FDA Approves First Commercial COVID-19 Home Inspection Kit

The US Food and Drug Administration (FDA), which licenses medicines for sale in the United States, has approved for the first time the marketing of a new coronavirus infection (COVID-19) test kit that is easy to use at home.

Can You Get a Covid Test at Home? --WSJ
https://www.wsj.com/articles/can-you-get-a-covid-test-at-home-11607980810

FDA authorizes rapid, at-home coronavirus test --Axios
https://www.axios.com/fda-authorizes-rapid-at-home-coronavirus-test-85012e02-6c4f-4d98-be7d-8334d85a6c4c.html

During the pandemic of the new coronavirus, many pharmaceutical companies have started developing a new coronavirus test kit that can be used at home.

The 202,012 May 15, to develop and sell medical diagnostic products of digital correspondence Ellume , it has received approval to sell its own COVID-19 home test kit that was developed as America's first commercially available for at-home test kit. Ellume's home-based laboratory kit, which has also received an emergency use authorization from the FDA, shows 96% accuracy in multisite clinical trials. The test method is a nasopharyngeal swab , and it is also characterized by a sense of speed that the test results can be obtained in just 15 minutes. The price is $ 30 (about 3100 yen), and Ellume has already increased the production of home inspection kits, and it seems that it will be possible to inspect more than 100,000 times a day in January 2021.

FDA authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test | Ellume
https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test/

In addition, the FDA has asked Lucira Health , which develops home-based testing kits for COVID-19, to develop mobile apps and websites that enable better data tracking.

In addition, on December 16, 2020, the FDA approved the emergency use of the COVID-19 home test kit 'Binax NOW COVID-19 Ag Card Home Test'. The 'Binax NOW COVID-19 Ag Card Home Test' is a test kit performed by individuals over the age of 15 who are suspected of being infected with COVID-19 within 7 days of the onset of symptoms using a nasopharyngeal swab collected by themselves. Adults are required to collect nasopharyngeal swabs for use by children aged 4-14 years.

Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-authorization-binaxnow-covid-19-ag-card-home-test