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H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3

EQASs for TTI Diagnostics as Tool for Elucidating and Solving Problems of Commercial and In-house Tests. H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3 1 CharitéCentrum für diagnostische und präventive Labormedizin, Institut für Virologie, Campus Benjamin Franklin, Berlin

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H. Zeichhardt 1,3 , V. Lindig 1,2 and H.-P. Grunert 1,2,3

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  1. EQASs for TTI Diagnosticsas Tool for Elucidating and Solving Problemsof Commercial and In-house Tests H. Zeichhardt1,3, V. Lindig1,2 and H.-P. Grunert1,2,3 1CharitéCentrum für diagnostische und präventive Labormedizin, Institut für Virologie, Campus Benjamin Franklin, Berlin 2Institut für Biotechnologische Diagnostik (GBD), Berlin 3INSTAND e.V., Düsseldorf Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien Collaborating Centers of International Consortium for Blood Safety (ICBS), New York Koch-Metchnikov-Forum of the Petersburg Dialogue

  2. Serology PCR/NAT HIV-1/2 Cytomegalovirus HIV-1 (RNA) HPV HIV-1 p24 Ag Epstein-Barr Virus Hepatitis B Virus Enteroviruses Hepatitis A Virus Varicella Zoster V. Hepatitis C Virus Enterov. (WHO/RKI) Hepatitis B V. Prg. I Herpes simplex V. HCV Genotyping Adenoviruses Hepatitis B V. Prg. II Measlesvirus Cytomegalovirus Hepatitis C Virus Mumpsvirus Varicella Zoster V. Hepatitis D Virus Resp. Sync. V. Ag Herpes simpl. V. 1 Hepatitis E Virus Influenzav. A/H5N1/B Ag Herpes simpl. V. 2 Rubellavirus TBE Virus Influenzav. A/H5N1/B Parvovirus B19 BSE (PrPsc) Parvovirus B19 National and WHO International EQASsin Immunology/Virology Samples total: > 702.000 (since 1988)

  3. Partnership for National andInternational Quality Control Systems in Virus Diagnostics and Safety Testing of Blood • CharitéCentrum für diagnostische und präventive LabormedizinCampus Benjamin Franklin, Institut für Virologie, Berlin • Institute for Standardization and Documentation in Medical Laboratories (INSTAND), Düsseldorf WHO Collaborating Center for Quality Assurance and Standardization in Laboratory Medicine • Institut für Biotechnologische Diagnostik der 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 of DVV and GfV

  4. INSTAND EQAS - Reference Laboratories • Prof. Braun / Prof. Enders, Stuttgart • Prof. Doerr / Prof. Rabenau / Dr. Berger, Frankfurt • Prof. Fleckenstein / Dr. Huber / Dr. Korn, Erlangen • Prof. Gerlich / Dr. Willems, Gießen • Prof. Gürtler, Greifswald • Dr. Heckler, Hannover • Dr. Heim, Hannover • Prof. Klenk / Prof. Radsak, Marburg • Prof. Krüger / Dr. Meisel / Dr. Hofmann, Berlin • Prof. Kurth / Prof. Pauli / Prof. Schreier / Dr. Mankertz / Dr. Schweiger / Dr. Tischer, RKI, Berlin • Prof. Liebert / Prof. Pustowoit, Leipzig • Prof. Löwer / Dr. Chudy / Dr. Nick / Dr. Nübling / Dr. Scheiblauer / Dr. Unger, PEI, Langen • Prof. Mettenleiter / Prof. Groschup / Dr. Buschmann / PD Dr. Harder / Dr. Ziegler, FLI, Greifswald - Insel Riems • Prof. Müller-Lantzsch / Dr. Gärtner, Homburg/Saar • Prof. Neumann-Haefelin / Dr. Huzly, Freiburg • Prof. Pfister / Dr. Wieland, Köln • Prof. Roggendorf / PD Dr. Ross / Dr. Fiedler, Essen • Dr. Vornwald, Berlin • Prof. Wutzler / Prof. Faber / Dr. Sauerbrei, Jena

  5. EQAS for Qualitative PCR/NAT HCV Detection and solving of performance problems Problems: • False negative results in inexperienced laboratories Consequences: • EQAS surplus samples for daily run controls and training

  6. Date Participants Correct results (for 4 samples) July 1997 102 96-100% November 1997 103 95-100% April 1998 156 92-99% New participants November 1998 140 98-100% April 1999 194 98-100% November 1999 171 98-99% April 2000 201 99-100% November 2000 176 99-100% April 2001 206 99% November 2001 183 99-100% April 2002 217 99-100% EQAS for HCV: Qualitative PCR/NAT (1)

  7. Date Sample No. Participants (P) Correct results Jul. 1997 1 102 98% (100/102) 4 101 95% (97/101) Nov. 1997 6 103 95% (98/103) 7 103 96% (99/103) Apr. 1998 12002 156 92% (143/156) divided in 103 continuous P 94% (97/103) 53 new P 87% (46/53) 12004 156 94% (147/156) divided in 103 continuous P 96% (99/103) 53 new P 91% (48/53) EQAS for HCV: Qualitative PCR/NAT (2) Results of new participants

  8. EQAS for Quantitative PCR/NAT HIV and HCV Good lab performancewith robust test:Benefit of EQAS samples run in dublicate in one scheme

  9. Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log

  10. EQAS for HIV-1: Lab Performance

  11. EQAS for HIV-1: Differentiation of Methods

  12. Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log * withoutresultsfor bDNA forsamples <200,000 copies/ml (Nov. 1999 - Nov. 2000) & without results for bDNA for samples <3,000 copies/ml (Apr. 2004; Mrz. 2007) without results for bDNA for samples <1,220 IU/ml (Apr. 2004; Mrz 2007)

  13. EQAS for Quantitative PCR/NAT HBV Training with reliable tests:Benefit of identical EQAS samplesfor multiple testing

  14. Improvement of Lab Performanceby 2 Years Training EQAS Nov 04, Nov 05 and Mar 07, HBV PCR/NAT (361) IU/ml Copies/ml

  15. Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log # withoutresultsfor bDNA andhybridizationforsamples <1,000,000 copies/ml (Nov. 1999 - Apr. 2003) $ without results for hybridization for samples <1,000,000 copies/ml (Nov. 2003 - Apr. 2004) § without results for bDNA for samples <500,000 IU/ml (Apr. 2002 - Apr. 2003)

  16. EQAS for Quantitative PCR/NATCytomegalovirus  Performance ofcommercial and in-house tests

  17. EQAS for CMV: Quantitative PCR/NAT

  18. EQAS: Performance ofCommercial and In-house Tests

  19. Global Network for External Quality Control and Training

  20. Contact Hans-Peter Grunert 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 Heinz.Zeichhardt@charite.de

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