Bulletin 23-3

Update to Availability of Bio-Rad’s Genetic Systems™ HIV-1/HIV-2 PLUS O EIA Assay

AATB is issuing this Bulletin to update and clarify information that was provided in Bulletin 23-2, published on May 8, 2023, related to the current critical supply issue for a specific anti-HIV-1 and 2 licensed donor screening assay.
Bio-Rad understands the urgency for our community in the availability of their HIV-1/HIV-2 PLUS O EIA assay kits. The issue has been isolated to a manufacturing quality control problem; this is not a biologics/reagent issue. Bio-Rad is working to resolve the issue as quickly as possible to ensure the supply of their HIV kits will not be interrupted. Testing laboratories have or should implement conservation strategies to protect kit supply until Bio-Rad can resume normal kit shipments. 

AATB continues to advise tissue banks using a contract laboratory for donor testing for relevant communicable disease agents or diseases (RCDADs) to proactively work with their lab provider to minimize any potential disruption in HIV antibody testing. Tissue banks performing donor testing using the Bio-Rad/Genetic Systems assay need to discuss this issue with their Bio-Rad representative. All tissue banks should have a business continuity plan that includes being able to send their samples to an alternate testing lab. 
Per 21 CFR 1271.80 and 1271.85, testing potential HCT/P donors for antibodies to HIV-1 and HIV-2 is required, using an assay that has been FDA-licensed, approved or cleared. 
Soliciting responses to questions included in the donor medical history interview (FDA term)/donor risk assessment interview (AATB term) related to being born, lived in or receipt of a blood transfusion in certain Central or West African countries is only required if the HIV-1/HIV-2 test kit used does not detect group O antibodies. All currently FDA-licensed HCT/P donor screening tests for HIV-1 and HIV-2 detect group O antibodies. Such responses to these questions are not in lieu of testing potential HCT/P donors for anti-HIV-1 and HIV-2.
Pertinent background:
FDA’s August 2007 Eligibility Determination for Donors of HCT/Ps Guidance for Industry, that includes questions of which the responses may deem a donor ineligible regarding being born, lived in or receipt of a blood transfusion in certain Central or West African countries is based on the tests that were available at the time of the Guidance’s publication, which included licensed donor screening tests for HIV that did not detect group O antibodies.
If you have questions, please contact standards@aatb.org.