(RxWiki News) The US Food and Drug Administration (FDA) has approved two new tests to screen for a tickborne parasite in human blood and plasma donations.
These new tests look for markers of Babesia microti (B. microti) in blood and plasma donations. They are meant to help keep the blood supply safe for blood donation recipients.
“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 Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in a press release. "While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors.”
Most people who develop babesiosis after exposure to B. microti through a tick bite show no symptoms, but some develop symptoms similar to the flu. However, the infection can severely harm those with weak immune systems, the FDA noted.
The FDA reported that the investigational use of blood sample B. microti testing has been underway since 2012. It has resulted in the removal of many infected donations from the blood supply, according to the FDA.
The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is meant to detect infection in plasma samples. And the FDA approved the Imugen Babesia microti Nucleic Acid Test (NAT) to search for infection in blood samples. It is important to note these newly approved tests do not diagnose babesiosis infections.
The FDA approved these tests for Oxford Immunotec, Inc. They are to be used at a facility in Massachusetts.