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Procleix ® WNV Assay: A TMA-based Assay for Screening Blood Donations for West Nile Virus RNA

Procleix ® WNV Assay: A TMA-based Assay for Screening Blood Donations for West Nile Virus RNA. SoGAT July 3, 2003. Jeff Linnen, Ph.D. Research and Development Gen-Probe Incorporated, San Diego, CA USA. Procleix® is a registered trademark of Chiron Corporation. TECAN.

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Procleix ® WNV Assay: A TMA-based Assay for Screening Blood Donations for West Nile Virus RNA

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  1. Procleix® WNV Assay:A TMA-based Assay for Screening Blood Donations for West Nile Virus RNA SoGATJuly 3, 2003 Jeff Linnen, Ph.D. Research and Development Gen-Probe Incorporated, San Diego, CA USA Procleix® is a registered trademark of Chiron Corporation

  2. TECAN Target Capture System (TCS) Luminometer Procleix WNV Assay • Based on Transcription Mediated Amplification (TMA) • Uses same instrument platform as Gen-Probe’s licensed NAT blood screening assay • Procleix Semi-automated System currently used withProcleix HIV-1/HCV Assay

  3. Specificity of the Procleix WNV Assay • 1,680 normal blood donations were tested at Gen-Probe • 99.8% initial specificity; 100% resolved specificity • over 40,000 archived samples from 2002 high risk populations have been tested by American Red Cross (S. Stramer) • No cross reactivity to other blood borne viruses • Testing included HTLV, HIV-1/-2, HCV, HBV, HGV, Rubella, HAV, CMV, EBV, HCV, Parvo B19 • Assay designed to specifically detect West Nile virus: • No cross reactivity to other flaviviruses: Dengue (1-4), Yellow Fever Virus, and St. Louis Encephalitis virus; weak cross reactivity to Murray Valley Encephalitis virus • Detects Kunjin virus (Australian subtype of West Nile virus)

  4. **Quantitation for this panel is probably not accurate Analytical Sensitivity Based on data from Procleix WNV Assay kit lot manufactured at 2 million test scale *virus quantified by BBI TaqMan Assay (BBI Diagnostics, West Bridgewater, MA). Probit Analysis (results from BBI panels): Lineage 1: 95% detection at 4 to 14 copies/mL Lineage 2: 95% detection at 4 to 8 copies/mL

  5. Samples from CDC WNV Transfusion Transmission Case Investigations (2002) • Positive Results from testing 383 blinded samples sent to Gen-Probe from the American Red Cross • All donations implicated in transfusion transmission were detected at 1:16 dilution with TMA

  6. Nationwide WNV Blood Screeningin the United States, 2003 • Testing using the Procleix WNV Assay started on June 19 • Implemented nationwide on July 1 • Test development which normally takes 2 to 3 years was condensed into less than 9 months. • Procleix WNV Assay is being used to test over 80% of the US blood supply • Most donations are being tested in pools of 16 (some sites are testing individual donations) • reactive pools will be resolved to individual donation • Testing will reduce the risk of WNV transfusion transmission • will provide real time surveillance of human WNV activity in North America

  7. Acknowledgements • Gen-Probe WNV Assay Development Team • (Front to back, left to right) Mike Shih, Josh Cary, Geoffrey Dennis, Janice Cline, Martha Alden, Wen Wu, Mackenzie Lewis, Michelle Cass, Amy Broulik, Jeff Linnen, Stephanie Miller • National Heart, Lung, and Blood Institute (NHLBI) for partial funding • Susan Stramer, American Red Cross • Chiron Corporation

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