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

Grunert, SoGAT, Paris, 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

Grunert, SoGAT, Paris, Apr 2003 HCV sample 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

Grunert, SoGAT, Paris, 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) 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 ,000-1,351,000 1, , %*,& (67%-86%) 93% & (85%-100%)

Grunert, SoGAT, Paris, Apr 2003 HIV sample 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

Grunert, SoGAT, Paris, Nov 2002 HBV sample 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

Grunert, SoGAT, Paris, 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) 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 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 HIV-1Nov 99-Apr 04 Nov 02-Apr , , % (88%-98%) 84% (57%-100%) HCV*,& Nov 99-Apr 04 Apr 00-Apr ,000-1,351,000 1, , %*,& (67%-86%) 93% & (85%-100%) HBV #,$,§ Nov 99-Apr 04 Nov 01-Apr ,200-1,668,000 1, , % #,$ (67%-91%) 73% § (55%-92%)

Grunert, SoGAT, Paris, 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

Grunert, SoGAT, Paris, 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

Grunert, SoGAT, Paris, National BSE EQASs: Summary of the Results Date SampleCorrect Results No.Properties% No. of analyses May neg.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 neg.92,738/41 2neg.92,738/41 3pos. (1:12)10041/41 4pos. (1:8)10041/41 5pos. (1:6)10041/41 Mar neg.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

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

Grunert, SoGAT, Paris, 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