The FDA has approved Roche’s first commercial test for screening whole blood donations to detect a parasite transmitted by ticks that lives within red blood cells and can cause potentially fatal infections.
The cobas Babesia test, for use on the company’s automated cobas 6800/8800 systems, follows an FDA guidance updated earlier this year on testing to reduce the risk of transmitting the parasite through blood transfusions. According to Roche, the Babesia parasite cannot be detected in traditional plasma or serum samples.
The in vitro diagnostic test also uses a new whole blood collection tube, which consolidates sample preparation steps within the tube itself and can be run alongside other donor screening tests. It is designed to spot the DNA and RNA of the four most common species of Babesia that are known to cause disease in humans.
The parasite, also called Nuttallia, is most often transmitted to humans through the bite of an infected tick, though it can also be passed through blood transfusions or during pregnancy. The parasite destroys red blood cells, causing anemia and other complications, but babesiosis can also be asymptomatic in healthy people.
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“With the approval of Roche’s first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products,” said Thomas Schinecker, CEO of Roche Diagnostics.
“In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve,” Schinecker said.