FDA authorizes first COVID-19 test for at-home sample collection

Source:Xinhua Published: 2020/4/22 11:02:27

Medical workers work at a drive-through COVID-19 testing site in Dallas, Texas, the United States, March 21, 2020. The number of COVID-19 cases in the United States topped 20,000 as of 1:30 p.m. Eastern Standard Time on Saturday (1730 GMT), according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. (Photo by Dan Tian/Xinhua)
The U.S. Food and Drug Administration (FDA) authorized the first COVID-19 diagnostic test with a home collection option, said a release of the agency on Tuesday.

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 people at home, using home collection kit.

The kit includes a specific Q-tip-style cotton swab for people to use to collect their samples.

Once people self-swab to collect their nasal samples, they mail their samples in an insulated package to a LabCorp lab for testing.

LabCorp intends to make home collection kits available to consumers in most U.S. states in the coming weeks, according to the FDA.

The FDA has worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as accurate as sample collection at a doctor’s office, hospital or other testing sites, according to the agency.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen Hahn.

The FDA has authorized more than 50 diagnostic tests since the outbreak of the COVID-19 pandemic, he said.

The number of COVID-19 cases confirmed in the United States topped 823,000 as of Tuesday night, with over 44,800 deaths, according to data provided by the Center for Systems Science and Engineering at Johns Hopkins University.

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