"Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components (Including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus;" Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components (Including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV," dated October 2004. The guidance provides recommendations to all establishments that manufacture Whole Blood and blood components (including Source Plasma and Source Leukocytes) on the implementation of licensed nucleic acid tests (NAT) to identify human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA), and hepatitis C virus (HCV) RNA in donations of Whole Blood and blood components to reduce the risk of transmission of these agents; and the reporting to FDA of such implementation. The guidance announced in this notice finalizes the draft guidances entitled "Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV," dated December 2001 and "Use of Nucleic Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood