New Delhi: The US Food and Drug Administration (FDA) Saturday granted emergency clearance to a Covid-19 testing kit that allows people to take a nasal sample at home and send it for testing.
The FDA issued an emergency use authorization (EUA) to American health firm Everlywell and it is the only kit that can be used with multiple authorised Covid-19 tests.
“Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit,” said the press statement issued by the FDA.
“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
The process — from placing the order of the kit to getting test results on phone or device — will take three to five days.
“The test kits will be available later this month and will cost $135,” the company’s spokesperson told The New York Times.
The FDA had earlier granted EUAs for diagnostic tests that permit testing of saliva samples collected by patients at home.
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How does the kit work?
The kit and associated tests are available by prescription only in the US.
The kit consists of nasal swabs, which allow an individual to collect a sample from inside the patient’s nose, and a tube filled with saline to transport the sample back to a specified lab.
“Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests authorized under a separate EUA for use with the Everlywell at-home sample collection kit,” explained the FDA’s statement.
However, according to reports, some public health researchers have warned that “at-home nasal swab tests can be less accurate than the specimen collection performed by health care providers, which involves inserting a long nasal swab through the nose into the back of the throat”.
Also read: FDA has approved saliva test to detect Covid-19 that lowers infection risk for health staff