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FDA approves blood screening assay


 

Bags and vials of blood

Photo by Daniel Gay

The US Food and Drug Administration has approved the blood screening assay cobas® MPX for use on the cobas® 6800 and 8800 Systems.

cobas® MPX is a nucleic acid test designed to screen donated blood and plasma for human immunodeficiency virus (HIV),hepatitis B virus (HBV), and hepatitis C virus (HCV).

The test can detect 5 viral targets—HIV-1 Group M, HIV-1 Group O, HIV-2, HBV, and HCV—in a single sample.

cobas® MPX features a dual-target approach with amplification of separate regions of HIV-1 and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.

cobas® MPX is a product of Roche Molecular Diagnostics and can be used on Roche’s cobas® 6800 System or cobas® 8800 System.

These systems are used for routine molecular testing in the areas of donor screening, viral load monitoring, women’s health, and microbiology.

Both systems make it possible for labs to perform up to 3 tests in the same run with no pre-sorting required.

In an 8-hour shift, the cobas® 6800 System can provide 384 results, and the cobas® 8800 System can provide 960 results.

The cobas® 6800 system enables up to 8 hours of walk-away time with minimal user interaction, and the cobas® 8800 enables up to 4 hours of walk-away time.

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