FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits

Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a couple have also been cleared for all-in-one use obviating the need for a lab at all. And recently, the FDA crossed a new boundary by clearing an all-in-one testing product that can be sold over the counter (OTC) without a prescription.

The Breakthrough

The breakthrough came on Nov. 17 when the FDA granted EUA to 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 the first and, so far, only such kit cleared for OTC. 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.