HIV — the human immunodeficiency virus — is the virus that can lead to acquired immune deficiency syndrome, or AIDS. 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 through use of the donor history questionnaire 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.
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.
FDA's April 2017 Blood Products Advisory Committee (BPAC) heard a summary of comments submitted to the docket on donor deferral policies to reduce the risk of transfusion transmitted HIV. AABB presented a statement expressing support for FDA's re-evaluation of donor deferral policies for individual risk assessment. The association also expressed continuing commitment to the health and safety of volunteer donors and recipients of life saving blood products. A Summary of the BPAC Meeting is posted.
AABB, America’s Blood Centers and the American Red Cross provided joint comments in response to FDA’s July 2016 request regarding its Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
The FDA published a Federal Register Notice to establish a public docket to receive comments on the FDA’s recommendations for reducing the risk HIV transmission by blood donation as described in the December 2015 guidance document "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products."
AABB posted an analysis of the guidance for industry titled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.”
The FDA released a final guidance with new recommendations for a time-based approach to replace the previous approach to evaluate donor eligibility, deferral, requalification, and inventory management for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. Among other changes, the evaluation period of “Since 1977…” has been replaced with a time period that more appropriately reflects current risks and the ability to effectively assess and manage those risks.
April 20, 2021
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