The U.S. Food and Drug Administration (FDA) has issued an Eemergency Use Authorization (EUA) for the first over-the-counter, non-prescription, fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.
The FDA, in its authorization letter to Ellume, says the test is intended primarily for use in people who have no COVID-19 symptoms or reason to suspect an active infection. The test uses what the FDA calls a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) to detect certain proteins of the virus known as antigens.
One of the caveats is that other antigen tests, there may be a small percentage of both false negatives and false positives. And to use the test, one must down the Ellume COVID-19 Home Test App for iOS or Android phones, which will provide video instruction on the proper use of the test. It takes around 20 minutes to complete the test. The results go to the smartphone app, and are also communicated to local health authorities, according to the FDA EUA.
According to the manufacturer, the test has proved effective 96% of the time. Ellume says more than 3 million tests will be available in January, 2021, and will likely cost around $30.
For more, go to the Ellume web site.
