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Jeff Shuren

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COVID-19: FDA Authorizes Test That Detects Virus In Breath COVID-19: FDA Authorizes Test That Detects Virus In Breath
Covid-19: FDA Authorizes Test That Detects Virus In Breath Federal authorities have authorized the first device that can detect COVID-19 in breath samples. The Food and Drug Administration (FDA) issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer, which can be used in doctor’s offices, hospitals, and mobile testing sites to quickly identify the virus. According to officials, the device is 91.2 percent accurate at identifying positive test samples and 99.3 percent accurate at diagnosing negative samples. The FDA said that the instrument is approximately the size of a piece of carry-on luggage, and the test can be performed…

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by Zak Failla
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COVID-19: FDA Approves Home Test, Calls Moderna Vaccine 'Highly Effective' COVID-19: FDA Approves Home Test, Calls Moderna Vaccine 'Highly Effective'
Covid-19: FDA Approves Home Test, Calls Moderna Vaccine 'Highly Effective' The Food and Drug Administration approved the first over-the-counter COVID-19 test involving a nasal swab that provides results in under a half-hour and is now likely to give an OK to Moderna’s COVID-19 vaccine, which it dubbed “highly effective." The new home test for COVID marks the first that doesn’t have to be sent to a lab to receive the results. Health officials with the FDA have authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. “By …

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by Zak Failla
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COVID-19: FDA Approves First Rapid At-Home Test COVID-19: FDA Approves First Rapid At-Home Test
Covid-19: FDA Approves First Rapid At-Home Test The Food and Drug Administration has approved the first rapid at-home COVID-19 test that could have results returned within an hour. The FDA issued an emergency use authorization on Tuesday, Nov. 17 for the "Lucira COVID-19 All-In-One Test Kit," a single-use test that will detect the novel coronavirus SARS-CoV-2 that causes COVID-19. The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the S…

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by Zak Failla