Covid-19 testing comes home

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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
Date* Company Test Attributes
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
Antigen tests
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. 

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