FDA authorizes first at-home collection coronavirus test kit

April 23, 2020

The test kit allows a patient to collect their own sample keeping healthcare workers out of the line of fire.

The U.S. Food and Drug Administration (FDA) has approved the first COVID-19 coronavirus test kit that allows patients to collect their own samples at home.

According to a news release, the FDA reissued an emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test which allows patients to collect their own nasal samples at home protecting healthcare workers from possible infection during sample collection.

“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 M. Hahn, MD, says in the release. “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.”

The EUA permits testing to be performed on samples collected from the patients nose by a designated self-collection kit made up of nasal swabs and saline. Once the sample is collected, the patient can mail their sample in an insulated packaging to a LabCorp lab for testing. The collection kits are expected to be made available to consumers in most states, with a doctor’s order, in the coming weeks, the release says.

Only the specific Q-tip-style cotton swab contained in the kit should be used for collecting samples because of concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs. The FDA is continuing to study whether or not Q-tip-style swabs can be used safely and effectively with other tests, the release says.

The EUA only applies to this specific LabCorp COVID-19 RT-PCR Test 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 in the home, the release says.