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FDA Authorizes Coronavirus Test That Uses Samples Collected at Home

TUESDAY, April 21, 2020 (HealthDay News) — The U.S. Food and Drug Administration has approved emergency use of the first COVID-19 test that enables patients to take samples at home.

The authorization is for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to test samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit, the agency explained.

For “tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” FDA Commissioner Dr. Stephen Hahn said in an agency news release.

Patients use a self-collection kit that contains nasal swabs and saline. After self-swabbing to collect their nasal sample, patients mail their sample, in an insulated package, to a LabCorp lab for testing.

LabCorp plans to make the home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks, according to the FDA.

It said this authorization only applies to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit, and is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.

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