COVID-19: FDA Approves First Rapid At-Home Test

The test kit eliminates the need for results to be sent to a lab

The test kit eliminates the need for results to be sent to a lab

Said FDA Commissioner Stephen M. Hahn: "The FDA continues to demonstrate its unprecedented speed in response to the pandemic".

The announcement by the Food and Drug Administration represents an important step in USA efforts to expand testing options for Covid-19 beyond healthcare facilities and testing sites.

The test is authorized for at-home use in patients over 14 who are suspected of having COVID-19 by their health care provider.

The prescription-only test can be used at home by people ages 14 and older, though it is available to all ages when given in a doctor's office, clinic or emergency room, with the swabbing being performed by a trained healthcare provider.

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The company's test allows users to swab themselves to collect a nasal sample.

People cannot only test themselves for COVID-19, but get rapid results at home, as the FDA authorized use of the first self-testing molecular single-use diagnostic to detect SARS-CoV-2 late Tuesday.

The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for Lucira Health's Covid-19 diagnostic test for self-testing at home. "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 SARS-CoV-2 virus".

The federal government this week authorized the first rapid coronavirus self-testing kit for use at home, an important step in fighting the ongoing pandemic and reducing the "public burden of disease transmission", officials said.

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People who receive a positive test result should isolate themselves and seek additional care if needed, while those who receive a negative result but still feel COVID-19 symptoms should follow up with their primary care physician, "as negative results do not preclude an individual from SARS-CoV-2 infection", according to the FDA. Most of those include nasal swab tests performed by healthcare experts and for the results, the samples need to go to laboratories.

Lucira Health said the tests were expected to initially roll out in California and Florida "in the near future".

According to Lucira Health, the tests have a sensitivity of about 94.1 percent and a specificity of 98 percent.

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