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FDA Clears Roche Diagnostics' CMV Test

NEW YORK (360Dx) – The US Food and Drug Administration recently cleared Roche Diagnostics' immunoassay for use as an aid in diagnosing recent or recent cytomegalovirus infection.

The blood-based test, called the Elecsys CMV IgM, is for use with patients including pregnant women, but has not been evaluated in immunocompromised or immunosuppressed individuals. It is not intended for use in neonatal screening or in point-of-care environments, nor is it intended for use in screening blood and plasma donors, according to an FDA document.

Elecsys CMV IgM runs on Roche's Cobas e 801 immunoassay analyzer, which was recently cleared by the FDA for the in vitro determination of analytes in body fluids.

The agency said that the test is a µ-capture immunoassay that uses streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex, and electrochemiluminescence detection. The total "duration" of the assay is 18 minutes.