Interim recommendations for deferral of donors at increased risk for HIV-1 Group O infection; guidance document; availability--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection," dated December 11, 1996. The guidance document, which discusses the appearance in 1996 of two cases of HIV-1 Group O infection in the United States, is intended to provide interim measures to reduce the risk of HIV-1 Group O transmission by blood and blood products pending the licensure of test kits specifically labeled for detection of antibodies to HIV-1 Group O viruses. The guidance document recommends adding three questions to screening questionnaires used to exclude donors at high risk of HIV-1 infection.
D001771:Blood Banks / Q000592:standards*; D001782:Blood Donors; D001789:Blood Group Antigens; D017848:Blood-Borne Pathogens; D017408:Guidelines as Topic; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1; D006801:Humans; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration