Bulletin 23-2

Potential Shortage of HIV-1/HIV-2 Plus O EIA Test Kits and Impact on Donor Screening and/or Testing

The American Association of Tissue Banks (AATB) and several of its accredited tissue banks have been informed that there currently is a critical supply issue for the Bio-Rad Laboratories’ Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic) test kit, marketed under the tradename “Genetic Systems HIV-1/HIV-2 Plus O EIA”. This assay is FDA-licensed as an in vitro diagnostic for the qualitative detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2 in living and cadaveric donors. 

FDA regulations at 21 CFR 1271 require that potential donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) are screened and tested for relevant communicable diseases agents and diseases (RCDADs) including but not limited to HIV-1 and HIV-2. 

FDA’s August 2007 Eligibility Determination for Donors of HCT/Ps Guidance for Industry provides a list, in section IV, E, of conditions and behaviors that increase a donor’s relevant communicable disease risk and states: “…in accordance with § 1271.75(d), you should determine to be ineligible any potential donor who exhibits one or more of the following conditions or behaviors.” A list of enumerated items follows and include:

“27. Persons or their sexual partners who were born or lived in certain countries in Africa (Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria) after 1977…(risk factor for HIV group O).  
28. Persons who have received a blood transfusion or any medical treatment that involved blood in the countries listed in criterion 27, after 1977…(risk factor for HIV group O). 
Note: Establishments utilizing an HIV-1/2 antibody donor screening test that has been licensed by FDA and is specifically labeled in the Intended Use Section of the package insert as sensitive for detection of HIV group O antibodies may delete items 27 and 28 from their screening procedures. If such establishments continue to ask items 27 and 28, the donor eligibility may be based on the results of the donor screening test regardless of the answers to items 27 and 28. Establishments that do not utilize an HIV antibody donor screening test that has been licensed by FDA for detection of HIV group O antibodies should continue to ask these items.” 

Current AATB Standards for Tissue Banking include requirements for accredited tissue banks that match the FDA requirements and can be found in its Appendix II: Criteria for Preventing Transmission of RCDADs Through Transplantation of Human Tissue.

Tissue banks that are responsible for making the donor-eligibility determination and are affected by this critical supply shortage may potentially need to use additional screening questions as described above to ensure they remain in regulatory and accreditation compliance.

AATB advises tissue banks using a contract laboratory for donor testing for RCDADs to be proactive and work with the lab so that any potential disruption in HIV antibody testing is identified timely to allow for the necessary donor screening questions to be asked. Or, if tissue banks are performing their own donor testing for RCDADs and using the Bio-Rad/Genetic Systems assay, to discuss the issue with their vendor, also to allow for required screening questions to be administered if necessary.