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INSTAND ICBS GBD 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.

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Präsentation zum Thema: "INSTAND ICBS GBD 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."—  Präsentation transkript:

1 INSTAND ICBS GBD 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 2 Institut für Biotechnologische Diagnostik (GBD), Berlin 3 INSTAND 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 INSTAND ICBS GBD Influenzav. A/H5N1/BTBE VirusRubellavirus Parvovirus B19BSE (PrPsc)Parvovirus B19 Herpes simpl. V. 2Influenzav. A/H5N1/B AgHepatitis E Virus Herpes simpl. V. 1Resp. Sync. V. AgHepatitis D Virus Varicella Zoster V.MumpsvirusHepatitis C Virus CytomegalovirusMeaslesvirusHepatitis B V. Prg. II AdenovirusesHCV GenotypingHerpes simplex V.Hepatitis B V. Prg. I Enterov. (WHO/RKI)Hepatitis C VirusVaricella Zoster V.Hepatitis A Virus EnterovirusesHepatitis B VirusEpstein-Barr VirusHIV-1 p24 Ag HPVHIV-1 (RNA)Cytomegalovirus HIV-1/2 PCR/NATSerology Samples total: > (since 1988) National and WHO International EQASs in Immunology/Virology

3 INSTAND ICBS GBD Partnership for National and International Quality Control Systems in Virus Diagnostics and Safety Testing of Blood CharitéCentrum für diagnostische und präventive Labormedizin Campus 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 ICBS GBD 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 INSTAND ICBS GBD 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 INSTAND ICBS GBD %217April %183November %206April %176November %201April %171November %194April %140November % New participants 156April %103November %102July 1997 Correct results (for 4 samples) ParticipantsDate EQAS for HCV: Qualitative PCR/NAT (1)

7 INSTAND ICBS GBD EQAS for HCV: Qualitative PCR/NAT (2) Results of new participants 91%(48/53) 53 new P 96%(99/103) 103 continuous P divided in 94%(147/156) %(46/53) 53 new P 94%(97/103) 103 continuous P divided in 92%(143/156) Apr %(99/103) %(98/103) 1036Nov %(97/101) %(100/102) 1021Jul Correct resultsParticipants (P)Sample No.Date

8 INSTAND ICBS GBD EQAS for Quantitative PCR/NAT HIV and HCV Good lab performance with robust test: Benefit of EQAS samples run in dublicate in one scheme

9 INSTAND ICBS GBD Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log VirusDateNo. of samples Median (copies/ml) (IU/ml) Number of analyses Results in interval: median +/-0.5 log HIV-1Nov 99-Mrz 07 Nov 02-Mrz , , % (86%-99%) 82% (50%-100%)

10 INSTAND ICBS GBD EQAS for HIV-1: Lab Performance

11 INSTAND ICBS GBD EQAS for HIV-1: Differentiation of Methods

12 INSTAND ICBS GBD Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log * without results for bDNA for samples <200,000 copies/ml (Nov 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) VirusDateNo. of samples Median (copies/ml) (IU/ml) Number of analyses Results in interval: median +/-0.5 log HIV-1Nov 99-Mrz 07 Nov 02-Mrz , , % (86%-99%) 82% (50%-100%) HCV*,& Nov 99-Mrz 07 Apr 00-Mrz ,351, , %*,& (27%-92%) 92% & (63%-100%)

13 INSTAND ICBS GBD EQAS for Quantitative PCR/NAT HBV Training with reliable tests: Benefit of identical EQAS samples for multiple testing

14 INSTAND ICBS GBD Improvement of Lab Performance by 2 Years Training EQAS Nov 04, Nov 05 and Mar 07, HBV PCR/NAT (361) Copies/ml IU/ml

15 INSTAND ICBS GBD Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log # without results for bDNA and hybridization for samples <1,000,000 copies/ml (Nov Apr. 2003) $ without results for hybridization for samples <1,000,000 copies/ml (Nov Apr. 2004) § without results for bDNA for samples <500,000 IU/ml (Apr Apr. 2003) VirusDateNo. of samples Median (copies/ml) (IU/ml) Number of analyses Results in interval: median +/-0.5 log HBV #,$,§ Nov 99-Mrz 07 Nov 01-Mrz ,900-3,084, , % #,$ (52%-91%) 81% § (55%-97%)

16 INSTAND ICBS GBD EQAS for Quantitative PCR/NAT Cytomegalovirus Performance of commercial and in-house tests

17 INSTAND ICBS GBD EQAS for CMV: Quantitative PCR/NAT Date Participants (copies/ml) Correct results Median +/- 1.0 log (positive samples) Correct results Median +/- 0.5 log (positive samples) Nov %20-70% Apr %49-67% Nov %50-75% Apr %69-73% Nov %72-88% Apr %71-76% Nov %71-78% Apr %74-79% Aug %75-79% Nov %70-76% Mar %65-73% May % Sep %72-82% Nov %64-72% Mar %81-88%

18 INSTAND ICBS GBD EQAS: Performance of Commercial and In-house Tests

19 INSTAND ICBS GBD Global Network for External Quality Control and Training External Quality Control (EQASs) EQASs (Germany, Europe, WHO) with >1075 laboratories with all routine tests up to 4-times per year Training 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

20 INSTAND ICBS GBD Contact Hans-Peter Grunert Heinz Zeichhardt CharitéCentrum für diagnostische und präventive Labormedizin Institut für Virologie Campus Benjamin Franklin Hindenburgdamm Berlin Tel.: or 3625 Fax:


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