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This document outlines the critical discussions and findings from the West Nile Virus Regulatory Consultative Workshop held on February 18-19, 2004, led by Dr. Bill Casley at Health Canada. Key topics included seasonal testing strategies for blood supply, stockpiling during safe seasons, geographic restrictions on collection, and the effectiveness of individual versus minipool testing. The workshop emphasized the need for communication regarding different collection and testing strategies for Hema Quebec and Canadian Blood Services, as well as the varying risks associated with transplantable tissues.
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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?