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.

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