The Role of External Quality Assessment Schemes The Role of External Quality Assessment Schemes for Laboratory Proficiency and Standardization for Laboratory Proficiency and Standardization Hans-Peter Grunert 1,2,3 , Vanessa Lindig 1,3 und Heinz Zeichhardt 1,2 1 Charité University Medicine Berlin, Campus Benjamin Franklin, Institute for Virology, Berlin 2 INSTAND e.V. - Society for Promotion of Quality Assurance in Medical Laboratories e.V., WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine, Düsseldorf 3 Institute for Biotechnological Diagnostic (GBD), Berlin Collaborating Centers of International Consortium for Blood Safety (ICBS), New York GBD GBD INSTAND ICBS INSTAND ICBS
The Role of EQC and IQC for Public Health and The Role of EQC and IQC for Public Health and Quality Improvement of Diagnostics and Blood Safety Quality Improvement of Diagnostics and Blood Safety EQAS = External Quality Assessment preanalytical Schemes Scientific - non-for-profit phase Scientific societies, health authorities (RKI, PEI), reports, publications, projects, conferences Public Health Diagnosis of patient‘s/ blood donor‘s sample IQC = postanalytical internal phase quality control GBD GBD INSTAND ICBS INSTAND ICBS
International INSTAND- -Network Network International INSTAND for External and Internal Quality Control for External and Internal Quality Control External Quality Control (EQASs) • EQASs (Germany, Europe, WHO) with >1100 laboratories with all routine tests • 2 to 4 times per year Internal Quality Control Surplus samples from EQASs National reference materials • "Run" controls • "Run" controls in coop. with PEI • daily • daily Identical controls for: Diagnostic labs • Blood banks • Industries • Licensing organizations (e.g. PEI) • Scientific labs • GBD GBD INSTAND ICBS INSTAND ICBS
External and Internal Quality Control External and Internal Quality Control Objectives and Benefits Objectives and Benefits • (Self) control of laboratories -> proficiency • Training • Recognition of test immanent problems -> post-marketing surveillance • Examination of suitability of different test principles • Pre-warning system for detecting problems • Standardization • Improvement of quality • Development of control samples • Element of accreditation (ISO 15189) GBD GBD INSTAND ICBS INSTAND ICBS
Partnership for National and Partnership for National and International Quality Control Systems International Quality Control Systems in Virus Diagnostics and Safety Testing of Blood in Virus Diagnostics and Safety Testing of Blood • Charité University Medicine Berlin, Campus Benjamin Franklin, Institute for Virology • INSTAND - Society for Promotion of Quality Assurance in Medical Laboratories e.V., Duesseldorf Reference Institute of German Medical Association (Bundesärztekammer) WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine • Gesellschaft für Biotechnologische Diagnostik (GBD), Berlin • German Medical Association (Bundesärztekammer) • German Association against Virus Diseases (DVV) • Society of Virology (GfV) Diagnostic Council • Paul Ehrlich Institute of Scientific Societies • Robert Koch Institute DVV and GfV • National and International Reference Institutes • Friedrich-Loeffler-Institute • World Health Organization, Geneva and Lyon • International Consortium for Blood Safety (ICBS), New York GBD GBD INSTAND ICBS INSTAND ICBS
INSTAND- -EQAS Reference Laboratories EQAS Reference Laboratories INSTAND • A. Baillot Niedersächsisches Landesgesundheitsamt, Hannover • S. Diedrich Robert Koch-Institut, Berlin; NRZ Poliomyelitis und Enteroviren Regionales Referenzlabor der WHO/EURO für Poliomyelitis • H.W. Doerr / H. Rabenau / A. Berger / R. Allwinn Universitätsklinikum Frankfurt • G. Enders Labor Enders, Stuttgart • B. Fleckenstein / K. Korn Universitätsklinikum Erlangen; NRZ Retroviren • W. Gerlich / W.R. Willems Universität Gießen; Konsiliarlab. HBV und HDV • E. Grünelt, M. Loehr, A. Vornwald DRK-Blutspendedienst Ost, Cottbus • S. Günther Bernhard-Nocht-Institut, Hamburg • W. Jilg Universität Regensburg; Konsiliarlab. HAV und HEV • A. Karl / K. Gubbe DRK-Blutspendedienst Ost, Plauen • D. Krüger / J. Hofmann Charité Universitätsmedizin Berlin, CCM; Konsiliarlab.Hantaviren • C. Kücherer Robert Koch-Institut, Berlin • U.G. Liebert Universität Leipzig • A. Mankertz Robert Koch-Institut, Berlin; NRZ Masern, Mumps und Röteln • T. Mertens / D. Michel Universitätsklinikum Ulm; Konsiliarlab.CMV • N. Müller-Lantzsch / B. Gärtner Universitätsklinikum des Saarlandes; Konsiliarlab.EBV, HHV 6, 7, 8 • D. Neumann-Haefelin / D. Huzly / M. Panning Universitätsklinikum Freiburg • S. Nick / H. Scheiblauer Paul-Ehrlich-Institut, Langen; Prüflabor für IVD • M. Nübling / M. Chudy Paul-Ehrlich-Institut, Langen • H. Pfister / U. Wieland / R. Kaiser Uniklinik Köln; Konsiliarlab. Polyomaviren • T. Rogge Vivantesklinikum, Berlin-Neukölln • M. Roggendorf / S. Ross Universitätsklinikum Essen; NRZ HCV • T. Schulz / A. Heim Medizinische Hochschule Hannover; Konsiliarlab. Adenoviren • B. Schweiger Robert Koch-Institut, Berlin; NRZ Influenza • P. Wutzler Universitätsklinikum Jena; Konsiliarlab. HSV und VZV GBD GBD INSTAND ICBS INSTAND ICBS
National and WHO International EQASs National and WHO International EQASs in Virus Immunology and Genome Detection in Virus Immunology and Genome Detection Serology and Antigen Detection Virus Genome Detection and Typing HIV-1/2 Epstein-Barr virus HIV-1 (RNA) 33,838 samples, since ´97 HIV-1 p24 Herpes simplex viruses Hepatitis B Virus 31,820 samples, since ´97 Hepatitis A virus Varicella zoster virus Hepatitis C Virus 49,392 samples, since ´97 Hepatitis B virus, Prg. I Measlesvirus HCV-genotyping 1,671 samples, since ´06 Hepatitis B virus, Prg. II Mumpsvirus Hepatitis C virus Resp. Sync. Virus Ag Hepatitis A Virus Influenza A/H5N1/B Hepatitis D virus Influenza A/H5N1/B Ag Parvovirus B19 Enteroviruses Hepatitis E virus TBE Virus Cytomegalovirus Enterovirus (WHO/RKI) Rubellavirus Hantavirus Epstein-Barr virus Hum. Papillomaviruses Parvovirus B19 BSE (PrPsc) Herpes simplex viruses Adenoviruses Cytomegalovirus Varicella zoster virus Resp. Sync. Virus Planned: HIV resistance testing Cooperation of NRZ Retroviruses (Erlangen) and GfV/DVV and INSTAND GBD GBD INSTAND ICBS INSTAND ICBS
EQAS for Quantitative Quantitative PCR/NAT PCR/NAT EQAS for HIV HIV � Good lab performance � Good lab performance with robust tests: with robust tests: Comparison of different tests and Comparison of different tests and quantification in dilution series quantification in dilution series GBD GBD INSTAND ICBS INSTAND ICBS
EQAS for HIV for HIV- -1 1: : Test Performance Test Performance EQAS EQAS Nov 2008, HIV PCR/NAT (360) sample 10114 (median 4,350 = 3.64 log 10 copies/ml) 6 5 + 1.0 log 10 log 10 copies/ml + 0.5 log 10 4 median - 0.5 log 10 3 - 1.0 log 10 N 1 N 43 N 1 N 4 N 90 N 12 N 28 N 1 2 all methods 11 PCR RO 11 PCR ZX 98 TM AB 13 TM RO 13 TM ZX 40 LC ZX 15 bDNA SI Methods GBD GBD INSTAND ICBS INSTAND ICBS
EQAS for HIV for HIV- -1 1: : Sample Dilution Series Sample Dilution Series EQAS EQAS Nov 2008, HIV PCR/NAT (360) all methods (3 samples: dilution factors: 10 9 , 10 8 , 10 7 ; 1 sample: neg.) 6 median median neg. median 2.68 3.64 sample 4.58 cv cv cv 8.59% 4.71% 3.57% 5 log 10 copies/ml 4 3 N 90 N 90 N 90 N 90 2 10113 10114 10115 10116 Samples GBD GBD INSTAND ICBS INSTAND ICBS
EQAS for Quantitative Quantitative PCR/NAT PCR/NAT EQAS for HBV HBV � Training with reliable tests � Training with reliable tests Standardization Standardization Benefit of identical EQAS samples Benefit of identical EQAS samples for multiple testing for multiple testing GBD GBD INSTAND ICBS INSTAND ICBS
Improvement of Lab Performance Improvement of Lab Performance by 2 Years Training by 2 Years Training EQAS Nov 04, Nov 05 and Mar 07, HBV PCR/NAT (361) Copies/ml IU/ml all methods all methods 6 6 median median median median median median median median 3.92 3.92 3.83 3.92 3.25 3.21 3.19 3.24 cv cv cv cv cv cv cv cv 28.5% 28.5% 10.9% 12.8% 5 5 29.3% 33.7% 16.0% 12.1% 4 4 log 10 copies/ml log 10 IU/ml 3 3 2 2 1 1 N 48 N 48 N 82 N 71 N 70 N 70 N 48 N 29 0 0 11053 Nov04 11056 Nov04 11065 Nov05 11086 Mar07 11053 Nov04 11056 Nov04 11065 Nov05 11086 Mar07 Samples Samples 1999: 1 st International Standard for HBV DNA (97/746) 500,000 IU per vial, genotype A GBD GBD INSTAND ICBS INSTAND ICBS
Thank you for your attention Thank you for your attention Dr. Hans-Peter Grunert Prof. Dr. Heinz Zeichhardt CharitéCentrum für diagnostische und präventive Labormedizin Institut für Virologie Campus Benjamin Franklin Hindenburgdamm 27 12203 Berlin Tel.: +49-30-8445 3624 or 3625 Fax: +49-30-8445 3626 Email: Hans-Peter.Grunert@charite.de Web: www.instandev.de GBD GBD INSTAND ICBS INSTAND ICBS
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