The test detects the four different species of Babesia parasites capable of causing disease in humans employing new whole blood collection tube to simplify sample preparation
Image: Roche’s cobas Babesia marks the first commercially available whole blood test for screening donor blood. Photo: Courtesy of Hoffmann-La Roche Ltd.
Roche has secured an approval from the US Food and Drug Administration (FDA) for cobas Babesia test to be conducted using cobas 6800/8800 Systems for individual blood donation testing.
Roche said that the cobas Babesia marks the first commercially available whole blood test for screening donor blood to avoid the risk of transmitting parasite through blood transfusions.
Roche Diagnostics CEO Thomas Schinecker said: “We are dedicated to helping save patients’ lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases.
“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.”
Roche’s cobas Babesia detects parasites that live in red blood cells
The cobas Babesia test carried out using the cobas 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia DNA and RNA in whole blood specimens from individual human blood donors.
The test detects the four different species of Babesia parasites capable of causing disease in humans employing new whole blood collection tube to simplify sample preparation.
Roche said that its fully automated cobas 6800/8800 Systems offer results in less time, with the highest throughput and the longest walk-away time available among automated molecular platforms.
Roche said that its Blood Safety Solutions offers a comprehensive testing solution for blood donor screening utilising the fully automated cobas 6800/8800 System.
The cobas Babesia test marks the latest addition to Roche’s list of donor screening tests, including cobas MPX, cobas DPX, cobas HEV, cobas WNV, cobas CHIKV/DENV and cobas Zika, designed to be conducted using cobas 6800/8800 Systems.
Launched in 2014, cobas 6800 and cobas 8800 Systems have enhanced the routine molecular testing through fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship.