HIV
Overview
Potential donors of blood as well as human cell, tissue and cellular- and tissue-based products in the U.S. are screened for exposure to HIV, the virus that causes AIDS, and tested for infection with HIV-1 and HIV-2. Both the AABB Standards for Blood Banks and Transfusion Services and Food and Drug Administration regulations require that all units of blood and blood components be nonreactive for anti-HIV-1 and anti-HIV-2 as well as HIV-1 by nucleic acid testing prior to being issued for transfusion.
Some donor screening tests shown to be effective in screening for the presence of HIV-1 and HIV-2 viruses have reported false negative results for a rare subtype of HIV-1 called group O (for “outlier”). This group of viruses is primarily found in African countries adjacent to Cameroon and also has been reported in Europe and the U.S. To screen for HIV-1 group O, blood and HCT/P collection facilities must utilize an HIV test that includes a claim for detection of antibodies to HIV-1 group O viruses and has been approved by the FDA for donor screening. If the licensed test is not used, facilities must include donor screening questions to help identify those who may be at risk for this type of infection.
On behalf of the transfusion medicine and cellular therapies community, AABB works directly with the FDA or through government advisory committees as part of ongoing, collaborative efforts to protect against the transmission of HIV through the blood and HCT/P supply.
Recent Actions:
12/14/07
FDA announces that is has withdrawn a guidance document on the management of donors at increased risk of HIV-1 group O infection that was released Dec. 10 for immediate implementation due to comments the agency has received.
12/10/07
The Food and Drug Administration issues a guidance document outlining recommendations for the management of donors at increased risk for human immunodeficiency virus type 1 group O infection, including a list of high-risk countries that should be included in the donor history questionnaire, recommendations for discontinuing the use of some questions used to identify at risk donors, and recommendations, criteria and an algorithm for re-entry of previously deferred donors.