Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for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 Products (HCT/Ps); Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft 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 and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated April 2008. This draft guidance is intended for establishments that collect Whole Blood and blood components intended for transfusion and establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The document provides recommendations for testing of donations of Whole Blood and blood components and HCT/P donor specimens 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 recommend use of a licensed NAT to screen donors of Whole Blood and blood components intended for transfusion and for testing donors of HCT/Ps for infection with WNV. FDA recommends the use of licensed NAT testing for WNV within 6 mo