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The FDA issued the emergency use authorization to the Laboratory Corporation of America (Labcorp) to test samples that are self-collected by patients at home using the company’s COVID-10 Test home collection kit.
According to the FDA, the 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 outlet for testing.
The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample. Due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with the test, the FDA noted.
“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,” FDA Commissioner Stephen Hahn said. “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.”
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