FDA approves test used to screen blood for HIV and HBV, HCV
The FDA approved the latest version of the cobas TaqScreen MPX Test, an in vitro test, to be used for identifying and detecting HIV, hepatitis B and C virus infections in human blood donations and source plasma, according to a news release from the manufacturer.
The cobas TaqScreen MPX Test, v2.0 (Roche) is a blood assay that can be used to simultaneously identify and distinguish between HIV, HBV DNA and HCV RNA in human plasma and will help reduce the sample volume required and the turnaround time for donor testing, according to the release.
“Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale,” Roland Diggelmann, chief operating officer of Roche, said in the release. “By continually developing these innovative products, we are striving for the highest level of safety for patients and efficiency for blood and plasma centers.”
The test is designed to be used for screening donations of human whole blood and blood components in pools of six samples and source plasma donations in pools of up to 96 samples, according to the release.