4/21 FDA News Release

Angie Szumlinski
|
April 27, 2020
Corona Virus - Microbiology And Virology Concept - 3d Rendering

Coronavirus (COVID-19) Update: FDA Authorizes First Test
for Patient At-Home Sample Collection

Last week the FDA authorized the first diagnostic test with a home collection option for COVID-19. This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once 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.

https://www.fda.gov/media/136148/download

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-patient-home-sample-collection


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