Roche has secured US regulatory approval for cobas Babesia, a qualitative in-vitro nucleic acid screening test for individual blood donations.
The US Food and Drug Administration (FDA) approved the whole blood test for use on the company’s cobas 6800 / 8800 Systems.
Babesia is a parasite typically transmitted via tick bite. However, it can also infect through blood transfusions or spread from mother to foetus during pregnancy.
The parasite destroys red blood cells, resulting in anaemia and associated life-threatening complications in elderly people and immunocompromised patients. Infection in healthy individuals can be asymptomatic or exhibit mild flu-like symptoms.
Roche notes that the parasite cannot be identified using standard plasma or serum sample analysis.
The cobas Babesia test was proven to directly detect DNA and RNA of four common species of the Babesia parasite in whole blood specimens obtained from individual human blood donors.
Sample preparation for the test can be completed using Roche’s whole blood collection tube. The test can also be carried out alongside existing tests for routine blood donor screening, added the company.
Roche Diagnostics CEO Thomas Schinecker said: “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.
“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.”
The cobas Babesia test expands the company’s Blood Safety Solutions range, which includes recently launched cobas Zika test for donor screening in the US.
The tests can be performed using the fully automated cobas 6800 / 8800 Systems that are said to offer faster time to results.