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Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003 Automated Extraction for.

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Presentation on theme: "Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003 Automated Extraction for."— Presentation transcript:

1 Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003 Automated Extraction for RNA/DNA Combined with TaqMan Technology and Cobas Ampliscreen Elisa Moretti Process and Analytical Development KEDRION S.p.A SoGAT XVI Paul Ehrlich Institut - Langen, Germany 3 rd July 2003

2 NAT Development Single extraction for RNA & DNA HIV-1, HBV & HCV KIT Cobas Ampliscreen (Cobas Amplicor) ROCHE In-house Protocol (ABI PRISM 7900HT) APPLERA PVB19 & HAV Virus Kit (BIOROBOT 9604 QIAGEN) AMPLIFICATION & DETECTION

3 Final Results Instruments validation according to GMPs HAV: Detection Limit: 33,68 UI/ml 95% C.I. 25,86 - 49,86 UI/ml HAV-RNA ISS 0201 Preliminary Results HCV 12 UI/ml = 100 % 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

4 Detection Limit: 133,35 UI/ml 95% C.I. 107,63 - 185,77 Linearity: 10 5 -10 3 UI/ml Cross-contamination: Problems with high PVB19 titre WHO IS 99/800 NIBSC Parvovirus B19 Alternative extraction QIAamp MinElute Virus Spin Kit or Ampliscreen Amplification & Detection ABIPrism 7900HT Evaluation in progress Validation: Quantitative Method (PA/PH/OMCL (03) 38 2R; June 2003)

5 Acknowledgements Laboratory of Immunology ISS Giuliano Gentili German Red Cross, Frankfurt Willi Kurt Roth Kedrion Giampaolo Nardi

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