Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples from Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1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

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The purpose of this guidance document is to inform all establishments engaged in the manufacture of Source Plasma that FDA, has approved nucleic acid tests (NAT) to identify human immundeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in Source Plasma donations; 2) that it believes that a licensed nucleic acid test to identify HIV and HCV in Source Plasma donations, when available, should be used to adequately and appropriately reduce the risk of transmission of these communicable diseases; and 3) that it expects that a licensed nucleic acid test to identify HIV-1 and HCV in Source Plasma donations will be available after establishments submit biological license application (BLA) supplements providing for the use of an approved nucleic acid test, and after we have approved such supplements.