Roche’s blood screening assay for three viral target detection receives FDA approval

11 January 2015 (Last Updated January 11th, 2015 18:30)

US Food and Drug Administration (FDA) has approved Switzerland-based Roche's cobas TaqScreen MPX Test, v2.0, designed to simultaneously detect and identify HIV, HCV, and HBV in donations of human whole blood and components.

US Food and Drug Administration (FDA) has approved Switzerland-based Roche's cobas TaqScreen MPX Test, v2.0, designed to simultaneously detect and identify HIV, HCV, and HBV in donations of human whole blood and components.

It can also detect and identify source plasma.

The cobas TaqScreen MPX Test is a qualitative in-vitro test, designed 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.

The TaqScreen MPX Test is claimed to be the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay using multi-dye polymerase chain reaction (PCR) technology.

"The TaqScreen MPX Test is claimed to be the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay using multi-dye polymerase chain reaction (PCR) technology."

Roche Diagnostics chief operating officer 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 centres. This latest approval supports that commitment."

The test was 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 to 96 samples.

It works on the fully automated cobas s 201 system, which allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets and a full-process internal control.

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.

In addition, the cobas TaqScreen MPX Test, v2.0, along with CE Mark, also obtained approvals in Canada, Brazil, China and India.