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New FDA Recommendations for Babesiosis Screening of Blood Donations

May 16, 2019

Babesiosis, caused by a tick-borne intra-erythrocytic parasite, is normally asymptomatic in humans but can cause severe and even deadly flu-like symptoms in high-risk individuals. Babesia can also be transmitted through transfusion of blood products. More than 200 cases of transfusion-transmitted babesiosis have been reported since 1980 with a fatality rate of approximately 20% prompting the U.S. Food and Drug Administration (FDA) to finalize recommendations for screening blood products. In brief, the FDA recommends updating donor history questionnaires nationally to incorporate an assessment of prior babesiosis screening results. They also recommend year-round nucleic acid testing or pathogen reduction for blood collected in Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin and Washington, D.C. Donors with a positive test should be deferred for two years. The FDA also emphasizes that these recommendation may be modified as further screening tests are developed and approved since nationwide Babesia antibody screening would be ideal.

Reference:

FDA Guidance for Industry. Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis, May 2019. Accessed online May 12, 2019.

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