (ATIII) Hemoglobin A1C Bilirubin (Direct) Hemoglobin A2 Bilirubin (Total) Hemoglobin BNP Hemoglobin (Total Glycated) C-Peptide hgh C-Reactive Protein (CRP) Homovanillic Acid (HVA) CA 15-3 hs-crp CA 19-9 Hydroxyproline (Total) CA IgA CA 125 IgE Caffeine IgG Calcitonin IgM Calcium (Ionized) INR Calcium (Total) Carbamazepine Insulin Intact PTH Carbon Dioxide (CO2) Iron Carcinoembryonic Antigen (CEA) Iron Binding Capacity, Total (TIBC) Ceruloplasmin Iron Binding Capacity, Unsaturated (UIBC) Chloride Kappa Light Chain (Total) Cholesterol (HDL) Lactate Cholesterol (LDL) Lactate Dehydrogenase (LDH) Cholesterol (Total) Lambda Light Chain (Total) CK-MB Mass LH Complement C3 Lipase Complement C4 Lithium Continued on page 162 Visit myeinserts.com to view product inserts online, anytime

165 External Quality Assurance Services (EQAS ) Analyte Index See page number See page number Analyte present Blood Gas Cardiac Markers Clinical Chemistry (Monthly) Coagulation Ethanol/Ammonia Hematology Hemoglobin Immunoassay (Monthly) Lipids Serum Proteins Tumor Marker Therapeutic Drug Monitoring Urine Chemistry Analyte present Blood Gas Cardiac Markers Clinical Chemistry (Monthly) Coagulation Ethanol/Ammonia Hematology Hemoglobin Immunoassay (Monthly) Lipids Serum Proteins Tumor Marker Therapeutic Drug Monitoring Urine Chemistry Magnesium Thyroxine (FT4), Free Mean Corpuscular Hemoglobin (MCH) Thyroxine (T4), Total Mean Corpuscular Hemoglobin Concentration (MCHC) Tobramycin Mean Corpuscular Volume (MCV) Transferrin Mean Platelet Volume (MPV) Tricyclic Antidepressants (TCA) Screen Metanephrine Triglycerides Methotrexate Triiodothyronine (FT3), Total Microalbumin Triiodothyronine (T3), Total Myoglobin Troponin I Norepinephrine Troponin T Normetanephrine Urea Nortriptyline Urea Nitrogen NSE Uric Acid NT-proBNP Valproic Acid Osmolality Vancomycin pco2 Vanillylmandelic Acid (VMA) ph Vitamin B12 po2 White Blood Cells (WBC) Phenobarbital Phenytoin Zinc Phosphate Phosphorus Platelets (PLT) Potassium Prealbumin Primidone Progesterone Prolactin Protein C Activity Protein S Activity Protein (Total) PSA (Free) PSA (Free/Total Ratio) PSA (Total) PT Red Blood Cells (RBC) Red Blood Cell Distribution Width (RDW) Red Blood Cell Distribution Width (RDW-SD) Renin Rheumatoid Factor (RF) S100 Protein Salicylate Sex Hormone Binding Globulin (SHBG) Sodium T3 Uptake T-Uptake Testosterone Theophylline Thrombin Time (TT) Thyroid Stimulating Hormone (TSH) Thyroxine Binding Globulin (TBG) 162 Call to order in the United States. For the worldwide office nearest you, see the inside back cover.

166 Index Alphabetical Index Catalog Number Index Legal Notices