The only-use take a look at, made by Lucira Well being, has been given emergency use authorization for house use with self-collected nasal swab samples in people aged 14 and older who’re suspected of COVID-19 by their well being care supplier, the FDA mentioned.
“Whereas COVID-19 diagnostic assessments have been approved for at-home assortment, that is the primary that may be totally self-administered and supply outcomes at house,” FDA Commissioner Stephen Hahn mentioned.
The equipment may also be used at hospitals and point-of-care settings however samples ought to be collected by a healthcare supplier if the people who’re examined are youthful than 14 years, the well being regulator mentioned.
Though a current string of optimistic information from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the illness, testing nonetheless is a key think about controlling the unfold of the virus.
“We sit up for proactively working with take a look at builders to assist the supply of extra at-home take a look at choices,” mentioned Jeff Shuren, the director of the FDA’s Middle for Gadgets and Radiological Well being.
The US crossed 11 million complete infections on Sunday, simply eight days after reaching the ten million mark.
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