Transfusion-Transmitted Babesiosis.

Babesiosis is most commonly caused by Babesia microti and is transmitted via the bite of an infected Ixodes spp tick. However, Babesia is also transmitted via blood transfusion. In the United States, the first case of transfusion-transmitted babesiosis was recognized in 1979, and in recent years, the incidence has rapidly increased. Because most of the infected blood donors do not experience any symptoms, they pose a significant risk to the blood supply. Donor deferral for a history of babesiosis is currently performed but is ineffective. In March 2018, the FDA licensed a DNA PCR and antibody assay that were used in tandem in pivotal trials for screening blood donors for B microti; with other assays still being evaluated under investigational new drug protocols. Blood donation screening is essential to reducing the risk of transfusion-transmitted babesiosis, which is why blood centers collecting in geographic regions of highest risk have been testing since approximately 2010. Investigational NAT assays of higher sensitivity are pending FDA review. Further, in July 2018, the FDA issued a draft guidance for reducing the risk of transfusion-transmitted babesiosis. Release of the final guidance may be postponed until sensitivities and specificities of all current and potential strategies have been properly evaluated.