FDA Grants EUA to LabCorp's At-Home COVID-19 Test Kit
This test kit was developed to both increase the supply of COVID-19 tests for first responders and frontline health care workers who develop symptoms of COVID-19.
The US Food and Drug Administration (FDA) has issued an emergency use authorization to LabCorp for at-home coronavirus disease 2019 (COVID-19) tests kits.
Under this authorization, nasal swab specimens can be collected at home using the Pixel by LabCorp COVID-19 collection kit. A health care provider must recommend the test and patients must complete a COVID-19 questionnaire prior to testing.
This test kit was developed to both increase the supply of COVID-19 tests for first responders and frontline health care workers who develop symptoms of COVID-19. The at-home, self-administered test can help prevent further transmission of the virus and also reduce the need for personal protective equipment.
According to a statement issued by the FDA, the kit includes a specific cotton swab for sample collection. Other cotton swabs should not be used with this test due to concerns with sterility and cross-reactivity as a result of inheret genetic material in cotton swabs. Once patients self-swab to collect a nasal sample, the sample is then mailed, in an insulated package, to LabCorp for testing.
Initially, the kits will be made available to frontline health care workers and first responders. In the coming weeks, LabCorp plans to make the tests available to consumers.
“Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time,” Adam Schechter, president and chief executive officer of LabCorp said in the announcement.
This home test kit is only authorized under emergency use authorization. The test should only be used to detect nucleic acid for SARS-CoV-2, not for any other viruses or pathogens.
"The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, 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," Stephen Hahn, MD, commissioner of the FDA said in the agency's statement.