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Maxim Biomedical OTC COVID-19 Antigen Test Nabs FDA Emergency Use Authorization

NEW YORK – The US Food and Drug Administration last week issued Emergency Use Authorization for Maxim Biomedical's MaximBio ClearDetect COVID-19 Antigen Home Test for over-the-counter use.

The test, which delivers results in 15 minutes, is for identifying the SARS-CoV-2 nucleocapsid protein antigen and can be used for individuals with COVID-19 symptoms, as well as asymptomatic individuals if the test is done twice over three days, the FDA said.

For patients at least 14 years old, self-collected anterior nasal swab samples should be collected within the first five days of the onset of symptoms. Individuals 2 years of age and older need adults to collect anterior nasal swab samples within five days of symptom onset.

Based in Rockville, Maryland, Maxim Biomedical received funding from the US National Institutes of Health's Rapid Acceleration of Diagnostics initiative in September 2020 to develop its rapid SARS-CoV-2 test.