FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

Press Announcements > FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

New donor screening tests to help reduce risk of transfusion transmitted babesiosis

The U.S. Food and Drug Administration today approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples. These tests are intended to be used as donor screening tests on samples from individual human donors, including volunteer donors of whole blood and blood components, as well as living organ and tissue donors. Continue reading.