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FDA authorizes first fully at-home COVID-19 test kit


CREDIT: LUCIRA HEALTH

The Food and Drug Administration has authorized emergency use of the first at-home coronavirus test, which gives results back in about 30 minutes.


"While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," said the FDA Commissioner Stephen M. Hahn, M.D.


Lucira Health, a California manufacturer, claims that the tests have a sensitivity (how well it detects positive cases) of about 94.1 percent and a specificity (how well it detects negative cases) of 98 percent.


This test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative.


According to NBC, the testing kits — which cost $50 — will first be introduced in California and Florida "in the near future." They will be made available across the country in the spring of 2021.


"Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them," said Dr. Jeff Shuren, director of the FDA's devices center.









SOURCE:

https://www.lucirahealth.com/

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home?utm_medium=email&utm_source=govdelivery

https://www.nbcnews.com/health/health-news/fda-authorizes-first-home-covid-19-test-gives-users-results-n1248069


 

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