FDA approves cobas TaqScreen MPX Test v2.0 test for HIV, HCV and HBV

Roche announced that the FDA has approved the cobas TaqScreen MPX Test v2.0 , for use in the detection and identification of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. This latest version of the cobas TaqScreen MPX Test provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay. The combination of viral target detection and identification steps on a fully automated system offers workflow advantages to blood and plasma testing centers by eliminating the need for consecutive rounds of testing, and facilitating earlier donor counseling in the event of a positive result.

Comment: A triple test from Roche to simultaneously detect HIV, Hepatitis C and Hepatitis B in donated blood and blood products. It is the first test approved by the agency to simultaneously for all three of these blood borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.