Automated Extraction for RNA/DNA Combined with Taq. Man Technology and Cobas Ampliscreen Elisa Moretti Process and Analytical Development KEDRION S. p. A So. GAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003
NAT Development Single extraction for RNA & DNA Virus Kit (BIOROBOT 9604 QIAGEN) AMPLIFICATION & DETECTION HIV-1, HBV & HCV KIT Cobas. Ampliscreen (Cobas Amplicor) ROCHE PVB 19 & HAV In-house Protocol (ABI PRISM 7900 HT) APPLERA
Final Results Preliminary Results • Instruments validation according to GMPs • HCV 12 UI/ml = 100 % • HAV: Detection Limit: 33, 68 UI/ml 95% C. I. 25, 86 - 49, 86 UI/ml HAV-RNA ISS 0201 WHO IS 96/790 NIBSC • HIV-1 100 UI/ml = 100% WHO IS 97/656 NIBSC • HBV 6 UI/ml = 100 % WHO IS 97/746 NIBSC
Parvovirus B 19 • Detection Limit: 133, 35 UI/ml 95% C. I. 107, 63 - 185, 77 • Linearity: 105 -103 UI/ml • Cross-contamination: Problems with high PVB 19 titre WHO IS 9 800 NIBSC 9/ • Alternative extraction QIAamp Min. Elute Virus Spin Kit or Ampliscreen • Amplification & Detection ABIPrism 7900 HT Evaluation in progress • Validation: Quantitative Method (PA/PH/OMCL (03) 38 2 R; June 2003)
Acknowledgements • Laboratory of Immunology ISS Giuliano Gentili • German Red Cross, Frankfurt Willi Kurt Roth • Kedrion Giampaolo Nardi
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