FDA approves Roche's cobas babesiosis test for blood donations

2019 08 20 21 21 4802 Roche Aacc 2019 400

Roche's cobas Babesia test for screening whole blood specimens from blood donors is now approved by the U.S. Food and Drug Administration (FDA).

The in vitro screening test is designed for use with the company's 6800/8800 systems. Roche noted that the test is compliant with May 2019 guidance from the FDA regarding screening and testing blood donations for Babesia microti, a tick-borne, microscopic parasite that infects red blood cells.

Four species of Babesia can be detected with the test, and a whole blood collection tube provides for efficient screening by labs, according to the company. Testing can be done in parallel with screening of donor specimens for other infections; other assays available for use with Roche's 6800/8800 systems include those for the Zika virus and West Nile virus.