Reference Manual. Performance Verification Manual. For In Vitro Diagnostic Use. This manual is intended for UniCel DxC Systems AU Systems

Transcription

1 Reference Manual Performance Verification Manual For In Vitro Diagnostic Use This manual is intended for UniCel DxC Systems AU Systems PN A85514AC December 2016 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA U.S.A.

2 Performance Verification Manual PN A85514AC (December 2016) 2016 Beckman Coulter, Inc. All Rights Reserved Trademarks Beckman Coulter, the Beckman Coulter logo, Access, Synchron, DxC, UniCel, and AU are trademarks of Beckman Coulter, Inc. and are registered in the USPTO. All other trademarks are the property of their respective owners. Find us on the World Wide Web at: Beckman Coulter Eurocenter S.A. 22, rue Juste-Olivier Case Postale 1044 CH Nyon 1, Switzerland Tel: +41 (0) Beckman Coulter do Brazil Com e Imp de Prod de Lab Ltda Calçada Aldebarã, 39, Centro De Apoio 2 - Alphaville, Cep Santana De Parnaíba, Sp, Brasil Telefone: (11) CNPJ: / 製造販売業者 : ベックマン コールター株式会社 東京都江東区有明三丁目 5 番 7 号 TOC 有明ウエストタワー 贝克曼库尔特有限公司, 美国加利福尼亚州,Brea 市,S. Kraemer 大街 250 号, 邮编 :92821 电话 :(001) Rx Only Original Instructions

3 Revision History A85514AC, 12/2016 CHANGES: CHAPTER 1, Performance Verification Updated the Beckman Coulter Clinical Systems section. Updated the Chemistries to be Brought Online During Beckman Coulter UniCel DxC Systems Installation section. Updated the Chemistries to be Brought Online During Beckman Coulter AU Systems Installation section. Updated the Performance Verification Studies section. Updated the Precision Evaluation section. Updated the Linearity/CAL Verification section. Updated the Method comparison or correlation section. CHAPTER 2, Precision Updated the Protocol section. Updated the Precision Guidelines Conventional Units (CU) section. Added the Urine Chemistries Precision Guidelines section. Added the CSF Chemistries Precision Guidelines section. Updated the Precision Guidelines International Units (SI) section. Added the Urine Chemistries Precision Guidelines section. Added the CSF Chemistries Precision Guidelines section. Updated the AU Systems Precision Guidelines section. CHAPTER 3, Linearity Updated the Linearity procedure. Updated the Recommended Linearity Materials section. Updated the Modular (MC) Chemistries Synchron Systems section. Updated the Cartridge (CC) Chemistries Synchron Systems section. Updated the Urine Analytical Ranges Synchron Systems section. Updated the CSF Analytical Ranges- Synchron Systems section. Updated the Serum/Plasma Analytical Ranges - AU Systems section. Updated the Urine Chemistry Analytical Ranges- AU Systems section. Updated the CSF Chemistry Analytical Ranges- AU Systems section. CHAPTER 4, Method Comparison Updated the Method Comparison/Correlation Protocol Guidelines section. PN A85514AC iii

4 Revision History CHAPTER 5, Beckman Coulter Clinical System DATs Updated the DAT Testing AU Systems section. A22219AA, 12/2004 A22219AB, 10/2005 A22219AC, 06/2007 A22219AD, 02/2008 A22219AE, 12/2008 A22219AF, 09/2009 A85514AA, 09/2009 A85514AB, 03/2014 iv PN A85514AC

5 Contents Revision History,iii CHAPTER 1: Performance Verification,1-1 Beckman Coulter Clinical Systems, 1-1 Chemistries to be Brought Online During Beckman Coulter UniCel DxC Systems Installation,1-2 Chemistries to be Brought Online During Beckman Coulter AU/DxC 700 AU Systems Installation,1-3 Performance Verification Studies, 1-4 Purpose,1-4 Overview,1-4 Precision Evaluation, 1-5 Linearity/CAL Verification, 1-5 Method comparison or correlation:, 1-5 CHAPTER 2: Precision, 2-1 Precision Studies Protocol, 2-1 Precision Studies, 2-1 Protocol, 2-1 Synchron Systems Precision Guidelines, 2-2 Precision Guidelines Conventional Units (CU), 2-2 Urine Chemistries Precision Guidelines, 2-5 CSF Chemistries Precision Guidelines, 2-6 Synchron Systems Precision Guidelines, 2-7 Precision Guidelines International Units (SI), 2-7 Urine Chemistries Precision Guidelines, 2-10 CSF Chemistries Precision Guidelines, 2-11 AU/DxC 700 AU Systems Precision Guidelines, 2-12 Within-Run Precision Data Sheet, 2-18 CHAPTER 3: Linearity,3-1 Linearity Protocol, 3-1 Purpose,3-1 Linearity:, 3-1 Recommended Linearity Materials, 3-2 Serum/Plasma Analytical Ranges - Synchron Systems, 3-3 v

6 Contents Modular (MC) Chemistries Synchron Systems, 3-3 Cartridge (CC) Chemistries Synchron Systems, 3-3 Urine Analytical Ranges Synchron Systems, 3-7 CSF Analytical Ranges- Synchron Systems, 3-9 Serum/Plasma Analytical Ranges - AU/DxC 700 AU Systems, 3-10 Urine Chemistry Analytical Ranges- AU/DxC 700 AU Systems, 3-14 CSF Chemistry Analytical Ranges- AU/DxC 700 AU Systems, 3-15 Linearity Study, 3-16 CHAPTER 4: Method Comparison, 4-1 Method Comparison/Correlation Protocol, 4-1 Protocol, 4-1 Terminology for Correlation/Method Comparison Studies, 4-2 Terminology, 4-2 Patient Correlation Data Worksheet, 4-3 CHAPTER 5: Beckman Coulter Clinical System DATs, 5-1 Drugs of Abuse Chemistries, 5-1 DAT Testing Synchron Systems, 5-1 Qualitative Cutoff Levels, 5-1 DAT Testing AU/DxC 700 AU Systems, 5-2 Qualitative Cutoff Levels, 5-2 Concordance/Method Comparison Protocol, 5-3 Drugs of Abuse Concordance Data Summary,5-4 DAT Concordance Studies, 5-6 DAT Concordance Studies, 5-7 vi

7 CHAPTER 1 Performance Verification Beckman Coulter Clinical Systems We are pleased to present the Beckman Coulter Clinical Systems Performance Verification manual, designed to assist you in making a smooth transition integrating your new Clinical System into your daily laboratory routine. Please take time to review this packet thoroughly with your Beckman Coulter Clinical Systems Engineer and Beckman Coulter Clinical Applications Specialist while they are installing your new system. In addition to providing guidelines for evaluating precision and linearity, we have included some guidelines for performing method comparison studies. Performing a method comparison helps to evaluate any differences in recovery between different methods and/or different instrumentation, allowing adjustments of the reference interval, if necessary, when changing methods. The Beckman Coulter Clinical Systems Performance Verification Manual provides you with a basic guideline for verifying the performance of your new Beckman Coulter System. However, your current laboratory policies and/or your local regulatory agency may dictate more specific guidelines for your laboratory to follow. Beckman Coulter provides complimentary services including data reduction for Precision, Linearity, and Method Comparison studies. Beckman Coulter may be able to provide assistance in data reduction for additional studies. Contact your Beckman Coulter Representative for details. We hope you will find the information contained in the Performance Verification Manual a useful tool for making a smooth transition to your new Beckman Coulter Clinical System. PN A85514AC 1-1

8 Performance Verification Chemistries to be Brought Online During Beckman Coulter UniCel DxC Systems Installation Chemistries to be Brought Online During Beckman Coulter UniCel DxC Systems Installation Completed 3 Critical Care P a L b C c General Chems P L C TDMs P L C Proteins Serology Albumin ALP Acetaminophen ASO Blood Urea ALT Carbamazepine ApoA Nitrogen Calcium Amylase/p-Amylase Digoxin ApoB Carbon AST Gentamicin C-Reactive Dioxide Protein Chloride Cholesterol Phenobarbital CRPH Creatinine CK Phenytoin Complement C3 Glucose CR-S Theophylline Complement C4 Phosphorus Direct Bilirubin Tobramycin Haptoglobin Potassium GGT Valproic Acid Ig-A Sodium HDLD Cholesterol Vancomycin Ig-G Total Protein Iron Ig-M Urea IBCT DATs Prealbumin LD Amphetamines Transferrin LD-P Barbiturates LDLD Cholesterol Benzodiazepines Lipase Cannabinoids 20ng UDRs Magnesium Cannabinoids 50ng AAG MicroAlbumin Cannabinoids 100ng AMIK Micro Total Protein Cocaine Metabolite Ceruloplasmin Total Bilirubin Methadone Cholinesterase Esoterics Triglyceride Methaqualone CKMB Alcohol Uric Acid Opiates 300ng Cyclosporine Ammonia Urea Opiates 2000ng Cystatin C CR-E Phencyclidine Homocysteine Lactate (LACT) Propoxyphene Quinidine Lithium Thyroids UIBC Hemoglobin Thyroxin (T4) DAT UDR s A1c T-Uptake Buprenorphine %HbA1c Ecstasy (MDMA) (calculation) Salicylate Oxycodone Serum BARB Serum BENZ Tricyclics Serum Tox a. P = Precision b. L = Linearity c. C = Correlation Not all chemistries are available in all geographies. P L C 1-2 PN A85514AC

9 Performance Verification Chemistries to be Brought Online During Beckman Coulter AU/DxC 700 AU Systems Installation 1 Chemistries to be Brought Online During Beckman Coulter AU/DxC 700 AU Systems Installation Completed 3 General Chems P a L b C c TDMs P L C Proteins Serology P L C ALT Acetaminophen AAG Albumin Amikacin AAT ALP Caffeine ASO Amylase Carbamazepine Apo A1 AST Digoxin Apo B Bicarbonate Disopyramide B-2 Microglobulin Calcium Ethosuximide Ceruloplasmin Chloride Gentamicin Complement 3 Cholesterol Lidocaine Complement 4 Creatinine Methotrexate C Reactive Protein CK NAPA Ferritin Direct Bilirubin Phenobarbital Haptoglobin GGT Phenytoin Ig A Glucose Primidone Ig G HDL Cholesterol Procainamide Ig M Iron Quinidine Prealbumin LDL Cholesterol Salicylic Acid Rheumatoid Factor LDH Theophylline Transferrin Lipase Tobramycin Magnesium Valproic Acid Inorganic Phosphorous Vancomycin Potassium Sodium DATs Thyroids Total Bilirubin Amphetamines Thyroxine (T4) Total Protein Barbiturate T-Uptake Triglyceride Benzodiazepine UIBC Cannabinoid Esoteric Urea Nitrogen Cocaine Metabolite Ammonia Uric Acid Creatinine, Tox Cholinesterase Urinary/CSF Protein Ecstasy Creatine Kinase MB Urine/CSF Albumin Ethyl Alcohol D-Dimer LSD Hemoglobin Methadone A1c Methaqualone %HbA1c (calculation) Opiates Lactate Oxycodone Lithium Phencyclidine a. P = Precision b. L = Linearity c. C = Correlation Not all chemistries are available in all geographies. Propoxyphene Tricyclics, Tox UDRs Cystatin C Cyclosporine A Everolimus Homocysteine Mycophenolic Acid p-amylase Tacrolimus PN A85514AC 1-3

10 Performance Verification Performance Verification Studies Performance Verification Studies Purpose The purpose of this section is to provide information to enable you to verify the performance of your Beckman Coulter Clinical System. We have included subject descriptions and forms to assist you with evaluating precision, interpreting calibration verification/linearity, and recording method comparison. We have included information to assist you with: Precision Evaluation Calibration verification and/or Linearity to verify Analytical Measuring Range Method Comparison: Quantitative and Qualitative (if applicable) You will also find a summary form for your performance verification studies. IMPORTANT Local regulatory agencies may dictate frequency and/or method of analysis. Overview Much has been said and written about the impact that the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) will have on the laboratory and method evaluation. 1 It is often confusing to determine what is needed for accreditation and certification for the different types of testing categories. The following procedures will assist you in evaluating a new instrument or clinical test. Not all of these procedures are required by CLIA; however, some of them may be required by the College of American Pathologists (CAP), the Joint Commission of Accreditation of Healthcare Organizations (known as JCAHO), and/or individual state agencies. It is important to know state requirements as well as those of any other accrediting agencies that will impact your laboratory. The data generated from some of these procedures will help to establish the baseline performance of your Beckman Coulter Clinical System. With these considerations in mind, the laboratory must compile its own policies and procedures manual for method evaluation. The method evaluation procedures can be included in the procedures manual. The laboratory is empowered to make its own decisions as to what procedures are appropriate and which performance limits or specifications are acceptable. The data must be maintained for as long as the procedure is used, plus two years. The following is a synopsis of the performance characteristics to be verified at system installation. For more details, please refer to any text book on clinical chemistry or the various Clinical and Laboratory Standards Institute (CLSI) protocols available. 1 The Health Care Financing Administration (HCFA) s State Operations Manual (Appendix C: Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services), published March 1993, details how to comply with the CLIA regulations. 1-4 PN A85514AC

11 Performance Verification Overview 1 Precision Evaluation Within-Run: Used to compare to manufacturer s published specifications or Total Allowable Error (TEa) when precision specifications are listed as "typical performance." Helpful for future troubleshooting of individual chemistries Uses a patient pool or control material Precision can be monitored through use of Peer Group QC Programs such as Beckman Coulter QAP (UniCel DxC Systems only), Bio-Rad Unity Reports, and so forth. Linearity/CAL Verification CAP requires linearities be performed on all methods and semiannually thereafter. Linearity is demonstrated when the data points from specimens relative to each other fall on or near a straight line. Five levels, spanning the Analytical Measuring Range (AMR), are recommended. Typically 2-4 replicates are performed on each linearity sample/standard and plotted per the linearity material kit instructions. If the data points fall on a straight line, linearity is demonstrated. Method comparison or correlation: Comparison to a reference method Statistical equivalency of two methods or instrument systems Method Comparison like to like platforms A minimum of samples covering the Analytical Measuring Range. Refer to Westgard and D.G. Rhoads (EP Evaluator/Data Innovations). Method Comparison competitor platforms A minimum of 40 samples covering the Analytical Measuring Range. Refer to EP09-A3. PN A85514AC 1-5

12 Performance Verification Overview 1-6 PN A85514AC

13 CHAPTER 2 Precision Precision Studies Protocol Precision Studies Protocol Precision studies should be completed prior to the method comparison study, to verify optimal performance of the instrument. The minimum number of replicates is 20 for the low and high controls. 1. Instrument Statistics A within run precision is performed using the batch/sequential mode on the analyzer. 2. Prepare Sample A low and high control is used for precision studies with 20 replicates per control for within run precision studies. General Chemistries/TDM's Chemistry Controls and / or TDM controls. Esoteric Chemistries and UDR Chemistries Use specialty controls. Urine Chemistries Use Urine Controls. CSF Chemistries Use CSF Controls. DAT Chemistries DAT Quality Controls and / or DAT cutoff calibrator. 3. Precision Evaluation Verify SD/CV results with the guidelines provided in this manual or with information found in the appropriate Synchron/AU Chemistry Instructions for Use. For Chemistries that have only typical precision guidelines listed in the Synchron/ AU Chemistry Instructions for Use, use Total Allowable Error. PN A85514AC 2-1

14 Precision Synchron Systems Precision Guidelines Synchron Systems Precision Guidelines Precision Guidelines Conventional Units (CU) Table 2.1 Precision Guidelines - Serum/Plasma Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV MC Side Tests ALBm g/dl BUNm mg/dl CALC mg/dl CL mmol/l CO2 mmol/l CREm mg/dl GLUCm mg/dl K mmol/l NA mmol/l PHOSm mg/dl TPm g/dl UREAm mg/dl CC Side Tests ACTM μg/ml ALB g/dl ALP IU/L ALT IU/L AMM μg/dl AMY7 U/L Apo A mg/dl Apo B mg/dl ASO- IU/mL AST IU/L BUN mg/dl C3 mg/dl C4 mg/dl CAR μg/ml PN A85514AC

15 Precision Synchron Systems Precision Guidelines 2 Table 2.1 Precision Guidelines - Serum/Plasma (Continued) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV CHOL mg/dl CK IU/L CR-S mg/dl CR-E mg/dl CRP mg/dl CRPH mg/dl DATs ma/min DBIL mg/dl DIGN ng/ml ETOH mg/dl FE μg/dl GEN μg/ml GGT IU/L GLUH mg/dl b N/A 4.0 c HbA1c-/HbA1c3 % 7.5b N/A 4.0c HDL mg/dl HPT mg/dl IBCT μg/dl Ig-A mg/dl Ig-G mg/dl Ig-M mg/dl LACT mg/dl LD IU/L LDLD mg/dl LD-P IU/L or 5.0 d LI mmol/l or 7.5 d LIP U/L MA mg/dl MG mg/dl M-TP mg/dl PAB mg/dl PAM U/L PN A85514AC 2-3

16 Precision Synchron Systems Precision Guidelines Table 2.1 Precision Guidelines - Serum/Plasma (Continued) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV PHE μg/ml PHS mg/dl PHY μg/ml SALY mg/dl T4 μg/dl TBIL mg/dl TG/TG-B mg/dl THE μg/ml TOB μg/ml TP g/dl TRFN mg/dl TU % UREA mg/dl URIC mg/dl VANC μg/ml VPA μg/ml a. X-Over: When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/cv guideline) X 100. b. < 5% HbA1c- NGSP or < 0.4 g/dl A1c c. 5% HbA1c- NGSP or 0.4 g/dl A1c d. ORDAC % CV. Refer to UDR package inserts for Performance Characteristics information. 2-4 PN A85514AC

17 Precision Synchron Systems Precision Guidelines 2 Urine Chemistries Precision Guidelines Table 2.2 Precision Guidelines Urine Chemistries Conventional Units (CU) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV Modular (MC ) Chemistries BUNm mg/dl CALC mg/dl CL mmol/l CREm mg/dl GLUCm mg/dl K mmol/l NA mmol/l PHOSm mg/dl UREAm mmol/l Cartridge (CC) Chemistries AMY7 U/L BUN mg/dl CR-E mg/dl CR-S mg/dl ETOH mg/dl GLUH mg/dl MA mg/dl MG mg/dl M-TP mg/dl PAM U/L PHS mg/dl UREA mg/dl URIC mg/dl a. X-Over: When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/cv guideline) X 100. PN A85514AC 2-5

18 Precision Synchron Systems Precision Guidelines CSF Chemistries Precision Guidelines Table 2.3 Precision Guidelines CSF Chemistries Conventional Units (CU) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV CL mmol/l GLUCm mg/dl GLUH mg/dl LACT mg/dl M-TP mg/dl TPm mg/dl a. X-Over: When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/cv guideline) X PN A85514AC

19 Precision Synchron Systems Precision Guidelines 2 Synchron Systems Precision Guidelines Precision Guidelines International Units (SI) Table 2.4 Precision Guidelines - Serum/Plasma (SI Units) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV MC Side Tests ALBm g/l BUNm mmol/l CALC mmol/l CL mmol/l CO2 mmol/l CREm μmol/l GLUCm mmol/l K mmol/l NA mmol/l PHOSm mmol/l TPm g/l UREAm mmol/l CC Side Tests ACTM μmol/l ALB g/l ALP μkat/l ALT μkat/l AMM μmol/l AMY7 μkat/l Apo A g/l Apo B g/l ASO- IU/mL AST μkat/l BUN mmol/l C3 mg/l C4 mg/l CAR μmol/l CHOL mmol/l PN A85514AC 2-7

20 Precision Synchron Systems Precision Guidelines Table 2.4 Precision Guidelines - Serum/Plasma (SI Units) (Continued) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV CK μkat/l CR-S μmol/l CR-E μmol/l CRP mg/l CRPH mg/l DATs ma/min DBIL μmol/l DIGN nmol/l ETOH mmol/l FE μmol/l GEN μmol/l GGT μkat/l GLUH mmol/l b N/A 4.0 c HbA1c-/HbA1c3 % 7.5b N/A 4.0c HDL mmol/l HPT mg/l IBCT μmol/l Ig-A g/l Ig-G g/l Ig-M g/l LACT mmol/l LD μkat/l LDLD mmol/l LD-P μkat/l or 5.0 d LI mmol/l or 7.5 d LIP μkat/l MA mg/l MG mmol/l M-TP g/l PAB mg/l PAM μkat/l PHE μmol/l PHS mmol/l PHY μmol/l PN A85514AC

21 Precision Synchron Systems Precision Guidelines 2 Table 2.4 Precision Guidelines - Serum/Plasma (SI Units) (Continued) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV SALY mmol/l T4 nmol/l TBIL μmol/l TG/TG-B mmol/l THE μmol/l TOB μmol/l TP g/l TRFN g/l TU % UREA mmol/l URIC μmol/l VANC μmol/l VPA μmol/l a. Crossover (X-Over): When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/%cv guideline) x 100. b. < 5% HbA1c- NGSP or < 0.4 g/dl A1c c. 5% HbA1c- NGSP or 0.4 g/dl A1c d. ORDAC % CV. Refer to UDR package inserts for Performance Characteristics information. PN A85514AC 2-9

22 Precision Urine Chemistries Precision Guidelines Urine Chemistries Precision Guidelines Table 2.5 Precision Guidelines Urine Chemistries International Units (SI) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV Modular (MC ) Chemistries BUNm mmol/l CALC mmol/l CL mmol/l CREm μmol/l GLUCm mmol/l K mmol/l NA mmol/l PHOSm mmol/l UREAm mmol/l Cartridge (CC) Chemistries AMY7 μkat/l BUN mmol/l CR-E μmol/l CR-S μmol/l ETOH mmol/l GLUH mmol/l MA mg/l MG mmol/l M-TP g/l PAM μkat/l PHS mmol/l UREA mmol/l URIC μmol/l a. Crossover (X-Over): When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/%cv guideline) x PN A85514AC

23 Precision CSF Chemistries Precision Guidelines 2 CSF Chemistries Precision Guidelines Table 2.6 Precision Guidelines CSF Chemistries International Units (SI) Within-Run Test Units Total 1SD X-Over a %CV 1SD X-Over a %CV CL mmol/l GLUCm mmol/l GLUH mmol/l LACT mmol/l M-TP g/l TPm mg/l a. Crossover (X-Over): When the mean of the test precision data is less than or equal to the x-over value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the x-over value, compare the test %CV to %CV guideline given above to determine acceptability. X-Over value = (SD guideline/%cv guideline) x 100. PN A85514AC 2-11

24 Precision AU/DxC 700 AU Systems Precision Guidelines AU/DxC 700 AU Systems Precision Guidelines Table 2.7 Precision Guidelines AU/DxC 700 AU Chemistries - Serum/Plasma CONVENTIONAL Serum/Plasma Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) < 5% < 10% mg/dl α-1-acidglycoprotein AAG g/l < 10% < 5% < 5% < 10% mg/dl α-1-antitrypsin AAT g/l < 10% < 5% * * μg/ml Acetaminophen ACETA μmol/l * * < 3% < 3% g/dl Albumin ALB g/l < 3% < 3% < 5% < 10% IU/L Alkaline Phosphatase ALP μkat/l < 10% < 5% < 5% < 10% IU/L Alanine ALT μkat/l < 10% < 5% Aminotransferase * * μg/ml Amikacin AMIK μmol/l * * < 5% < 5% μg/dl Ammonia AMMON μmol/l < 5% < 5% < 5% < 10% U/L Amylase AMY μkat/l < 10% < 5% < 5% < 10% mg/dl Apolipoprotein A1 APO A1 g/l < 10% < 5% < 5% < 10% mg/dl Apolipoprotein B APO B g/l < 10% < 5% < 5% < 10% IU/mL Anti-Streptolysin O ASO IU/mL < 10% < 5% < 5% < 10% U/L Aspartate AST μkat/l < 10% < 5% Aminotransferase < 5% < 10% mg/dl β-2 Microglobulin B2M g/l < 10% < 5% < 3% or < 1.0 a < 7% or < 1.5 a meq/l Bicarbonate CO2 mmol/l < 7% or < 1.5 a < 3% or < 1.0 a < 5% or 0.15 a < 7.5% or 0.23 a mg/dl Bilirubin, D (OSR6x11) DBIL μmol/l < 7.5% or 3.9 a < 5% or 2.6 a < 7% or 0.07 a < 3% or 0.07 a < 8% or mg/dl Bilirubin, D 0.21 a (OSR6x181) DBIL μmol/l < 8% or 3.6 a < 5% or mg/dl Bilirubin, T TBIL μmol/l < 5% or 0.10 a 1.7 a < 7% or 1.2 a < 3% or 1.2 a < 3% < 5% mg/dl Complement 3 C3 g/l < 5% < 3% < 3% < 5% mg/dl Complement 4 C4 g/l < 5% < 3% * * μg/ml Caffeine CAFF μmol/l * * < 3% < 5% mg/dl Calcium Arsenazo CALA mmol/l < 5% < 3% 2-12 PN A85514AC

25 Precision AU/DxC 700 AU Systems Precision Guidelines 2 Table 2.7 Precision Guidelines AU/DxC 700 AU Chemistries - Serum/Plasma (Continued) CONVENTIONAL Serum/Plasma Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) < 3% or < 5% or mg/dl Calcium ocpc CA mmol/l < 5% or < 3% or < 0.25 a < 0.33 a < 0.08 a < 0.06 a * * μg/ml Carbamazepine CARB μmol/l * * < 5% < 10% mg/l Ceruloplasmin CER mg/dl < 10% < 5% < 3% < 5% meq/l Chloride CL mmol/l < 5% < 3% < 3% < 3% mg/dl Cholesterol CHOL mmol/l < 3% < 3% < 5% < 10% ku/l Cholinesterase CHE μkat/l < 10% < 5% < 5% < 10% U/L Creatine Kinase CK μkat/l < 10% < 5% < 5% or 2.3 a < 6.5% or U/L Creatine Kinase MB CKMB μkat/l < 6.5% or 3.0 a 0.05 a < 5% or 0.04 a < 3% < 6% mg/dl Creatinine CRE μmol/l < 6% < 3% < 5% or 1.0 a < 5% or mg/l C-Reactive Protein 1.0 a (OSR6x47) CRP mg/dl < 5% or 0.1 a < 5% or 0.1 a < 5% or 0.02 a < 10% or 0.02 a mg/l CRP High Sensitivity CRPHS mg/dl < 10% or a < 5% or a < 5% or 0.20 a < 10% or 0.25 a mg/l CRP Normal (OSR6x99) CRPN mg/dl < 10% or a < 5% or a * * ng/ml Digoxin DIG nmol/l * * < 10% < 10% μg FEU/mL D-Dimer DDIM μg FEU/mL < 10% < 10% * * μg/ml Disopyramide DISO μmol/l * * * * μg/ml Ethosuximide SUXI μmol/l * * < 8% < 11% ng/ml Ferritin FERR μg/l < 11% < 8% * * μg/ml Gentamicin GENT μmol/l * * < 5% < 10% U/L Gamma GGT μkat/l < 10% < 5% Glutamyltransferase < 3% < 3% mg/dl Glucose GLU mmol/l < 3% < 3% < 5% < 10% mg/dl Haptoglobin HAPT g/l < 10% < 5% 3% 4% % Hemoglobin A1c HBA1c % 4% 3% < 3% < 5% mg/dl HDL Cholesterol HDL-C mmol/l < 5% < 3% < 4.2% < 8% mg/dl Immunoglobulin A IGA g/l < 8% < 4.2% PN A85514AC 2-13

26 Precision AU/DxC 700 AU Systems Precision Guidelines Table 2.7 Precision Guidelines AU/DxC 700 AU Chemistries - Serum/Plasma (Continued) CONVENTIONAL Serum/Plasma Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) < 3.5% < 6% mg/dl Immunoglobulin G IGG g/l < 6% < 3.5% < 4.2% < 10% mg/dl Immunoglobulin M IGM g/l < 10% < 4.2% < 3% < 5% ug/dl Iron IRON μmol/l < 5% < 3% < 5% < 5% mg/dl Lactate LAC mmol/l < 5% < 5% < 5% < 10% U/L Lactate LDH μkat/l < 10% < 5% Dehydrogenase < 3% < 5% mg/dl LDL Cholesterol LDL-C mmol/l < 5% < 3% * * μg/ml Lidocaine LIDO μmol/l * * < 5% < 10% U/L Lipase LIP μkat/l < 10% < 5% < 3% < 5% mmol/l Lithium LI meq/l < 5% < 3% < 3% < 5% mg/dl Magnesium MG mmol/l < 5% < 3% * * μmol/l Methotrexate MTRX mol/l * * * * μg/ml N- NAPA μmol/l * * Acetylprocainamide * * μg/ml Phenobarbital PBARB μmol/l * * * * μg/ml Phenytoin PHENY μmol/l * * < 3% < 5% mg/dl Phosphorus PHOS mmol/l < 5% < 3% (Inorganic) < 3% < 5% meq/l Potassium K mmol/l < 5% < 3% < 5% < 10% mg/dl Prealbumin PALB g/l < 10% < 5% * * μg/ml Primidone PRIM μmol/l * * * * μg/ml Procainamide PROC μmol/l * * < 3% < 4% g/dl Protein, Total TP g/l < 4% < 3% * * μg/ml Quinidine QUIN μmol/l * * <10% for values 20 IU/ ml or <5% for values >20 IU/ ml < 10% IU/L Rheumatoid Factor RF IU/L < 10% <10% for values 20 IU/ ml or <5% for values >20 IU/ ml * * mg/dl Salicylic Acid SALI μmol/l * - < 3% < 5% meq/l Sodium NA mmol/l < 5% < 3% 2-14 PN A85514AC

27 Precision AU/DxC 700 AU Systems Precision Guidelines 2 Table 2.7 Precision Guidelines AU/DxC 700 AU Chemistries - Serum/Plasma (Continued) CONVENTIONAL Serum/Plasma Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) * * % T-Uptake TUP % * * * * μg/ml Theophylline THEO μmol/l * * * * μg/dl Thyroxine T4 nmol/l * * * * μg/ml Tobramycin TOB μmol/l * * < 3% < 5% mg/dl Transferrin TRF g/l < 5% < 3% < 3% < 5% mg/dl Triglyceride TRIG mmol/l < 5% < 3% < 2% < 3% mg/dl Uric Acid UA μmol/l < 3% < 2% < 3% < 5% mg/dl Urea Nitrogen BUN mmol/l < 5% < 3% < 8% < 10% μg/dl Unsaturated Iron UIBC μmol/l < 10% < 8% Binding Capacity * * μg/ml Valproic Acid VPA μmol/l * * * * μg/ml Vancomycin VANC μmol/l * * * Installation performance criteria is based on Total Allowable Error (TEa). Refer to UDR package inserts for Performance Characteristics information. PN A85514AC 2-15

28 Precision AU/DxC 700 AU Systems Precision Guidelines Table 2.8 AU/DxC 700 AU Precision Guidelines Urine Chemistries CONVENTIONAL Urine Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) ** ** U/L Amylase AMY μkat/l ** ** ** ** mg/dl Calcium Arsenazo CALA mmol/l ** ** < 3% or < 5% or mg/dl Calcium ocpc CA mmol/l < 5% or < 3% or < 0.25 a < 0.33 a < 0.08 a < 0.06 a ** ** meq/l Chloride CL mmol/l ** ** ** ** mg/dl Creatinine CRE μmol/l ** ** ** ** mg/dl Glucose GLU mmol/l ** ** ** ** mg/dl Magnesium MG mmol/l ** ** ** ** mg/dl Phosphorus PHOS mmol/l ** ** (Inorganic) ** ** meq/l Potassium K mmol/l ** ** < 4% < 5% mg/dl Urinary/ UP g/l < 5% < 4% CSF Protein ** ** meq/l Sodium NA mmol/l ** ** 5% or 1 a 10% or 2 a mg/l Urine/CSF Albumin UALB mg/dl 10% or 0.2 a 5% or 0.1 a ** ** mg/dl Urea Nitrogen BUN mmol/l ** ** < 3% < 5% mg/dl Uric Acid UA μmol/l < 5% < 3% a. Compare the % CV to the SD guideline and use the greater number. ** Installation performance criteria is based on Total Allowable Error (TEa). Refer to DAT package inserts for Performance Characteristics information. Refer to UDR package inserts for Performance Characteristics information PN A85514AC

29 Precision AU/DxC 700 AU Systems Precision Guidelines 2 Table 2.9 AU/DxC 700 AU Precision Guidelines CSF Chemistries CONVENTIONAL CSF Precision Specifications SI UNITS WITHIN (%CV) TOTAL (%CV) UNIT TEST UNITS TOTAL (%CV) WITHIN (%CV) *** *** mg/dl Glucose GLU mmol/l *** *** < 6 % or < 7.5 % or mg/dl Immunoglobulin G IgG g/l < 7.5 % or < 6 % or < 0.4 a < 0.5 a < a < a < 5% < 5% mg/dl Lactate LAC mmol/l < 5% < 5% < 4% < 5% mg/dl Urinary/ CSF Protein 5% or 1 10% or 2 mg/l Urine/CSF Albumin UP g/l < 5% < 4% UALB mg/dl 10% or 0.2 5% or 0.1 a. Compare the % CV to the SD guideline and use the greater number. *** Installation performance criteria is based on Total Allowable Error (TEa). Refer to UDR package inserts for Performance Characteristics information. PN A85514AC 2-17

30 Precision Within-Run Precision Data Sheet Within-Run Precision Data Sheet Beckman Clinical SYSTEM: SN: DATE: Sample: Chemistry Name Mean S.D. %C.V. Spec Limit a Comments a. Specified as the SD or %CV used per chemistry. Reviewed By: Date Reviewed: 2-18 PN A85514AC

31 CHAPTER 3 Linearity Linearity Protocol Purpose Linearity: Linearity is typically performed with five or more interrelated samples, with 2-4 replicates for each level. Data is plotted against the expected value or standard number. Commercially prepared standards or multiple dilutions of a high patient sample may be used. Procedure: 1 Verify adequate volume of reagents. 2 Verify calibrations have been completed and will not time out in the middle of procedure. 3 Verify controls have been completed and are within acceptable limits. 4 Program the instruments to run the selected analytes in 2-4 replicates. 5 For Linearity studies, plot the instrument values versus the linearity material kit instructions. PN A85514AC 3-1

32 Linearity Recommended Linearity Materials Recommended Linearity Materials Maine Standards ( ) 221 US Route 1 Cumberland Foreside, ME Fax: Sekisui Diagnostics, LLC ( ) 4 Hartwell Place Lexington, MA Verichem Laboratories ( ) 90 Narragansett Avenue Providence RI PN A85514AC

33 Linearity Serum/Plasma Analytical Ranges - Synchron Systems 3 Serum/Plasma Analytical Ranges - Synchron Systems Modular (MC) Chemistries Synchron Systems Table 3.1 Synchron MC Chemistries Serum/Plasma Analytical Ranges Modular (MC) Chemistry Serum/Plasma Conventional Units (CU) Analytical Ranges Serum/Plasma Chemistry ORDAC (CU) International Units (SI) Albumin (ALBm) 1-7 g/dl NA a g/l NA ORDAC (SI) Blood Urea Nitrogen (BUNm) mg/dl mg/dl mmol/l mmol/l Calcium 2-20 mg/dl NA mmol/l NA Carbon Dioxide 5-50 mmol/l NA 5-50 mmol/l NA Chloride mmol/l NA mmol/l NA Creatinine (CREm) mg/dl NA μmol/l NA Glucose (Oxidase) (GLUCm) mg/dl mg/dl mmol/l mmol/l Phosphorus (PHOSm) mg/dl NA mmol/l NA Potassium 1-15 mmol/l NA 1-15 mmol/l NA Sodium mmol/l NA mmol/l NA Total Prote in (TPm) 1-12 g/dl N A g/l N A Urea (UREAm) mg/dl mg/dl mmol/l mmol/l a. NA = Not Applicable Cartridge (CC) Chemistries Synchron Systems Table 3.2 Synchron CC Chemistries Serum/Plasma Analytical Ranges Cartridge Chemistry (CC) Serum/Plasma Conventional Units (CU) Analytical Ranges Serum/Plasma Chemistry ORDAC (CU) International Units (SI) Acetaminophen μg/ml NA a μmol/l NA ORDAC (SI) Alanine Aminotransferase (ALT) IU/L IU/L μkat/l μkat/l Albumin 1-7 g/dl NA g/l NA Alkaline Phosphatase (ALP) IU/L IU/L μkat/l μkat/l Ammonia μg/dl NA μmol/l NA Amylase G7 (AMY7) U/L U/L μkat/l μkat/l PN A85514AC 3-3

34 Linearity Serum/Plasma Analytical Ranges - Synchron Systems Table 3.2 Synchron CC Chemistries Serum/Plasma Analytical Ranges (Continued) Cartridge Chemistry (CC) Serum/Plasma Conventional Units (CU) Analytical Ranges Serum/Plasma Chemistry ORDAC (CU) International Units (SI) Antistreptolysin-O (ASO-) IU/mL IU/mL IU/mL IU/mL Apolipoprotein A (ApoA) mg/dl NA g/l NA Apolipoprotein B (ApoB) mg/dl NA g/l NA Aspartate Aminotransferase IU/L IU/L μkat/l μkat/l (AST) Blood Urea Nitrogen mg/dl NA mmol/l NA Carbamazepine 2-20 μg /ml NA μmol/l NA Cholesterol mg/dl mg/dl mmol/l mmol/l Compliment C mg/dl NA mg/l NA Compliment C mg/dl NA mg/l NA C-Reactive Protein mg/dl mg/dl mg/l mg/l High Sensitivity C-Reactive mg/dl mg/dl mg/l mg/l Protein Creatine Kinase IU/L IU/L μkat/l μkat/l Creatinine (CR-S) mg/dl NA μmol/l NA Creatinine Enzymatic (CR-E) mg/dl NA μmol/l NA Digoxin ng/ml NA a nmol/l NA Direct Bilirubin mg/dl NA μmol/l NA HDL (HDL) mg/dl NA mmol/l NA Direct LDL (LDLD) mg/dl NA mmol/l NA Ethanol (ETOH) mg/dl NA mmol/l NA Gamma Glutamyl Transferase IU/L IU/L μkat/l μkat/l (GGT) Gentamicin μg/ml NA μmol/l NA Glucose (Hexokinase, GLUH) mg/dl NA mmol/l NA ORDAC (SI) Haptoglobin mg/dl mg/dl mg/dl mg/l mg/l mg/l 3-4 PN A85514AC

35 Linearity Serum/Plasma Analytical Ranges - Synchron Systems 3 Table 3.2 Synchron CC Chemistries Serum/Plasma Analytical Ranges (Continued) Cartridge Chemistry (CC) Serum/Plasma HbA1c-/HbA1c3 Hb-/Hb3: 6-24 g/dl A1c-/A1c3: 0.3 g/dl-cal 5 %HbA1c: 4-17% NA Hb-/Hb3: mmol/l A1c-/A1c3: 0.19 Cal 5 mmol/l %HbA1c: 4-17% IBCT Total Iron Binding Capacity μg/dl NA μmol/l NA Immunoglobulin A mg/dl 6.50 mg/dl mg/dl g/l g/l g/l Immunoglobulin G mg/dl , g/l g/l mg/dl Immunoglobulin M mg/dl , g/l g/l mg/dl Iron (FE) μg/dl NA μmol/l NA Lactate (LACT) mg/dl NA mmol/l NA Lactate Dehydrogenase (LD) IU/L IU/L μkat/l μkat/l Lactate Dehydrogenase (LD-P) IU/L IU/L μkat/l μkat/l Lipase (LIP) U/L U/L μkat/l μkat/l Lithium mmol/l mmol/l mmol/l mmol/l Magnesium mg/dl NA mmol/l NA p-amylase (PAM) U/L U/L μkat/l 8-30 μkat/l Phenobarbital (PHE) 5-80 μg/ml NA μmol/l NA Phenytoin (PHY) μg/ml NA μmol/l NA Phosphorus (PHS) 1-12 mg/dl NA mmol/l NA Prealbumin 2-60 mg/dl NA mg/l NA Salicylate mg/dl NA mmol/l NA T-Uptake (TU) Calibrator Dependent NA Calibrator NA Dependent Theophylline 2-40 μg/ml NA μmol/l NA Thyroxine (T4) Conventional Units (CU) 2 μg/dl-high Cal Value Analytical Ranges Serum/Plasma Chemistry ORDAC (CU) NA International Units (SI) 25.8 mmo/l-high Cal Value ORDAC (SI) Tobramycin μg/ml NA μmol/l NA Total Bilirubin mg/dl NA μmol/l NA NA NA PN A85514AC 3-5

36 Linearity Serum/Plasma Analytical Ranges - Synchron Systems Table 3.2 Synchron CC Chemistries Serum/Plasma Analytical Ranges (Continued) Cartridge Chemistry (CC) Serum/Plasma Total Protein g/dl NA g/l NA Transferrin mg/dl NA g/l NA Triglyceride mg/dl NA mmol/l NA Urea mg/dl NA mmol/l NA Uric Acid mg/dl mg/dl μmol/l μmol/l Valproic Acid μg/ml NA μmol/l NA Vancomycin μg/ml μg/ml μmol/l μmol/l a. NA = Not Applicable Conventional Units (CU) Analytical Ranges Serum/Plasma Chemistry ORDAC (CU) International Units (SI) ORDAC (SI) 3-6 PN A85514AC

37 Linearity Urine Analytical Ranges Synchron Systems 3 Urine Analytical Ranges Synchron Systems Table 3.3 Synchron MC Chemistries Urine Analytical Ranges Modular (MC) Chemistry Urine Blood Urea Nitrogen (1:10 Dilution) (BUNm) Conventional Units (CU) Analytical Ranges Urine Chemistry ORDAC (CU) International Units (SI) ORDAC (SI) mg/dl mg/dl mmol/l mmol/l Calcium 2-30 mg/dl NA a mmol/l NA Chloride mmol/l NA mmol/l NA Creatinine (CREm) mg/dl NA mmol/l NA Glucose (Oxidase) (GLUCm) mg/dl mg/dl mmol/l mmol/l Phosphorus (1:10 Dilution) mg/dl NA mmol/l NA (PHOSm) Potassium mmol/l NA mmol/l NA Sodium mmol/l NA mmol/l NA Urea (1:10 Dilution) (UREAm) mg/dl mg/dl mmol/l mmol/l a. NA = Not Applicable PN A85514AC 3-7

38 Linearity Urine Analytical Ranges Synchron Systems Table 3.4 Synchron CC Chemistries Urine Analytical Ranges Cartridge (CC) Chemistry Urine Conventional Units (CU) Analytical Ranges Urine Chemistry ORDAC (CU) International Units (SI) Alcohol (ETOH) mg/dl NA mmol/l NA ORDAC (SI) Amylase G7 (AMY7) U/L U/L μkat/l μkat/l Blood Urea Nitrogen (BUN) mg/dl NA a mmol/l NA Creatinine (CR-S) mg/dl NA μmol/l NA Creatinine Enzymatic (CR-E) mg/dl NA μmol/l NA Glucose (Hexokinase, GLUH) mg/dl NA mmol/l NA Magnesium 1-70 mg/dl NA mmol/l NA MicroAlbumin mg/dl mg/dl mg/l mg/l Micro Total Protein (M-TP) mg/dl NA g/l NA p-amylase (PAM) U/L U/L μkat/l 8-30 μkat/l Phosphorus (PHS) mg/dl NA mmol/l NA Urea mg/dl NA mmol/l NA Uric Acid mg/dl NA μmol/l NA 3-8 PN A85514AC

39 Linearity CSF Analytical Ranges- Synchron Systems 3 CSF Analytical Ranges- Synchron Systems Table 3.5 Synchron CSF Analytical Ranges Analytical Ranges CSF Chemistry Modular Chemistry (MC) and Cartridge (CC) Chemistry CSF Conventional Units (CU) ORDAC (CU) International Units (SI) ORDAC (SI) Chloride MC mmol/l NA a mmol/l NA Glucose (Oxidase) (GLUCm) mg/dl mg/dl mmol/l mmol/l MC Total Protein (TPm) MC mg/dl NA mg/l NA Glucose (Hexokinase) mg/dl NA mmol/l NA (GLUH) CC Lactate (LACT) CC mg/dl NA mmol/l NA Micro Total Protein (M-TP) CC mg/dl NA g/l NA a. NA = Not Applicable Refer to UDR package inserts for Analytical Range information. PN A85514AC 3-9

40 Linearity Serum/Plasma Analytical Ranges - AU/DxC 700 AU Systems Serum/Plasma Analytical Ranges - AU/DxC 700 AU Systems Table 3.6 AU/DxC 700 AU Serum/Plasma Analytical Ranges Conventional AU Analytical Ranges Serum/Plasma Chemistry mg/dl α-1-acidglycoprotein AAG g/l mg/dl α-1-antitrypsin AAT g/l μg/ml Acetaminophen ACETA μmol/l g/dl Albumin ALB g/l IU/L Alkaline Phosphatase ALP μkat/l IU/L Alanine Aminotransferase ALT μkat/l μg/ml Amikacin AMIK μmol/l μg/dl Ammonia AMMON μmol/l U/L Amylase AMY μkat/L mg/dl Apolipoprotein A1 APO A g/l mg/dl Apolipoprotein B APO B g/l IU/mL Anti-Streptolysin O ASO IU/mL U/L Aspartate AST μkat/l Aminotransferase mg/dl β-2-microglobulin B2M g/l 2-45 meq/l Bicarbonate CO mmol/l 0-10 mg/dl Bilirubin, D (OSR6x11) DBIL μmol/l mg/dl Bilirubin, D (OSR6x181) DBIL μmol/l 0-30 mg/dl Bilirubin, T TBIL μmol/l mg/dl Complement 3 C g/l mg/dl Complement 4 C g/l 1-30 μg/ml Caffeine CAFF μmol/l 4-18 mg/dl Calcium Arsenazo CALA mmol/l 0-18 mg/dl Calcium ocpc CA mmol/l 2-20 μg/ml Carbamazepine CARB μmol/l mg/l Ceruloplasmin CER mg/dl meq/l Chloride CL mmol/l mg/dl Cholesterol CHOL mmol/l SI 3-10 PN A85514AC

41 Linearity Serum/Plasma Analytical Ranges - AU/DxC 700 AU Systems 3 Table 3.6 AU/DxC 700 AU Serum/Plasma Analytical Ranges (Continued) Conventional AU Analytical Ranges Serum/Plasma Chemistry 1-15 ku/l Cholinesterase CHE μkat/l U/L Creatine Kinase CK μkat/l U/L Creatine Kinase MB CKMB μkat/l mg/dl Creatinine CRE μmol/l mg/l C-Reactive Protein CRP mg/dl (OSR6x47) AU400/480/640/680: 0.2 to 160 mg/l AU2700/5400/5800: 0.2 to 80 mg/l CRP High Sensitivity CRPHS AU400/480/640/680: 0.02 to 16 mg/dl AU2700/5400/5800: 0.02 to 8 mg/dl mg/l CRP Normal (OSR6x99) CRPN mg/dl mg/dl Glucose GLU mmol/l μg FEU/mL D-Dimer DDIM μg FEU/mL ng/ml Digoxin DIG nmol/l μg/ml Disopyramide DISO μmol/l μg/ml Ethosuximide SUXI μmol/l ng/ml Ferritin FERR μg/l μg/ml Gentamicin GENT μmol/l U/L Gamma- GGT μkat/l Glutamyltransferase mg/dl Glucose GLU mmol/l mg/dl Haptoglobin HAPT g/l Approximately Hemoglobin A1c HbA1c 2.6 % - highest cal 3.2% to 14.5% a mg/dl HDL Cholesterol HDL-C mmol/l mg/dl Immunoglobulin A IGA g/l mg/dl Immunoglobulin G IGG g/l mg/dl Immunoglobulin M IGM g/l μg/dl Iron IRON μmol/l 2-90 mg/dl Lactate LAC mmol/l U/L Lactate Dehydrogenase LDH μkat/l SI PN A85514AC 3-11

42 Linearity Serum/Plasma Analytical Ranges - AU/DxC 700 AU Systems Table 3.6 AU/DxC 700 AU Serum/Plasma Analytical Ranges (Continued) AU Analytical Ranges Serum/Plasma Chemistry Conventional SI mg/dl LDL Cholesterol LDL-C mmol/l 1-12 μg/ml Lidocaine LIDO μmol/l U/L Lipase LIP μkat/L mmol/l Lithium LI meq/l mg/dl Magnesium MG mmol/l μmol/l Methotrexate MTRX 3x x10-3 mol/l 1-16 μg/ml N-Acetylprocainamide NAPA μmol/l 5-80 μg/ml Phenobarbital PBARB μmol/l μg/ml Phenytoin PHENY μmol/l 1-20 mg/dl Phosphorus (Inorganic) PHOS mmol/l 1-10 meq/l Potassium K 1-10 mmol/l 3-80 mg/dl Prealbumin PALB g/l μg/ml Primidone PRIM μmol/l 1-12 μg/ml Procainamide PROC μmol/l 3-12 g/dl Protein, Total TP g/l μg/ml Quinidine QUIN μmol/l IU/mL Rheumatoid Factor RF IU/mL mg/dl Salicylic Acid SALI μmol/l meq/l Sodium NA mmol/l % T Uptake TUP % μg/ml Theophylline THEO μmol/l μg/dl Thyroxine T nmol/l μg/ml Tobramycin TOB μmol/l mg/dl Transferrin TRF g/l mg/dl Triglyceride TRIG mmol/l mg/dl Urea Nitrogen BUN mmol/l mg/dl Uric Acid UA μmol/l μg/dl Unsaturated Iron Binding Capacity UIBC μmol/l 3-12 PN A85514AC