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; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled "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," dated November 2009. This guidance is intended for establishments that collect Whole Blood and blood components intended for transfusion. The document provides recommendations for testing of donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay. FDA believes that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommends use of a licensed NAT to screen donors of Whole Blood and blood components intended for transfusion. The guidance announced in this notice finalizes the recommendations as to Whole Blood and blood components contained in the draft guidance "Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components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 and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Pro