The Impact of International Standard Materials on Correct Test Results: Experiences from EQASs for HIV, HCV, HBV and BSE H.-P. Grunert 1,2, K.-O. Habermehl.

Präsentation zum Thema: "The Impact of International Standard Materials on Correct Test Results: Experiences from EQASs for HIV, HCV, HBV and BSE H.-P. Grunert 1,2, K.-O. Habermehl."—  Präsentation transkript:

1 The Impact of International Standard Materials on Correct Test Results: Experiences from EQASs for HIV, HCV, HBV and BSE H.-P. Grunert 1,2, K.-O. Habermehl 1,2 and H. Zeichhardt 1,3 1 Charité University Medicine Berlin, Campus Benjamin Franklin, Institute for Infektious Diseases Medicine, Dept. Virology, Berlin 2 Institute for Biotechnological Diagnostics (GBD), Berlin 3 Institute for Standardization and Documentation in Medical Laboratory (INSTAND), Düsseldorf Collaborating Centers of International Consortium for Blood Safety (ICBS), New York

2 Grunert, SoGAT, Paris, 2004 2 Quantitative Genome Detection of HCV, HIV and HBV by PCR/NAT Introduction of new quality criteria: Threshold value:Median +/- 1.0 log 10 Intended interval:Median +/- 0.5 log 10

3 Grunert, SoGAT, Paris, 2004 3 Apr 2003 HCV sample 12044 Median: 3,710 copies/ml*; 2,395 IU/ml 90% +0.5 log -0.5 log Median 67% +0.5 log -0.5 log Median N copies/ml = 21 N total = 141 N IU/ml = 120

4 Grunert, SoGAT, Paris, 2004 4 Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log * without results for bDNA for samples <200,000 copies/ml (Nov. 1999 - Nov. 2000) & without results for bDNA for samples <3,000 copies/ml (Apr. 2004) without results for bDNA for samples <1,200 IU/ml (Apr. 2004) VirusDateNo. of samples Median (copies/ml) (IU/ml) Number of analyses Results in interval: median +/-0.5 log HCV*,& Nov 99-Apr 04 Apr 00-Apr 04 29 26 3,000-1,351,000 1,200-400,000 1050 2319 80%*,& (67%-86%) 93% & (85%-100%)

5 Grunert, SoGAT, Paris, 2004 5 Apr 2003 HIV sample 10041 Median: 721 copies/ml*; 650 IU/ml 67% +0.5 log -0.5 log Median 90% +0.5 log -0.5 log Median* N copies/ml = 116 N total = 125 N IU/ml = 9

6 Grunert, SoGAT, Paris, 2004 6 Nov 2002 HBV sample 11037 Median: 858,500 copies/ml*; 118,000 IU/ml 58% +0.5 log -0.5 log Median 83% +0.5 log -0.5 log Median* N copies/ml = 82 N total = 94 N IU/ml = 12

7 Grunert, SoGAT, Paris, 2004 7 Quantitative PCR/NAT Confidence Interval: Median +/- 0.5 log * without results for bDNA for samples <200,000 copies/ml (Nov. 1999 - Nov. 2000) & without results for bDNA for samples <3,000 copies/ml (Apr. 2004) without results for bDNA for samples <1,200 IU/ml (Apr. 2004) # without results for bDNA and hybridization for samples <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) VirusDateNo. of samples Median (copies/ml) (IU/ml) Number of analyses Results in interval: median +/-0.5 log HIV-1Nov 99-Apr 04 Nov 02-Apr 04 32 13 700-21,700 380-14,000 3192 87 92% (88%-98%) 84% (57%-100%) HCV*,& Nov 99-Apr 04 Apr 00-Apr 04 29 26 3,000-1,351,000 1,200-400,000 1050 2319 80%*,& (67%-86%) 93% & (85%-100%) HBV #,$,§ Nov 99-Apr 04 Nov 01-Apr 04 24 18 13,200-1,668,000 1,350-933,000 2186 275 79% #,$ (67%-91%) 73% § (55%-92%)

8 Grunert, SoGAT, Paris, 2004 8 National External Quality Assessment Schemes (EQASs) for BSE Testing Cooperations: K.-O. HabermehlInst. f. Biotechnologische Diagnostik, Berlin H. ZeichhardtCharité Universitätsmedizin Berlin H.-P. GrunertCampus Benjamin Franklin Institut für Infektionsmedizin, Abt. Virologie M. H. GroschupBundesforschungsanstalt f. Viruskrankheiten A. Stolzeder Tiere, Insel Riems Financial support by:BMBF, BMGes, DVV Performed:since May 2002 Participants:Total 56 National Laboratories28 Private Laboratories28 Samples total: > 700

9 Grunert, SoGAT, Paris, 2004 9 National BSE EQASs: Problems of Sample Preparation PrPsc-Concentration in the brain Homogenisation of the brain material Dilution of BSE-pos. brain material in BSE-neg. brain material Matrix problems Lyophilisation and Storage

10 Grunert, SoGAT, Paris, 2004 10 National BSE EQASs: Summary of the Results Date SampleCorrect Results No.Properties% No. of analyses May 2002 1neg.10057/57 2neg.98,256/57 3pos. (1:12)89,551/57 4pos. (1:6)96,454/56 5pos. (1:4)96,555/57 Jun. 2003 1neg.92,738/41 2neg.92,738/41 3pos. (1:12)10041/41 4pos. (1:8)10041/41 5pos. (1:6)10041/41 Mar. 2004 1neg.10044/44 2neg.10044/44 3pos. (1:16)95,542/44 4pos. (1:12)10044/44 5pos. (1:12)10044/44 6pos. (1:6)10044/44

11 Grunert, SoGAT, Paris, 2004 11 2 nd National BSE EQAS June 2003 Variance Analysis of the BioRad Test Results

12 Grunert, SoGAT, Paris, 2004 12 Reference Laboratories Prof. Braun / Prof. Enders, Stuttgart Prof. Doerr / Dr. Berger, Frankfurt Prof. Fleckenstein / Dr.Huber, Erlangen Prof. Gerlich / Dr. Willems, Gießen PD Dr. Groschup, BFAV, Insel Riems Prof. Gürtler, Greifswald Dr. Heckler, Hannover Dr. Heim, Hannover Prof. Krüger / Dr. Meisel, Berlin Prof. Kurth / Prof. Pauli / Prof. Schreier / Dr. Schweiger / Dr. Tischer, RKI, Berlin Prof. Löwer / Dr. Chudy / Dr. Nick / Dr. Nübling / Dr. Scheiblauer / Dr. Unger, PEI, Langen Prof. Müller-Lantzsch / Dr. Gärtner, Homburg/Saar Prof. Neumann-Haefelin, Freiburg Prof. Pfister / Prof. Eggers / Dr. Wieland, Köln Prof. Radsak, Marburg Prof. Roggendorf / Dr. Fiedler, Essen Prof. Siegl, St. Gallen, Switzerland Dr. Vornwald, Berlin Prof. Wutzler / Prof. Faber, Jena