Saliva swab test for Dx of congenital CMV gains FDA approval
A new type of diagnostic test to help detect cytomegalovirus infections in newborns within their first 3 weeks of life has received FDA approval.

The Alethia CMV Assay Test System detects CMV DNA from a saliva swab. Results from the test should be used only in conjunction with the results of other diagnostic tests and clinical information, according to an FDA statement.

The recently approved Alethia CMV Assay Test System uses loop-mediated isothermal amplification, which is less complex and costs less than polymerase chain reaction testing, to detect cytomegalovirus DNA from a saliva swab. The assay produces results within an hour; results should be confirmed with additional tests and clinical information. Early antiviral treatment can help prevent hearing loss.

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