Based on preliminary data presented at the AABB Annual Meeting Plenary Abstract Session in Houston (October 19-22, 2024), the rates of confirmed cases of HIV and HBV have not changed among potential blood donors after the U.S. FDA guidance implemented individual risk assessment for HIV and other sexually transmitted diseases in 2023. Before 2023, blood donor deferrals for HIV were based on sexual orientation, including men who have sex with men. Under the updated guidance, any potential blood donor who has had anal sex with new or multiple partners within the last three months is deferred for three months without evaluation of orientation. Vitalant (a non-profit blood collection agency that collects 11% of the U.S. blood donations operating in 28 states) compared potential donor sexually transmitted infections and risk behaviors for one year before the guidance implementation in September of 2023 and one year after the guidance. Based on 1,306,936 interviews with 642,507 unique donors, the deferral rate based on individual risk assessments (anal sex with new or multiple partners within the last three months) was 0.05% for females (282/598,759) and 0.06% for males (396/708,177). In multivariable analysis, male sex, younger donors and first-time donors were significant predictors of blood donor deferral. Prevalence of HIV and HBV among potential donors, however, was similar before and after FDA guidance implementation. Further monitoring of this new guidance is needed.
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