1 / 5

Automated RNA/DNA Extraction with TaqMan Technology

Process and Develop Analytical Solutions for Efficient RNA and DNA Extraction Combined with TaqMan Technology. Validation according to GMPs. Achieve Detection Limits for HAV, HCV, HBV, HIV-1, and Parvovirus B19.

clakey
Download Presentation

Automated RNA/DNA Extraction with TaqMan Technology

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Automated Extraction for RNA/DNA Combined with TaqMan Technology and Cobas AmpliscreenElisa Moretti Process and Analytical DevelopmentKEDRION S.p.ASoGAT XVIPaul Ehrlich Institut - Langen, Germany3rd July 2003

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

  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. Parvovirus B19 • Detection Limit: • 133,35 UI/ml • 95% C.I. • 107,63 - 185,77 • Linearity: • 105-103 UI/ml • Cross-contamination: • Problems with high • PVB19 titre • WHO IS 99/800 NIBSC • 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

More Related