First COVID-19 diagnostic test authorized for home sample collection

Using a designated kit ordered by a doctor, patients will be able to self-swab and mail their samples to LabCorp testing facilities. The self-collection kits will be available in "most states" in the coming weeks.
By Dave Muoio
01:07 pm
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Thanks to an updated emergency use authorization (EUA) from the FDA, LabCorp's COVID-19 RT-PCR test is now the first diagnostic test for COVID-19 that permits at-home sample collection.

Now, patients may use Q-tip-style nasal cotton swabs and saline included in LabCorp's designated self-collection kit – which the company is branding as the "Pixel by LabCorp COVID-19 Test." These samples are mailed to a LabCorp facility in an insulated package for molecular testing.

LabCorp said in an announcement that it will initially be releasing these kits to healthcare workers and first responders with symptoms of COVID-19 or potential exposure to the virus. For consumers, the self-collection kits will be available in "most states" in the coming weeks, and will require a doctor's order, according to the FDA.

"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," FDA Commissioner Dr. Stephen M. Hahn said in a statement. "With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA stressed that this EUA only applies to LabCorp's offering, and does not apply broadly to other at-home COVID-19 sample collection products. The agency also said that it is looking into whether Q-tip-style cotton swabs such as these might be used to safely and effectively collect samples for other diagnostic tests.

WHY IT MATTERS

The U.S. is months into its battle against COVID-19 and still faces widespread testing shortages. While any new diagnostic tests for the disease will help healthcare teams better prioritize the highest-risk patients, an at-home sample collection option allows individuals to understand their condition without exposing anyone else in their communities.

As such, today's FDA authorization is a major step toward increasing access and limiting new infections among the public and healthcare workers alike. Time will tell whether other authorized molecular tests will receive similar authorizations – or whether providers may be able to avoid contact with symptomatic patients altogether by ordering these tests for their patients via telehealth.

THE LARGER TREND

Demand for at-home COVID-19 diagnostics has been clear for some time, particularly in mid-March when a spate of companies announced new home sample-collection services for molecular testing. However, each was forced to pump the brakes when the FDA clarified its policy and warned consumers that no such tests had yet been authorized. Many of these companies highlighted the ambiguity of the agency's guidance, but adjusted or axed their offerings to fall in line with regulatory requirements.

Similar confusions came to light among those developing serology tests for the disease in early April, with at least one company mistaking its response from the agency as an EUA and falsely marketing its service. It wasn't long after that Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test received the first authentic EUA for a COVID-19 serology test.

ON THE RECORD

"LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” Adam Schechter, president and CEO of LabCorp, said in a statement. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

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