Agency Greenlights First Over-the-Counter, At-Home COVID-19 Testing Kit

Nearly 250 COVID-19 diagnostic tests have gotten Emergency Use Authorization (EUA) from the FDA since the pandemic started. Almost all of them have been prescription products. In addition, 25 test kits have been cleared for home collection of samples. One of these products, Lucira Health’s COVID-19 All-in-One Test Kit which received EUA on Nov. 17, is an all-in-one COVID-19 diagnostic enabling people to test themselves in their own home. But even that product requires a prescription. On Dec. 15, the FDA took things to the next level by greenlighting a full at-home COVID-19 testing kit that can be sold over the counter.

The Ellume COVID-19 Home Test

The OTC product that broke this new ground is the Ellume COVID-19 Home Test, a rapid antigen test capable of detecting fragments of the SARS-CoV-2 virus. Although the assay is performed on samples taken from nasal swabs, it’s a Nasal mid-turbinate (NMT) test, which makes it less invasive than tests performed on samples taken using the much longer Nasopharyngeal (NP) swabs that require a trained a health care provider to administer.

More significantly, it’s an over-the-counter rather than a prescription test. Accordingly, FDA Commissioner Stephen M. Hahn, MD, hailed the approval as “a major milestone” in COVID-19 testing. “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,” Hahn suggests.

Costing about $30, the Ellume test kit includes a sterile nasal swab, dropper, processing fluid, and a Bluetooth-connected “Analyzer,” that pairs with an app providing step-by-step video instructions that users can upload to their smartphone. After the sample is analyzed, results are delivered to the user’s smartphone via Bluetooth in 15 minutes or less.

The test is pretty accurate, having correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms, according to the FDA. The test also correctly identified 91 percent of positive samples and 96 percent of negative samples in asymptomatic persons.

However, because antigen tests are generally prone to both false negative and positive results, the FDA recommends that patients who not displaying COVID-19 symptoms treat positive results as “presumptively positive until confirmed by another test as soon as possible.” This is likely to be particularly relevant for communities with fewer infections, because false positive results can be more common when antigen tests are used in populations where there’s low prevalence of COVID-19.

Here are the other key new FDA EUAs and international clearances announced in December:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: