Dec. 16 (UPI) -- Federal regulators have given emergency approval for a breakthrough over-the-counter, at-home diagnostic test for COVID-19.
The agency found that the test correctly identified 91% of positive samples and 96% of negative samples in people without COVID-19 symptoms.
Ellume's is the first COVID-19 home test that does not require a laboratory or a prescription. Its FDA approval marks a "major breakthrough for Americans' ever-expanding access to convenient COVID-19 testing options," Health and Human Services Secretary Alex Azar said in a statement.
The nasal swab antigen test was developed with a $30 million grant from the National Institute of Health's RADx program, a component of the Trump administration's Operation Warp Speed initiative to develop a coronavirus vaccine.
"Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Stephen Hahn said.
"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."
The Ellume 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 anyone at least 2 years of age.
In addition to its high accuracy for detecting asymptomatic carriers, trials showed the test also correctly identified 96% of positive samples and 100% of negative samples in those exhibiting symptoms.
The $30 test kit includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer for use with a mobile phone app.
In the app, the user follows video instructions to perform the test, including a self-collected mid-turbinate nasal swab. The sample is analyzed and results are automatically transmitted to the user's smartphone within 20 minutes.
Results can be shared with healthcare professionals or transmitted to local health authorities, employers and educators, the company said.
Ellume said it plans to deliver 20 million tests in the United States during the first half of 2021.
In August, Abbott Laboratories rolled out its BinaxNOW COVID-19 Ag Card, which it says gives test results in 15 minutes, can produce results on a small card and costs $5. That test, though, is recommended to be administered by a physician or health provider.