Overview
HIV — the human immunodeficiency virus — is the virus that can lead to acquired immune deficiency syndrome, or AIDS. According to the Centers for Disease Control and Prevention, approximately 56,000 people in the U.S. contracted HIV in 2006. To reduce the risk of transfusion transmission, potential donors of blood as well as human cells, tissue, and cellular- and tissue-based products in the U.S. are screened for exposure to HIV and tested for infection with HIV-1 and HIV-2. Both AABB standards and Food and Drug Administration regulations require that testing be performed for antibodies to HIV-1 and HIV-2 as well as HIV-1 by nucleic acid testing.
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 several African countries, including Cameroon, Benin, Central African Republic, Chad, Congo, Equatorial Guinea and Kenya. 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
5/1/10
FDA releases a guidance providing recommendations to blood and plasma establishments, manufacturers, and testing laboratories for testing individual or pooled samples from donations of blood and blood components for HIV-1 RNA and HCV RNA.
Archived Actions