1. The Canadian Experience with WNV Testing
Bill Casley, PhD
Centre for Biologics Research
Biologics and Genetic Therapies Directorate
Health Canada

2. 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

3. 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

4. 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

5. WNV Issues to be Addressed 2004
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 ?
Should single unit testing be the standard test method in 2005?
Do all living and cadaveric transplant donors need to be tested for WNV?