The Imugen Babesia microti Arrayed Fluorescent Immunoassay detects antibodies of Babesia microti — a parasite transmitted via deer ticks — in blood plasma, while the Imugen Babesia microti Nucleic Acid Test screens for the parasite’s DNA in whole blood samples.
The approval makes both tests the first approved to detect B. microti in donated blood.
“The U.S. blood supply remains the safest in the world thanks in part to the FDA’s ongoing work to enforce standards for blood collection and to identify and respond to potential threats to the nation’s blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors.”
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