One to two thousands cases of babesiosis are reported in the United States (U.S.) each year, mainly in the Northeast and upper Midwest. Babesiosis infections are normally asymptomatic, but can cause flu-like symptoms that may become life-threatening, especially in individuals with weakened immune systems. The tick-born pathogen Babesia microti is responsible for the majority of cases, but the hemolytic parasite is also the most common transfusion-transmitted parasitic infection in the U.S. Previously there were no U.S. Food and Drug Administration (FDA) approved assays for babesiosis. Investigational use of arrayed fluorescence immunoassays and real-time PCR for detecting B. microti antibodies in plasma and nucleic acid in whole blood samples, respectively, have removed hundreds of B. microti-infected blood donations since 2012 and have demonstrated the effectiveness of the new screening tools. The FDA just approved these two B. microti screening tests. Guidelines for their use are expected later this year.
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