Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion

摘要

The FDA is issuing this guidance to provide you with recommendations for testing donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay. 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 Nto screen donors of Whole Blood and blood components intended for transfusion for infection with WN The recommendations in section III of this guidance apply to all donations of Whole Blood (as defined in Title 21 Code of Federal Regulations (CFR) 640.1) and blood components for transfusion. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDAs current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDAs guidances means that something is suggested or recommended, but not required.