FDA authorizes first over-the-counter test for COVID-19

The U.S. Food and Drug Administration announced on Tuesday the emergency use authorization for the first over-the-counter at-home diagnostic test for the novel coronavirus (COVID-19), according to a statement released by the agency.

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The 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 newly authorized test uses a mid-turbinate nasal swab to detect certain proteins of the virus known as antigens. The Ellume COVID-19 Home Test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms, according to the statement. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

The test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone. The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address, and reports the results as appropriate to public health authorities to monitor disease prevalence. Ellume representatives said the company expects to produce more than three million tests in January 2021.

The announcement follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.

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