About This File
- Docket Number: FDA-2008-D-0263
- Issued by: Center for Biologics Evaluation and Research
We, FDA, are issuing this guidance to provide you1 with recommendations for testing donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay2 . We believe that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommend that you use a licensed to screen donors of Whole Blood and blood components intended for transfusion for infection with WNV.