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H.-P. Grunert 1,2 , K.-O. Habermehl 1,2 and H. Zeichhardt 1,3

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

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H.-P. Grunert 1,2 , K.-O. Habermehl 1,2 and H. Zeichhardt 1,3

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  1. The Impact of International Standard Materials on Correct Test Results: Experiences from EQASs forHIV, HCV, HBV and BSE H.-P. Grunert1,2, K.-O. Habermehl1,2 and H. Zeichhardt1,3 1Charité University Medicine Berlin, Campus Benjamin Franklin, Institute for Infektious Diseases Medicine, Dept. Virology, Berlin 2Institute for Biotechnological Diagnostics (GBD), Berlin 3Institute for Standardization and Documentation in Medical Laboratory (INSTAND), Düsseldorf Collaborating Centers of International Consortium for Blood Safety (ICBS), New York

  2. Quantitative Genome Detection of HCV, HIV and HBV by PCR/NAT Introduction of new quality criteria: Threshold value: Median +/- 1.0 log10 Intended interval: Median +/- 0.5 log10 Grunert, SoGAT, Paris, 2004

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

  4. 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) without results for bDNA for samples <1,200 IU/ml (Apr. 2004) Grunert, SoGAT, Paris, 2004

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

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

  7. 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) without results for bDNA for samples <1,200 IU/ml (Apr. 2004) # 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) Grunert, SoGAT, Paris, 2004

  8. National External Quality Assessment Schemes (EQASs) for BSE Testing Grunert, SoGAT, Paris, 2004

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

  10. National BSE EQASs: Summary of the Results Grunert, SoGAT, Paris, 2004

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

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