FDA grants EUA to over-the-counter molecular test for COVID-19

The FDA on Tuesday announced it had “issued an emergency use authorization (EUA) for the first over-the-counter molecular test authorized for use with saliva specimens” to Aptitude Medical System Inc.’s Metrix COVID-19 test.

The U.S. Food and Drug Administration (FDA) said the Metrix COVID-19 test was authorized “for non-prescription home use with anterior nasal (nares) swab and saliva sample” by people “without symptoms or other epidemiological reason to suspect COVID-19.”

Per the FDA’s letter of authorization, the Metrix COVID-19 test uses “nucleic acid amplification technology, similar to PCR” to detect SARS-CoV-2, whose “viral RNA is generally detectable in anterior nasal (nares) swab and saliva samples during the acute phase of infection.”

According to the Metrix COVID-19 test’s instructions for home testing, provided by the FDA, a negative test result indicates that SARS-CoV-2 was not detected in the sample, however, “it is possible for this test to give a negative result that is not correct (false negative) in some people with COVID-19.”

FDA’s letter of authorization emphasizes that “negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19,” and, if appropriate, should be confirmed with additional testing.

Positive test results, however, indicate the virus that causes COVID-19 was detected in the sample, but “do not rule out bacterial infection or co-infection with other viruses,” FDA said.

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