December 16, 2020
An over-the-counter coronavirus test that can be solely administered at home and produces results within 15 to 20 minutes has received an emergency use authorization from the U.S. Food and Drug Administration.
The COVID-19 test, developed by the digital diagnostics company Ellume, is the first of its kind to be authorized by U.S. regulators. Other at-home tests either require a prescription or samples be sent to a lab for processing – or both.
The test is designed to detect fragments of coronavirus proteins through a nasal swab. The antigen diagnostic collects a sample further back from the normal nasal swab, but not as far back as the nasopharyngeal swabs.
A liquid sample is then run along a surface with reactive molecules. The test’s analyzer is connected with a smartphone app, which helps users perform the diagnostic and interpret results. The app requires users to report test results to public health officials.
Ellume's COVID-19 test has been authorized for anyone over two years old regardless of whether they are symptomatic.
The test will be available in pharmacies and online, NBC News reported. It is expected to cost about $30.
The diagnostic has an overall accuracy rate of 96%. It correctly identifies a negative result 97% of the time and accurately records a positive test 95% of the time. Those figures are based on clinical trials involving 198 men and women ages 2 to 82.
The test correctly identified 96% of positive samples and 100% of negative samples in people with COVID-19 symptoms. The diagnostic correctly identified 91% of positive samples and 96% of negative samples in asymptomatic people.
Asymptomatic people who test positive are advised to get another test as soon as possible to confirm COVID-19 due to the possibility of an incorrect result.
"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,” FDA Commissioner Dr. Stephen Hahn said in a statement.
"As we continue to authorize additional tests for home use, we are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes."
Ellume is expected to produce 100,000 diagnostics per day in January, with a goal of manufacturing and delivering 20 million tests within the first six months of 2021.
"As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing," Ellume CEO Dr. Sean Parsons said in a statement. "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."