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FDA Authorizes First Molecular At-Home, COVID-19 Test

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eMediNexus    09 March 2021

The US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for the first molecular COVID-19 test for home and over the counter use - the Cue COVID-19 Test. 

This will be the first molecular test that will be available without a prescription. The test can detect genetic material from the SARS-CoV-2 virus in the nostrils and the results of the test are obtained in about 20 minutes one the users smart device through the Cue Health app. The test was found to correctly detect 96% of positive nasal swab samples from people who had symptoms and detected 100% of positive swab samples from those who did not have symptoms. The test can be used in individuals aged 2 years and above, with and without symptoms… (Medscape)

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