The US Food and Drug Administration (FDA) on Tuesday granted an emergency use authorization for the first over-the-counter, at-home test for COVID-19.
According to a news release by the regulatory body, 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.” According to the FDA, the test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample taken from anyone who is 2 years of age or older.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. 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 Stephen M. Hahn said in the release.
“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,” he added.
Similar to other antigen tests, a small percentage of positive and negative results from the test may be false, according to the FDA. False positives can be common when antigen tests are administered in populations where there is a low prevalence of COVID-19 infection.
According to Ellume, the company that developed the test, the test equipment includes a nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer. Once the sample is analyzed, the results are automatically sent to the user’s smartphone via Bluetooth.
“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 email address, and reports the results as appropriate to public health authorities to monitor disease prevalence,” the FDA explains in its release.
The company is expected to produce more than 3 million tests in January 2021.
The state-of-the-art COVID-19 test is still the real-time reverse transcription polymerase chain reaction (RT-PCR) test, which detects the genetic material of the coronavirus, according to the FDA and US Centers for Disease Control and Prevention.