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FDA Approves Blood Test for Simultaneous Detection of HIV, Hepatitis Viruses
The FDA has approved the cobas TaqScreen MPX test, v2.0 for use in the detection and identification of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) in donations of human whole blood and blood components, including source plasma.
According to the product’s manufacturer (Roche), 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 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 by facilitating earlier donor counseling in the event of a positive result, Roche says.
By using real-time, multi-dye polymerase chain reaction (PCR) technology, the test simultaneously detects and discriminates individual specimens for HIV, HCV and HBV, reducing the sample volume required and the turn-around time for donor testing.
The cobas TaqScreen MPX test, v2.0 is a qualitative in vitro test for the direct detection of HIV type 1 (HIV-1) group M RNA; of HIV-1 group O RNA; of HIV type 2 (HIV-2) RNA; of HCV RNA; and of HBV DNA in human plasma. The test is intended for use in the screening donations of human whole blood and blood components in pools of six samples, and in source plasma donations in pools of up to 96 samples.
The test runs on the automated cobas s 201 system, which is designed to increase processing efficiency in a new modular design with ready-to-use reagents. The system allows signal detection in four separate channels, facilitating simultaneous monitoring of three viral targets (HIV, HCV, and HBV) plus a full-process internal control.
In addition to HIV, HCV, and HBV, the menu of the cobas s 201 system includes tests for West Nile virus, parvovirus B19 (B19V), and hepatitis A virus (HAV).
Source: Roche; January 9, 2015.