Roche’s first whole blood test for donor screening FDA approved
Roche announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. This is Roche’s first commercially available whole blood test to screen donations and follows May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.1
cobas Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test is able to detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.
In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite can also be transmitted through blood transfusions or from mother to foetus during pregnancy. The parasite infects and destroys red blood cells which can lead to anaemia and related life-threatening complications, particularly in the elderly or otherwise immunocompromised patients. In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.
The Roche Blood Safety Solutions offering now provides the most comprehensive testing solution for blood donor screening utilising the fully automated cobas 6800/8800 System. This novel test approval follows the successful launch of the cobas Zika test, which was the first Zika test available for donor screening in the U.S. This new Babesia test expands the menu of tests available for the cobas 6800/8800 Systems for use in U.S. donor screening laboratories. This menu includes cobas MPX, cobas WNV and cobas Zika. In addition, the menu includes cobas DPX2, which is used in testing labs that support plasma fractionators.
