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FDA authorizes first at-home COVID-19 diagnostic test

December 17, 2020 4541

The U.S. Food and Drug Administration on Dec. 15 issued an emergency use authorization for the first over-the counter at-home diagnostic test for COVID-19.

The Ellume COVID-19 Home Test is the first test for COVID-19, the disease caused by the novel coronavirus, that can be used completely at home without a prescription. It uses a nasal swab to detect antigens and is authorized for anyone two years of age or older, including people who are not experiencing symptoms.

The test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, according to the FDA. In people with without symptoms, it correctly identified 91% of positive samples and 96% of negative samples.

The test uses an app to help users administer it and interpret their results, which are delivered in as little as 20 minutes to the user’s smartphone and to their local public health department.

Ellume expects to produce more than three million tests in January 2021.

At-home COVID-19 test not currently recommended for use in the dental office

Due to availability and pricing, CDA does not currently recommend or endorse the Ellume COVID-19 Home Test, nor does it recommend that dentists require patients to take it prior to receiving dental care; however, if a patient is able to obtain a test and provide timely results to the dentist prior to treatment, the practice can use that information in conjunction with other routine COVID-19 pre-appointment screening to determine if the patient is healthy enough to undergo dental care.

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