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FDA Recommends Screening Blood Donors Nationwide for Babesia

May 22, 2015

tx_news_22_mayBabesia microti, a tick-borne parasite similar to malaria, is responsible for the highest percentage of transfusion-related infectious fatalities in the United States. Although many children and adults with infections are asymptomatic, the disease may be especially fatal in neonates, the elderly, and immune-compromised individuals.

Babesia cases have been observed year-round and have been steadily increasing over the past several years in the United States, especially in the Northeast. The FDA’s Blood Products Advisory Committee (BPAC) recently met to discuss babesia screening for blood donations. The BPAC recommends nationwide year-round antibody screening for babesia in addition to nucleic acid testing in the top 5 endemic states. Following these recommendations would reduce the risk of transfusion-transmitted babesia in the United States by 95%.

Reference
1. FDA Issue Summary. Blood Products Advisory Committee Meeting on Strategies for Implementation of Antibody and Nucleic Acid-based testing for Babesia microti in Blood Donors, May 13, 2015. Accessed online May 19, 2015. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/ bloodvaccinesandotherbiologics/ bloodproductsadvisorycommittee/ucm446274.pdf

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