FDA authorizes the first diagnostic test with an at-home sample collection for Covid-19

Users of the test must still mail the sample in to LabCorp.


 

The FDA authorized the first diagnostic test with an at-home sample collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. Today’s reissued EUA permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.

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Submitted by New Fairfield, CT

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