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The Canadian Experience with WNV Testing. Bill Casley, PhD Centre for Biologics Research Biologics and Genetic Therapies Directorate Health Canada. West Nile Virus Regulatory Consultative Workshop. February 18-19, 2004. Seasonal Testing ? Blood supply Stockpiling during “safe” season?
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The Canadian Experience with WNV Testing Bill Casley, PhD Centre for Biologics Research Biologics and Genetic Therapies Directorate Health Canada
West Nile Virus Regulatory Consultative Workshop February 18-19, 2004 • Seasonal Testing ? • Blood supply • Stockpiling during “safe” season? • Geographic restrictions on collection? • Minipool vs Individual Testing? • Cells Tissues and Organs • Validation and approval of NAT tests
Blood Issues • Capacity to undertake single unit testing • 10% of total collections • Regional differences in collection/testing • Rationale must be effectively communicated • Different strategies for Hema Quebec and Canadian Blood Services • Seasonal vs year-round testing • Triggers for single unit testing/suspended collection
CTO Issues • Risks from different transplantable tissues unclear • Research required • Approved tests for CTOs not available • NAT testing for CTOs not uniform across provinces • Role for BGTD in overseeing proficiency scheme
WNV Issues to be Addressed2004 • Review of sensitivity and specificity data of the Roche Diagnostics commercial WNV test • What are the risks to switching to seasonal testing over the winter period 2004-2005? • Should single unit testing be the standard test method in 2005? • Do all living and cadaveric transplant donors need to be tested for WNV?