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FDA Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donations of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of H


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
FDA has licensed nucleic acid tests (NAT) as tests to screen blood donors for HIV-1 ribonucleic acid (RNA), and HCV RNA; and these licensed tests can detect evidence of infection at a significantly earlier stage than is possible under previously approved tests using antibody or antigen detection technology; including the HIV-1 p24 antigen test.

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