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Regulatory Focus™ > News Articles > 2020 > 4 > FDA authorizes first COVID-19 test for at-home sample collection

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

Posted 21 April 2020 | By Michael Mezher 

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

Credit: CDC/ C.S. Goldsmith and A. Tamin

The US Food and Drug Administration (FDA) on Tuesday granted an emergency use authorization (EUA) to LabCorp allowing it to test self-collected nasal swab samples from patients for coronavirus disease (COVID-19) with its COVID-19 RT-PCR Test.
 
FDA first granted LabCorp an EUA for the test on 16 March, but limited sample collection to upper and lower respiratory specimens collected by healthcare providers.
 
The newly reissued EUA marks the first time FDA has authorized at-home sample collection for a COVID-19 test and specifically applies to sample collection using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. (RELATED: FDA: Flexible COVID-19 testing policy doesn’t apply to at-home tests, Regulatory Focus 24 March 2020).
 
In a statement, FDA Commissioner Stephen Hahn said that FDA worked with LabCorp to ensure testing of self-collected samples “is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site.”
 
LabCorp said it will prioritize the initial distribution of the at-home test kits for health care workers and first responders and that it plans to make the kits available to consumers with a doctor’s order “in the coming weeks.” The test kits are available for shipping to 46 states from LabCorp’s website for $119 after completing an eligibility survey.
 
While the EUA permits at-home sample collection, the testing itself must be conducted at LabCorp’s Center for Esoteric Testing and other Clinical Laboratory Improvement Amendments (CLIA) certified high complexity laboratories designed by the company.
 
The sample-collection kit itself features a nasal swab and packing materials so patients can safely mail specimens to authorized laboratories for testing.
 
The EUA also includes several conditions for LabCorp to follow, including providing fact sheets for health care providers and patients and standard operating procedures for performing the tests to authorized laboratories.
 
FDA, EUA, Press Release

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