Chiron/Gen-Probe Procleix HIV/HCV NAT Test To Cost $10-15 Per Screen
This article was originally published in The Gray Sheet
Executive Summary
FDA is preparing to release a draft guidance on nucleic acid test (NAT) screening of whole blood samples following approval of Chiron and Gen-Probe's Procleix HIV-1/HCV NAT assay on Feb. 28
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NAT blood screening
Licensed blood establishments' reliance solely on technologies other than nucleic acid testing for HIV-1 and HCV, such as antibody and antigen tests, "is no longer appropriate," according to a March 13 FDA 1draft guidance. Entitled "Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV," the guidance follows FDA's Feb. 27 approval of Chiron/Gen-Probe's Procleix HIV-1/HCV NAT test (2"The Gray Sheet" March 4, 2002, p. 17). The guidance recommends blood establishments implement licensed NAT testing within six months of release of the final guidance. The draft also advises blood establishments transitioning to NAT testing to notify the agency in their annual report...