Switzerland-based Roche has received approval from the US Food and Drug Administration (FDA) for its cobas TaqScreen MPX Test, v2.0 for simultaneous detection and identification of HIV, HCV, and HBV in donations of human whole blood and blood components, including source plasma.
The test is a qualitative in vitro test to detect Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma.
Roche Diagnostics COO Roland Diggelmann said: "Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale.
"By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment."
The test has been developed for use in the screening donations of human whole blood and blood components in pools of six samples and source plasma donations in pools of up to96 samples.
Through using multi-dye PCR technology, the test simultaneously detects and separates individual specimens for HIV, HCV and HBV.
The test works on the fully automated cobas s 201 system that allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets and a full-process internal control.
The menu of the cobas s 201 system includes tests for West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV), in addition to HIV, HCV and HBV.
The cobas TaqScreen MPX Test, v2.0, along with CE mark, has also obtained approvals in Canada, Brazil, China and India.
Image: The administration and R&D buildings, Roche Diagnostics Ltd, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.