FDA OKs First Tests to Detect Tickborne Parasite in Whole Blood and Plasma

Andy · Mar 9, 2018

The first screening tests for antibodies to Babesia microti in human plasma samples and B microti DNA in human whole blood samples have been approved by the US Food and Drug Administration (FDA).

The Imugen B microti Arrayed Fluorescent Immunoassay (AFIA) detects the antibodies in human plasma samples, and the Imugen B microti Nucleic Acid Test (NAT) detects B microti DNA in human whole blood samples.

Both 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," the FDA noted in a news release.
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https://www.medscape.com/viewarticle/893546

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FDA OKs First Tests to Detect Tickborne Parasite in Whole Blood and Plasma

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FDA OKs First Tests to Detect Tickborne Parasite in Whole Blood and Plasma

Andy Committee Member

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