FDA sanctions AFIA for detecting antibodies to Babesia microti and Imugen Babesia microti NAT

On Mar 7, 2018

The U.S Food and Drug Administration has sanctioned 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.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said “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. While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors.”

Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. B. microti is the main species that causes infection in the United States. There are about 1,000 to 2,000 cases of babesiosis reported in the U.S. each year, with the majority reported from states in the Northeast and upper Midwest. Babesia can also be transmitted by transfusion of blood or blood components collected from an infected donor.

Inflicted patients do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache and body aches. The U.S. Centers for Disease Control and Prevention (CDC) warns that for certain people, especially those with a weak immune system, it can be a severe, life-threatening disease and that while bloodborne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the U.S. and remains an important concern.