Photo by Elise Amendola
Blood for transfusion
The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.
The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.
These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.
The tests are not intended for use in the diagnosis of babesiosis infections.
The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.
The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.
The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”
About babesiosis
Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.
There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.
Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.
For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.
At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.