12/13 March 2024
As an additional part of their ongoing guideline development for the safety of blood and blood products, the FDA published a "Draft Guidance for Industry Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)". A possible requalification of deferred donors is an important topic, especially if reported data (e.g. Stramer SL, Notari EP 4th, Zou S, Krysztof DE, Brodsky JP, Tegtmeier GE, Dodd RY. Human T-lymphotropic virus antibody screening of blood donors: rates of false-positive results and evaluation of a potential donor reentry algorithm. Transfusion 2011;51(4):692-) show an important rate of false positive testing of over 70 000 donors.
Therefore, the FDA published this draft guidance document with the aim to support "blood establishments that collect Whole Blood and blood components, with recommendations for a requalification method under 21 CFR 610.41(b) for deferred donors, based on a determination that their previous reactive test results for antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II) were falsely positive."
In this document, the FDA clarifies the premises for an ongoing deferral as well as for a possible and acceptable requalification method or process, within the meaning of 21 CFR 610.41(b), for reentry of donors deferred because of reactive screening test results for anti-HTLV-I/II under 21 CFR 610.41(a)(1).
Subsequently, the document describes the recommended actions for donor re-entry as well as for the implementation and reporting for such a procedure. For more details, please read the guidance Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II).