The US gave the green light for the first Covid-19 home self-assessment diagnostic kit, adding an additional tool to combat the pandemic as nationwide testing capabilities come under increased pressure. The Food and Drug Administration issued an emergency use authorization for Lucira Health Inc.’s rapid results all-in-one test kit, according to a statement from the government agency Tuesday.
What is the Lucira test?
Currently, the Lucira test is licensed for prescription use only, and the FDA said healthcare providers must report all results to the government. Lucira’s test works by spinning the self-collected sample swab into a vial which is then placed in the test unit. Results can be read directly from the illuminated display of the test unit. In addition to home use, the product is also licensed for use in doctor’s offices, hospitals, and emergency rooms.
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How is this different from other Covid-19 tests?
While some Covid-19 tests allow people to provide samples from home, this is the first that can be fully self-administered and provide results at home in 30 minutes or less. The approval comes at a time when the country, which has the highest total number of cases in the world, with more than 11 million, is battling a fierce resurgence of infections. It could also help ease the strain on test labs that are overwhelmed by demand. But the full self-test is not widely adopted around the world, as it runs the risk of introducing human error and false results, and cases may not be reported to officials.
“This new testing option is an important diagnostic advance in addressing the pandemic and reducing the public burden of disease transmission,” FDA Commissioner Stephen Hahn said in the statement.
(with contributions from the agency)
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