FDA grants EUA for OTC diagnostic COVID-19 test

Dec. 16, 2020

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for an over-the-counter (OTC) test for COVID-19 that can be done completely at home, according to a press release from the agency.

Specifically, the EUA was granted for the Ellume COVID-19 Home Test, which 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.

Last week, the agency granted EUA to allow LabCorp to make the Pixel by LabCorp COVID-19 Test Home Collection Kit available to consumers over the counter without a prescription. With the LabCorp test, patients collect a specimen at home, but the test is conducted in a lab, with results available through a web portal.

The announcement of the first fully at-home OTC COVID-19 diagnostic test 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 said the Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.

The Ellume COVID-19 Home Test uses 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. The Ellume COVID-19 Home Test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

The Ellume COVID-19 Home 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 expects to produce more than three million tests in January 2021.

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