REGULATORY UPDATE: AABB, ABC and ARC Ask FDA to Reconsider HTLV-I/II Testing Recommendations
April 09, 2025
The blood community sent a
joint letter this week to FDA’s Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review, with a request for an evidence-based reconsideration of the current testing recommendations for human T-lymphotropic virus types I and II (HTLV-I/II). AABB’s Transfusion Transmitted Diseases (TTD) Committee developed the letter, which was approved by the AABB Board of Directors, America’s Blood Centers, and the American Red Cross.
The letter requests that FDA consider updating the testing requirement to one-time donor testing for antibodies to HTLV-I/II coupled with effective leukoreduction in donations of whole blood and blood components intended for transfusion.
Consistent with CBER’s ongoing evidence-based updates, the blood community believes the HTLV-I/II antibody testing requirement at each donation of whole blood and blood component intended for transfusion should be revised based on the following:
- The declining prevalence of HTLV-I/II infection in US blood donors.
- The low incidence observed among U.S. repeat blood donors.
- The low likelihood of infection and disease in individuals receiving HTLV-I/II antibody-reactive whole blood and blood components.
- The efficacy of leukoreduction in reducing the infectivity of HTLV-I/II antibody-reactive donations.
- The use of effective pathogen-reduction technology for some platelets.
