At-home Covid-19 testing takes another leap

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After last week’s emergency use authorisation of an antigen test, the US FDA has now given the nod to a new kind of diagnostic technology for Covid-19: not a test at all, but a kit that patients can use at home to collect their own nasal samples. The kit is made by the private US company Everlywell, and can be used by people who have been screened using an online questionnaire, reviewed by a healthcare provider. Everlywell’s kit can be used with two coronavirus RNA tests, both of which received separate, individual EUAs: Fulgent Therapeutics’ Covid-19 by RT-PCR test and Assurance Scientific Laboratories’ Sars-CoV-2 panel. In both cases the sample is shipped to these companies’ own laboratories for testing. The FDA said that other tests may be authorised for use with the Everlywell at-home collection kit in the future, provided their manufacturers submit an EUA request including data that demonstrate the accuracy of the test when used with the kit. To date, the regulator has awarded EUAs to two other molecular Covid-19 tests that use home sample collection: LabCorp’s Pixel and an academically-developed test that uses saliva rather than nasal or throat swabs.

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