The FDA says it authorized more than 300 COVID-19 test and collection kits in 2020.
COVID-19 first made waves at the end of 2019 but began to spread throughout the U.S. in the early months of 2020. As the country faced a pandemic, a number of companies developed diagnostics in an effort to slow the spread, with the FDA beginning to issue emergency use authorization (EUA) for the tests in March.
The more than 300 tests and collection kits included 235 molecular diagnostics, 63 antibody tests and 11 antigen tests as of Dec. 28, 2020.
Included in the range of tests are 38 at-home collection kits with samples sent to labs, 18 pooling (processing samples from multiple people at once) tests, 17 point-of-care/rapid tests, 11 multi-analyte (detecting SARS-CoV-2 and other viruses like the flu) and three at-home tests with a self-collected sample.
“Our Center for Devices and Radiological Health (CDRH) has made enormous contributions to the COVID-19 response,” FDA Commissioner Stephen Hahn said in a news release. “To date, the FDA has authorized 309 tests and sample collection devices. This includes a wide variety of tests, including 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests, with tests that can be used in laboratories, in doctors’ offices and other point-of-care settings, and at home.”
However, the advances in testing for the virus over the past 12 months has not come without hitches.
Following the rollout of tests, a number of misleading results, including both false-positives and false-negatives, appeared across the country, leading to FDA warnings and even the revoking of emergency use authorization in some cases.
Still, developments are being made in the testing space, namely in terms of speed for result turnaround and convenience. Last month, the FDA granted EUA for the Ellume COVID-19 Home — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales.
