Agency Authorizes First OTC All-in-One At-Home COVID-19 Testing Kit

Since the pandemic began, the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for more than 225 COVID-19 diagnostic tests. Among these, 25 have been cleared for home collection of samples. On Nov. 17, the agency broke new ground by clearing Lucira Health’s COVID-19 All-in-One Test Kit, the first all-in-one COVID-19 diagnostic enabling people to test themselves in their own home to receive EUA. On Dec. 15, the agency went one step further by issuing EUA for a full at-home testing kit for the virus that does not require a prescription. The Ellume COVID-19 Home Test The distinction of being the first went to the Ellume COVID-19 Home Test, is 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 is 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 is 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. […]