FDA authorizes first over-the-counter fully at-home COVID-19 test

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FDA authorizes first over-the-counter fully at-home COVID-19 test
tjordan_drupal
Dec 15, 2020

The Food and Drug Administration today issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19. The antigen test for persons age 2 and older can detect the SARS-CoV-2 virus in a nasal swab sample in about 20 minutes. The new Ellume COVID-19 Home Test is less sensitive and specific than typical molecular tests run in a lab, but “the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. 

In other news, FDA yesterday approved an abbreviated new drug application for midazolam injection, a drug in short supply used to sedate intubated and mechanically ventilated patients and in critical care settings. 

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FDA authorizes first over-the-counter fully at-home COVID-19 test
tjordan_drupal
Dec 15, 2020

The Food and Drug Administration today issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19. The antigen test for persons age 2 and older can detect the SARS-CoV-2 virus in a nasal swab sample in about 20 minutes. The new Ellume COVID-19 Home Test is less sensitive and specific than typical molecular tests run in a lab, but “the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. 

In other news, FDA yesterday approved an abbreviated new drug application for midazolam injection, a drug in short supply used to sedate intubated and mechanically ventilated patients and in critical care settings. 

Novel Coronavirus (SARS-CoV-2/COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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