FDA Approves the First At-Home COVID-19 Test

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Ready to head to the drug store for a COVID test? The FDA issued an emergency use authorization for the first over-the-counter diagnostic COVID-19 test. 

The rapid test, created by Ellume, uses a nasal swab to detect fragments of protein of the SARS-CoV-2 virus. Its price is said to be $30 or less, and the company plans to have 20 million tests available in the first half of 2021. 

The Ellume COVID-19 Home Test is the first COVID-19 test that does not require a prescription and can be used completely at home. As with other antigen tests, there is the risk of a false positive or negative. The FDA warns a positive result should be treated as a positive result, even if the person is not showing symptoms until another test can be taken. The test shares the results with appropriate public health authorities to help monitor disease prevalence.