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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

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INSTAND INSTAND ICBS ICBS GBD GBD

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 Grunert1,2,3, Vanessa Lindig1,3 und Heinz Zeichhardt1,2

1Charité University Medicine Berlin, Campus Benjamin Franklin,

Institute for Virology, Berlin

2INSTAND 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

3Institute for Biotechnological Diagnostic (GBD), Berlin

Collaborating Centers of International Consortium for Blood Safety (ICBS), New York

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INSTAND INSTAND ICBS ICBS GBD GBD

preanalytical phase IQC = internal quality control EQAS =

External Quality Assessment Schemes Scientific - non-for-profit

Scientific societies, health authorities (RKI, PEI), reports, publications, projects, conferences

postanalytical phase

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

Public Health

Diagnosis of patient‘s/ blood donor‘s sample

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INSTAND INSTAND ICBS ICBS GBD GBD

International INSTAND International INSTAND-

  • Network

Network 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

  • "Run" controls
  • daily

National reference materials

  • "Run" controls in coop. with PEI
  • daily

Identical controls for:

  • Diagnostic labs
  • Blood banks
  • Industries
  • Licensing organizations (e.g. PEI)
  • Scientific labs
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INSTAND INSTAND ICBS ICBS GBD GBD

  • (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)

External and Internal Quality Control External and Internal Quality Control Objectives and Benefits Objectives and Benefits

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INSTAND INSTAND ICBS ICBS GBD GBD

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)
  • Paul Ehrlich Institute
  • Robert Koch Institute
  • National and International Reference Institutes
  • Friedrich-Loeffler-Institute
  • World Health Organization, Geneva and Lyon
  • International Consortium for Blood Safety (ICBS), New York

Diagnostic Council

  • f Scientific Societies

DVV and GfV

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INSTAND INSTAND ICBS ICBS GBD GBD INSTAND INSTAND-

  • EQAS Reference Laboratories

EQAS Reference Laboratories

  • 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

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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

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EQAS for EQAS for Quantitative Quantitative PCR/NAT PCR/NAT

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

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EQAS EQAS for HIV for HIV-

  • 1

1: : Test Performance Test Performance

EQAS Nov 2008, HIV PCR/NAT (360)

sample 10114 (median 4,350 = 3.64 log10 copies/ml) Methods

all methods 11 PCR RO 11 PCR ZX 98 TM AB 13 TM RO 13 TM ZX 40 LC ZX 15 bDNA SI

log10 copies/ml

2 3 4 5 6

N 90 N 12 N 1 N 28 N 43 N 1 N 4 N 1 + 0.5 log10

  • 0.5 log10

median + 1.0 log10

  • 1.0 log10
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EQAS EQAS for HIV for HIV-

  • 1

1: : Sample Dilution Series Sample Dilution Series

EQAS Nov 2008, HIV PCR/NAT (360)

all methods (3 samples: dilution factors: 109, 108, 107; 1 sample: neg.) Samples

10113 10114 10115 10116

log10 copies/ml

2 3 4 5 6

N 90

median 2.68 cv 8.59% median 3.64 cv 4.71% neg. sample median 4.58 cv 3.57%

N 90 N 90 N 90

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EQAS for EQAS for Quantitative Quantitative PCR/NAT PCR/NAT

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

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all methods Samples

11053 Nov04 11056 Nov04 11065 Nov05 11086 Mar07

log10 copies/ml

1 2 3 4 5 6

N 29

median 3.92 cv 28.5% median 3.92 cv 28.5% median 3.83 cv 10.9% median 3.92 cv 12.8%

N 48 N 70 N 70

all methods Samples

11053 Nov04 11056 Nov04 11065 Nov05 11086 Mar07

log10 IU/ml

1 2 3 4 5 6

N 71

median 3.25 cv 29.3% median 3.21 cv 33.7% median 3.19 cv 16.0% median 3.24 cv 12.1%

N 82 N 48 N 48

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

1999: 1st International Standard for HBV DNA (97/746) 500,000 IU per vial, genotype A

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INSTAND INSTAND ICBS ICBS GBD GBD

  • 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

Thank you for your attention Thank you for your attention