Update: More COVID-19 Self Tests Hit the Market—Including an OTC Version

A pair of new COVID-19 self-test kits received approval from the Food and Drug Administration this week. The biggest—and possibly most concerning—difference between the two is that one is available without a prescription. The first, BinaxNOW from Abbott, was already approved for, and being administered by, healthcare professionals. Now, however, patients who want to be tested can log on to an Abbott app with their smartphone to be connected to a healthcare provider at eMed. After answering a few questions, the provider can e-prescribe the test for the patient to self-administer. eMed ships the test and supervises its administration. Results are delivered through the app the patient logged onto at the outset of the process. The other newly approved product, the Ellume COVID-19 Home Test, is the first fully at-home test for the virus, and the first test available without a prescription. Users perform their own nasal swab, insert the swab into a Bluetooth-enabled analyzer, and transmit to various receivers in their area. The app then informs the user of the results within 20 minutes or so. As we’ve pointed out previously, the concern is that patients as a group will have widely variable ability to follow the instructions in order to get valid results, and that there will be breakdowns in reporting of results (something that’s already a challenge even among healthcare providers).