Interim recommendations for deferral of donors at increased risk for HIV-1 Group O infection; guidance document; availability--FDA. Notice.

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Interim recommendations for deferral of donors at increased risk for HIV-1 Group O infection; guidance document; availability--FDA. Notice.

Fed Regist. 1997 Sep 23;62(184):49695. Unique Identifier : AIDSLINE AHA/98055401

Abstract: 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.

Keywords: Blood Banks/*STANDARDS Blood Donors Blood Groups Blood-Borne Pathogens *Guidelines Human HIV Infections/*PREVENTION & CONTROL/TRANSMISSION HIV-1 Risk Factors United States United States Food and Drug Administration JOURNAL ARTICLE
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M9820775

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