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

EQASs for Blood Borne Virus Genomes and BSE Prions from Cattle Brain and INSTAND Reference Materials. H.-P. Grunert 1,2 , K.-O. Habermehl 1,2 , V. Lindig 1 and H. Zeichhardt 1,3

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

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  1. EQASs for Blood Borne Virus Genomesand BSE Prions from Cattle Brainand INSTAND Reference Materials H.-P. Grunert1,2, K.-O. Habermehl1,2 , V. Lindig1 and H. Zeichhardt1,3 1Charité University Medicine Berlin, Campus Benjamin Franklin, Institute for Infectious Diseases Medicine, Dept. Virology, Berlin 2Institute for Biotechnological Diagnostics (GBD), Berlin 3Institute for Standardization and Documentation in Medical Laboratory (INSTAND), Düsseldorf (WHO Collaborating Center) Collaborating Centers of International Consortium for Blood Safety (ICBS), New York

  2. National and WHO International EQASsin Immunology/Virology Samples total: > 549.000 Grunert, SoGAT, Bethesda, 2005

  3. EQASs in Virology Grunert, SoGAT, Bethesda, 2005

  4. Experiences from EQAS for HIV, HCV and HBV:Evaluation of quantitative PCR/NATby median +/- 0.5 log10IU/ml versus copies/ml Grunert, SoGAT, Bethesda, 2005

  5. EQAS Nov 2004 HIV sample 10054median: 1,110 copies/ml; 1,033 IU/ml NAT all [copies/ml] NAT all [IU/ml] Grunert, SoGAT, Bethesda, 2005

  6. 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 <1,220 IU/ml (Apr. 2004) Grunert, SoGAT, Bethesda, 2005

  7. EQAS Nov 2004 HCV sample 12054median: 28,838 copies/ml; 10,200 IU/ml Ntotal = 137 Ncopies/ml = 22 NIU/ml = 115 PCR all [IU/ml] bDNA [IU/ml] PCR all [copies/ml] bDNA all [copies/ml] Grunert, SoGAT, Bethesda, 2005

  8. EQAS Nov 2004 HCV sample 12053median: 3,472 copies/ml; 1,217 IU/ml Ntotal = 136 Ncopies/ml = 22 NIU/ml = 114 PCR all [IU/ml] bDNA [IU/ml] PCR all [copies/ml] bDNA all [copies/ml] Grunert, SoGAT, Bethesda, 2005

  9. 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 <1,220 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, Bethesda, 2005

  10. EQAS Nov 2004 HBV sample 11055median: 1,500,000 copies/ml; 439,000 IU/ml PCR (Roche Copies); N=29 PCR (Abbott Copies); N=1 PCR (in house Copies); N=3 nested PCR (in house Copies); N=1 Taqman (Roche Copies); N=3 Taqman (in house Copies); N=13 Lightcycler (Artus Copies); N=5 Lightcycler (in house Copies); N=10 bDNA (Bayer Copies); N=5 PCR (Roche IU); N=3 PCR (Artus IU); N=1 PCR (in house IU); N=1 Taqman (Artus IU); N=1 Taqman (Roche IU); N=17 Taqman (in house IU); N=4 Lightcycler (Artus IU); N=12 Lightcycler (in house IU); N=2 other PCR (Artus IU); N=2 bDNA (Bayer IU); N=5 Grunert, SoGAT, Bethesda, 2005

  11. National External Quality Assessment Schemes (EQASs) for BSE Testing Grunert, SoGAT, Bethesda, 2005

  12. National BSE EQASs: Summary of the Results Grunert, SoGAT, Bethesda, 2005

  13. 2nd National BSE EQAS June 2003Variance Analysis of the BioRad Test Results Grunert, SoGAT, Bethesda, 2005

  14. Global Network for External and Internal Quality Control Grunert, SoGAT, Bethesda, 2005

  15. National Reference Materials Grunert, SoGAT, Bethesda, 2005

  16. INSTAND Reference Materials(www.instand-ev.de) INSTAND INSTITUTE FOR STANDARDIZATION AND DOCUMENTATION IN MEDICAL LABORATORIES e.V. P.O. Box 250211, D-40093 Düsseldorf, Germany Tel.: +49-211-159213 0, Fax: +49-211-159213 30, E-mail: instand@instand-ev.de Samples for Test Assessment of Virus Diagnostics National Reference Samples (National Working References) Surplus Samples of External Quality Assessment Schemes in Virus Immunology and Virus PCR/NAT As of February 2005 Grunert, SoGAT, Bethesda, 2005

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