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In December, the FDA authorized the use of a rapid testing kit developed by Brisbane, Australia-based Ellume Health. The test is available for purchase without a prescription for about $30 and can give results in about 20 minutes. [62] [63] The FDA approved the test for people with and without COVID symptoms. [63]
New Covid boosters from Pfizer and Moderna are now available at pharmacies nationwide, and the US is restarting its free Covid test program. Tests can be ordered from COVIDTests.gov starting ...
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On 15 December, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. [ 107 ] [ 108 ] [ 109 ] The 'Ellume COVID-19 Home Test' is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with ...
The government has reinstated its program to offer free COVID-19 tests to Americans. Each household can receive a set of free at-home COVID-19 tests.
COVID-19 rapid antigen tests (RATs) have been widely used for diagnosis of COVID-19. The World Health Organization (WHO) COVID-19 Case Definition states that a person with a positive RAT (also known as an antigen rapid diagnostic test or Antigen-RDT) can be considered a "confirmed case of SARS-CoV-2 infection" in two ways. [10]
The government also announced earlier this month that private health insurance companies are now required to cover up to eight at-home COVID-19 tests per person per month for free. So, a family of ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...