As the pandemic ebbs, in the West at least, Covid-19 test makers are manoeuvring to shore up their revenues, prompting some to turn to the home testing market. The shift makes sense as hospitals slowly empty of Covid-19 patients who are best served by high-throughput, high-complexity PCR-based assays. So far the US FDA has authorised six antigen tests for home use as well as three that detect the coronavirus’s nucleic acid – but these use isothermal amplification steps rather than PCR, which can only occur in a laboratory. More importantly, many of these are authorised for purchase without a prescription, with the user paying out of pocket, perhaps to show that they are safe to travel, enter a workplace or attend an event. Pricing, however, could be a hurdle. In the US antigen tests from Abbott and Quidel sell to the individual consumer for $10-15 each – fine once, but these tests are best used repeatedly to enable population-level screening. And these are the cheaper ones: some of the others can cost around $50 each.
|Covid-19 home tests authorised by the US FDA|
|Viral RNA tests|
|Nov 17, 2020||Lucira Health||Lucira Covid-19 all-in-one test kit||Lamp, prescription|
|Apr 9, 2021||Lucira Health||Lucira Check-It Covid-19 test kit||Lamp, OTC|
|Mar 5, 2021||Cue Health||Cue Covid-19 test||Isothermal amplification, OTC|
|Dec 15, 2020||Ellume||Ellume Covid-19 home test||Fluorescence, instrument read, OTC|
|Dec 16, 2020||Abbott||BinaxNow Covid-19 Ag card home test||Visual read, prescription|
|Mar 31, 2021||Abbott||BinaxNow Covid-19 antigen self test||Visual read, OTC, serial screening|
|Mar 31, 2021||Abbott||BinaxNow Covid-19 Ag card 2 home test||Visual read, OTC, telehealth supervised, serial screening|
|Mar 1, 2021||Quidel||QuickVue At-Home Covid-19 test||Visual read, prescription|
|Mar 31, 2021||Quidel||QuickVue At-Home OTC Covid-19 test||Visual read, OTC, serial screening|
|*Date EUA first issued. Lamp=loop-mediated isothermal amplification. All antigen tests are lateral flow. Source: FDA.|
Note: "Other" includes 23 antigen tests, six home sampling kits, three saliva collection devices and three IL-6 tests.