Multichem Infectious Disease QC

Transcription

1 Infectious Disease QC

2 Contents Introduction....3 Quality Control in the Laboratory...4 Infectious Disease (ID) QC....5 Ready-to-use Concept....6 NRL...7 QConnect...8 IAMQC in Collaboration with QConnect ID Multi-Marker Range Multchem IDBlue Multchem IDYellow Multchem IDPurple Multchem IDRed Multchem IDOrange Multchem IDSeroNeg Multchem IDHEPR Multchem IDHEPA Multchem IDHEPV Multchem IDToRCH G Multchem IDToRCH M ID Single Marker Range Multchem IDHIV p Multchem IDHIV

3 MULTICHEM INFECTIOUS DISEASE QC Introduction Technopath Clinical Diagnostics (Technopath) is an Irish company driven by innovation with a mission to become the global leader in test-consolidated third party quality control materials and real-time peer review and QC data management software solutions. We aim to support clinical laboratories to operate more efficiently while improving the quality of patient test results. We operate in the in vitro diagnostics (IVD) sector. Our business is focused on four core elements: Human based quality control material for clinical laboratories Quality control software and data management solutions IAMQC Proficiency testing software and sera - Proficiency testing solutions High quality IVD raw materials IVD Raw Materials Company Timeline Founded in 2004 Technopath Clinical Diagnostics has a track record of achievement driven by our customer focus. We constantly challenge ourselves through our products to improve the efficiency, compliance and cost effectiveness of clinical laboratories while improving the accuracy and quality of patient test results. Multichem ID TECHNOPATH DISTRIBUTION FOUNDED TECHNOPATH CLINICAL DIAGNOSTICS FOUNDED AS R&D COMPANY FIRST PRODUCT LAUNCHED SIGN GLOBAL CONTRACT WITH ABBOTT US FDA 510K APPROVALS IA & Chemistry PRODUCTS NOW SOLD IN 120 COUNTRIES GLOBALLY MULTICHEM ID SEROLOGY QC 3

4 MULTICHEM INFECTIOUS DISEASE QC Quality Control in the Laboratory The requirement for an internal QC program is an integral part of compliance based on International accreditation standards. This is simply stated but involves considerable thought and planning on the part of a laboratory. QC strategy begins with a definition of the character of QC material to be employed and the decision making process in a laboratory. Regulations often provide plenty of general information on quality control, but may not always offer specific guidance regarding quality control, especially for infectious disease testing. Without this specific guidance, laboratories may unknowingly perform the minimum amount of quality control or use only the manufacturer provided (in-kit) controls. All competent laboratories understand the critical nature of infectious disease testing and the implications for patient care in reporting false positive or false negatives results. Establishing an internal QC system that incorporates independent third party controls and comprehensive data management such as EDCNet will help assure the quality and reliability of infectious disease testing while providing increased confidence in reported patient test results. Control material may be provided by the instrument manufacturer or by an independent control manufacturer. The control materials provided by the manufacturer of the instrument or reagents are often referred to as in kit controls. The control materials provided by an independent manufacturer are often referred to as third party controls. The term third party is used to describe a quality control product that helps provide an independent assessment of a diagnostic device or method. Third party controls are manufactured independently of the test system calibrators and reagents. Such controls generally begin with a human based matrix that helps provide a product analogous to a patient sample. Third party controls with a longer shelf life allow use of the same control lot over multiple changes in reagents and calibrators, giving the laboratory the ability to detect shifts that may occur with new reagents or calibrators. ID control users that participate in EDCNet will be able to identify shifts between reagent lots as the same control lot of Multichem ID control material will be used across multiple reagent lots. 4

5 MULTICHEM INFECTIOUS DISEASE QC Infectious Disease (ID) QC Multichem ID Technopath s Multichem Infectious Disease (ID) Quality Controls (QC) samples, have been specifically optimised and validated to match assays commonly used for infectious diseases testing. These QC samples have been designed to react at an appropriate level within a relevant analytical range of various assays. Multichem ID QC samples are registered IVD s manufactured in an ISO facility and, where applicable, are standardised against the WHO international standards leading to traceability claims, consistent with ISO Multichem ID QC samples are ready-to-use and are bar-coded to ensure traceability. For convenience, the Multichem ID Multi-marker range of products is easily identifiable by their colour coding. Globally, a single batch of each Multichem ID QC sample is available, allowing Multichem ID participants using the same assay to compare their QC results. Easy handling & highly efficient The Multichem ID QC catalogue offers a selection of QC samples for clinical and blood screening laboratories performing serology for a range of infectious diseases. Simply locate the assay currently in use and select the appropriately matched QC. Multichem ID QC Samples can be ordered at info@technopathcd.com 5

6 MULTICHEM INFECTIOUS DISEASE QC Ready-to-use Concept Technopath Clinical Diagnostics ready-to-use concept means that Multichem ID control vials can be placed directly on the instrument specific sample/control carriers for testing without the need for aliquoting into sample cups on a daily basis. This ready to-use concept simplifies the handling process which reduces errors, leads to less dead volume and overall wastage. Once opened, the controls are stable for 90 days, provided they are capped after each use and returned to 2-8ºC for storage. Multichem ID Controls can remain in the instrument specific sample/control carriers for this time period for ease of handling. Instrument specific barcodes are also supplied with the vials for ease of programming and identification on the instrument. Advantages: Ready-to-use liquid stable No requirements for sample aliquoting Direct sampling from control vials Direct control sample placement and storage on instrument specific carriers Elimination of QC sample transposition errors Increased compliance with health and safety guidelines Instrument specific barcodes included 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 6

7 MULTICHEM INFECTIOUS DISEASE QC Technopath s Multichem ID Serology Quality Controls have been developed in conjunction with NRL, Australia. NRL was established in 1985 as part of the Australian Government s HIV/AIDS Strategy, to evaluate HIV tests and adjudicate on the interpretation of HIV test results. Today, NRL remains a not-forprofit scientific organisation that exists for the benefit of the public. Its overall goal is to support laboratories, in Australia and internationally, that perform testing for the diagnosis and management of human infectious disease. NRL is designated a WHO Collaborating Centre for Diagnostics and Laboratory Support for HIV and AIDS and Other Bloodborne Infections. NRL was established in 1985 as part of the Australian Government s HIV/AIDS Strategy, to evaluate HIV tests and adjudicate on the interpretation of HIV test results. Today, NRL remains a not-for-profit scientific organisation that exists for the benefit of the public. Mission: To promote the quality of tests and testing for infectious diseases globally. Goals: NRL seeks to ensure that laboratory results for infectious diseases are of high quality by providing: Comprehensive and innovative quality assurance services; Evaluations of tests and test algorithms; Specialised laboratory testing services; Training with sustainable outcomes; Consultation and advice on policy relating to laboratory testing. 7

8 MULTICHEM INFECTIOUS DISEASE QC QConnect QConnect is a completely integrated and simplified QC solution. QConnect includes; results management and reporting through EDCNet, QC limits, Uncertainty of Measurement (MU) reports, troubleshooting and the ability to liaise with other users and experts through the questions and answers and reference materials section - all streamlined into a single online portal called QConnect. We ve made QC easy. QConnect Limits take advantage of peer data sharing and provide users robust, pre-determined control limits. QC limits are based on up to 10 years of QC data and are available for commonly used QC sample/assay combinations. These statistically validated QC limits give you the confidence to know immediately when your system is not running to specification. What are QConnect Limits? Traditional QC approaches used to determine QC limits have been derived or modified from clinical chemistry and may not be applicable to serology or NAT. QConnect Limits, developed by NRL, utilise historical data by determining expected upper and lower values of results for each QC sample/assay combination. All Multichem ID users using the same assay and the same lot of QC material submit results to EDCNet. Over time, multiple lots of QC materials have been tested by many laboratories, operators and instruments across numerous lots of reagents. These results reflect the expected extent of variation for that QC sample/assay combination. These results have been extracted and analysed in collaboration with a biostatistician. The variation of QC results, both within each QC lot and between each QC lot was used to determine an upper and lower limit for each QC sample/ assay combination. These limits allows for the identification of any unexpected QC result, potentially identifying unacceptable variation from a range of sources including reagent lot numbers; instruments or equipment calibration and maintenance; operator errors; assay and QC sample storage and transport or environmental conditions. How to use QConnect Limits When entering data into EDCNet, results outside the QConnect Limits for that QC sample/assay combination are flagged in red indicating further investigation is required. All results outside the QConnect Limits are held in quarantine until they are validated by an NRL staff member. Participants can overlay the QConnect Limits on Levey-Jennings and other EDCNet charts in conjunction with laboratory-specific and peer group limits. NRL also provides a suggested approach, including a check list, for the investigation and troubleshooting of unexpected results. Note: QConnect QC samples are used in addition to the manufacturers controls and as such, the 8

9 MULTICHEM INFECTIOUS DISEASE QC manufacturers instructions for validating an assay should be adhered to. For further information regarding QConnect Limits please refer to: Measurement of Uncertainty(MU) Reports To fulfil regulatory requirements with ease, you can access free annual MU reports specific for your laboratory. NRL has developed a method for estimating and reporting MU for quantitative assays based on a comparison of your laboratory s QC results with those reported by other laboratories using the same QC sample/assay combination (peer group). The methodology for determining MU is published and scientifically validated. The MU estimation accounts for the assay s imprecision (random error) and bias (systematic error). For further information regarding MU reports please refer to: Questions and Answers The QConnect portal provides you with a repository of information including frequently asked questions about the usage, storage, testing or troubleshooting of results obtained from your QC sample. If you can t find the answers there, additional questions can always be directed to qconnect@nrl.gov.au Reference Materials We know you don t have time to spend countless hours searching for information. QConnect also supplies a list of relevant literature about QC for infectious diseases testing including Journal Publications Presentations Investigations and Case Studies Laboratory Standards and Requirements Please refer to: Contact Members QConnect is your gateway to a QC community and allows you to access advice from your peers, NRL staff and other experts in the field, wherever you are in the world. Support at Your Fingertips NRL provides scientific and technical support to all QConnect and EDCNet users. All data outside the QConnect Limits are reviewed on a daily basis by NRL staff. As part of the personalised QConnect service, NRL staff are available to perform detailed investigations into unusual QC results, liaise with assay manufacturers and issue written reports. 9

10 MULTICHEM INFECTIOUS DISEASE QC IAMQC in collaboration with QConnect Designed to complement and support Technopath Clinical Diagnostics Quality Control (QC) product range, IAMQC Software provides laboratory managers and technologists with a range of QC software tools to analyse their QC results in real-time. With Multichem ID Quality Controls, IAMQC has collaborated with EDCNet, an internet-based software program specifically designed for monitoring serology results. EDCNet allows for the simple collection, management and analysis of QC data in real-time. Access to this multilingual software is free when purchasing Multichem ID QC samples. Users can log in to EDCNet through Technopath s IAMQC software anywhere around the world, at any time. Once registered, Multichem ID users can access EDCNet by logging in with a username and password. The anonymity of all participants is protected by a unique laboratory code. EDCNet has security systems similar to that used for internet banking, is supported by all major internet browsers and requires no software installation. Multichem ID users who use EDCNet can share QC data to assess the accuracy and precision of their assays. All Multichem ID products are automatically set up in EDCNet. Users can edit or delete data as required. There is no requirement to back up data as EDCNet can be interfaced with individual Laboratory Information Systems or instrumentation. EDCNet functionality is designed for all levels of users. Basic users can set up EDCNet and walk away, having automated alerts and reports sent directly to their address. Power users can take advantage of the advanced inbuilt QC analysis functions to identify and investigate trends and shifts in QC results. Customised QC reports, providing real-time review of results in a Levey-Jennings or Mean/Scatter graphical or tabular format, can be sent directly to each Multichem ID user by or saved as a PDF. EDCNet can be programmed to automatically schedule the delivery of your customised report on a weekly or monthly basis. EDCNet also has a network option that allows a group of laboratories to track trends and compare QC test results across all laboratories within that network. 10

11 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDBlue Available Early 2018 Multichem IDBlue Positive Control 4 x 5mL 4 x 5mL SR101b Negative Control Positive Control 2 x 5mL 2 x 5mL 4 x 5mL SR102b Multichem IDBlue - Analyte List Anti-HIV IgG Anti-HCV IgG Anti-HBc IgG HBsAg Anti-HTLV IgG Anti-Treponema Pallidum IgG Multichem IDBlue Analyser Systems MANUFACTURER SYSTEM ASSAY NAME Anti-HBc II CMIA Anti-HCV CMIA Abbott DiaSorin DiaSorin ARCHITECT LIAISON LIAISON XL MUREX HBsAg Qualitative II CMIA HIV Ag/Ab Combo CMIA rhtlv-i/ii CMIA Syphilis TP CMIA Anti-HBc CLIA Treponema Screen CLIA HBsAg Quant CLIA HCV Ab CLIA HIV Ab/Ag CLIA rechtlv-i/ii CLIA 11

12 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDYellow Multichem IDYellow Positive Control 4 x 5mL 4 x 5mL SR111y Negative Control Positive Control 2 x 5mL 2 x 5mL 4 x 5mL SR112y Multichem IDYellow - Analyte List Anti-HIV IgG Anti-HCV IgG Anti-HBc IgG Anti-HTLV IgG Anti-Treponema IgG HBsAg Multichem IDYellow - Analyser Systems MANUFACTURER SYSTEM ASSAY NAME HBcore ChLIA HBsAg ChLIA Abbott PRISM HCV ChLIA HIV O Plus ChLIA HTLV-I/HTLV-II ChLIA 12

13 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDPurple Available Early 2018 Multichem IDPurple Positive Control 4 x 5mL 4 x 5mL SR121p Negative Control Positive Control 2 x 5mL 2 x 5mL 4 x 5mL SR122p Multichem IDPurple - Analyte List Anti-HIV IgG Anti-HCV IgG Anti-HBc IgG Anti-HTLV IgG Anti-Treponema IgG HBsAg Multichem IDPurple - Analyser Systems MANUFACTURER SYSTEM ASSAY NAME HBcore ChLIA HBsAg ChLIA ABBOTT PRISM HCV ChLIA HIV Ag/Ab Combo ChLIA HTLV-I/HTLV-II ChLIA 13

14 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDRed Multichem IDRed Positive Control 4 x 5mL 4 x 5mL SR131r Negative Control Positive Control 2 x 5mL 2 x 5mL 4 x 5mL SR132r Multichem IDRed - Analyte List Anti-HIV IgG Anti-HCV IgG Anti-HBc IgG Anti-HTLV IgG Anti-Treponema IgG HBsAg Multichem IDRed - Analyser Systems MANUFACTURER SYSTEM ASSAY NAME Anti-HBc ECLIA Anti-HCV II ECLIA ROCHE ELECSYS COBAS HBsAg II ECLIA HIV Combi ECLIA HIV Combi PT ECLIA Syphilis ECLIA 14

15 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDOrange Multichem IDOrange Positive Control 4 x 5mL 4 x 5mL SR141o Negative Control Positive Control 2 x 5mL 2 x 5mL 4 x 5mL SR142o Multichem IDOrange - Analyte List Anti-HIV IgG Anti-HCV IgG Anti-HBc IgG Anti-HTLV IgG Anti-Treponema IgG HBsAg Multichem IDOrange - Analyser Systems MANUFACTURER SYSTEM ASSAY NAME Centaur HBsAgII ChLIA Centaur HCV ChLIA SIEMENS ADVIA Centaur HIV Ag/Ab Combo (CHIV) ChLIA Centaur HIV 1/0/2 Enhanced (EHIV) ChLIA Centaur Syphilis (SYPH) ChLIA 15

16 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDSeroNeg 36 month sealed vial stability at 2 C to 8 C. Multichem IDSeroNeg Negative Control 4 x 1mL 4 x 1mL SR010z Multichem IDSeroNeg - Analyte List Anti-HIV Anti-HCV Anti-HBc Anti-HTLV Anti-Treponema HBsAg Anti-CMV HIV p24 IDHEPR Multichem IDHEPR Positive Control 4 x 2.5mL 4 x 2.5mL SR201n Multichem IDHEPR - Analyte List Anti-HBs IgG Anti-HBe IgG Anti-HAV IgG Anti-HEV IgG 16

17 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDHEPA Multichem IDHEPA Positive Control 4 x 2.5mL 4 x 2.5mL SR211n Multichem IDHEPA - Analyte List HBeAg Anti-HBc IgM Anti-HAV IgM Anti-HEV IgM IDHEPV Multichem IDHEPV Positive Control 4 x 2.5mL 4 x 2.5mL SR221n Multichem IDHEPV - Analyte List Anti-HBs IgG Anti-HAV IgG 17

18 MULTICHEM INFECTIOUS DISEASE QC MULTI-MARKER RANGE IDToRCH G Multichem IDToRCH G Positive Control 4 x 2.5mL 4 x 2.5mL SR301n Negative Control Positive Control 2 x 2.5mL 2 x 2.5mL 4 x 2.5mL SR302n Multichem IDToRCH G - Analyte List Anti-Rubella IgG Anti-Toxoplasma IgG Anti-CMV IgG Anti-EBV VCA IgG Anti-EBV EBNA IgG Anti-HSV 1 IgG Anti-HSV 2 IgG IDToRCH M Multichem IDToRCH M Positive Control 4 x 2.5mL 4 x 2.5mL SR311n Negative Control Positive Control 2 x 2.5mL 2 x 2.5mL 4 x 2.5mL SR312n Multichem IDToRCH M - Analyte List Anti-Rubella IgM Anti-Toxoplasma IgM Anti-CMV IgM Anti-EBV VCA IgM Anti-HSV 1 IgM Anti-HSV 2 IgM 18

19 MULTICHEM INFECTIOUS DISEASE QC SINGLE ANALYTE RANGE IDHIV p24 Multichem IDHIV p24 Positive Control 4 x 2.5mL 4 x 2.5mL SR401n Multichem IDHIV p24 - Analyte List HIV-1 p24 Antigen IDHIV 2 Multichem IDHIV 2 Positive Control 4 x 2.5mL 4 x 2.5mL SR411n Multichem IDHEPV - Analyte List Anti-HIV-2 19

20 Tel: Fax: Technopath Life Sciences Park, Fort Henry, Ballina, Co. Tipperary, Ireland. Technopath Clinical Diagnostics All details correct at time of print. Photgraphs are for illustration purposes only. E & O.E. MM_MultichemIDBrochure_Digi_R3