FDA Approves America’s First Prescription COVID-19 Home Testing Kit
The FDA announced on the 17th that the first COVID home test that provides rapid results has been approved in the United States.
The test is available by prescription and is licensed for use at home with nasal swabs for people 14 years and older whose doctor suspects they might be infected with COVID-19.
“While COVID-19 diagnostic tests have been licensed for collection at home, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Stephen Hahn in a statement.
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Designed to produce results in 30 minutes or less, the Lucira all in one has demonstrated 100% efficacy with a sufficiently rich sample and 94-98% positive-negative diagnostic accuracy with a limited sample.
The test is expected to cost around $ 50 and generates results by spinning the test swab in a vial included in the test.
Until now, the tests have been done in a clinic, which can deter people due to the perceived risk of contracting the virus there, and even afterwards, the sample would have to be carefully handled, labeled and followed as it is sent to a laboratory for analysis. .
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A home version expands testing options for people in difficult health or financial situations.
Those under the age of 14 must have the test administered by a health care professional.
“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 Jeff Shuren, chief of the FDA at the Center for Devices and Radiological Health.
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