December 16, 2020 -- The US Food and Drug Administration on Tuesday granted emergency use authorization for the first non-prescription COVID-19 test that can provide results directly to the consumer within minutes.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D., said in a statement.

The kit manufactured by Ellume uses a sterile nasal swab, a processing fluid, and a testing strip. The testing materials connect to a smartphone that can provide results via Bluetooth in 15 minutes or less, the company said in a news release. The results can be shared with healthcare professionals.

Ellume said the kit will cost around $30 and will be available online or at drug stores, according to the Associated Press.

Last week, the FDA authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit, which can also be purchased online or over-the-counter at a store with a doctor’s prescription. The purchaser of that kit must send the nasal swabs to the company for analysis. Other at-home tests have only been available by prescription.

“Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage,” said Ellume founder and CEO, Sean Parsons MBBS, said in a news release.

The FDA said the Ellume test “correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.”

The agency noted that all tests can provide false negative and false positive results. People who test negative and then show symptoms should follow up with a health care provider.

Show Sources

FDA. "Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19"


AP. “Over-the-counter home test for COVID-19 gets US green light”

WebMD. “FDA Authorizes Nonprescription at-Home COVID Test”

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