FDA Authorizes At-Home COVID-19 Test; Results Provided in 1-2 Days

Brooklyn and Beyond


The FDA has granted emergency use authorization to an over-the-counter, non-prescription COVID-19 test for at-home use.

Pixel by LabCorp offers self-testing kits "at no upfront cost to those who meet clinical guidelines". LabCorp can bill any health insurance, or it can use federal funds to cover the cost of this test for those who are uninsured. Those who don't want to utilize either option can opt to pay out of pocket using a credit card.

“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, president and chief medical officer of LabCorp Diagnostics, in a press release. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

The at-home COVID-19 test from LabCorp isn't new. These tests have been available to consumers via overnight shipping (and next day pickup) for several months. The emergency use authorization issued by the FDA allows LabCorp to distribute their tests in retail stores, reaching consumers who might not otherwise be able to access testing, even if they haven't been prescribed testing by a medical professional.

"While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing," said Dr. Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, in a recent statement.

Results of the LabCorp test come in 1-2 days, either via an online portal (for negative results) or a phone call with further instructions (for positive or invalid results).

"Our FDA authorized COVID-19 collection kits provide everything you need to collect a nasal swab sample and send it back to our lab," LabCorp explains on their website. "LabCorp is reserving access to kits for individuals experiencing symptoms or those who have been asked to get tested by a healthcare provider, public health department, or contact investigator."

Are self-swabs reliable?

According to a small study by the Stanford School of Medicine, self-swabs are safe and reliable, with results from self-swabs matching results from swabs taken by medical providers 29 out of 30 times.

Allowing patients to swab themselves -- from home, in particular -- keeps them from having to wait on lines or in urgent care centers, where they could test negative that day but find out later that they contracted the virus at the testing site.

Self swabbing may also encourage those who are reluctant to have a deep nasal swab to get tested regularly, as these swabs only go about a half inch into the nostril. (The CDC no longer recommends the deep nasal swab, instead recommending inserting the swab "less than an inch", or approximately 2cm, into the nose.)

COVID-19 testing capacity has increased significantly since the early days of the pandemic, when only those with the most severe symptoms were eligible for testing. The majority of testing was performed via deep nasal swab in hospital settings, and results took over a week to come back. There were no guidelines on social distancing, there were no mask mandates, there were no antibody tests, and if you didn't have symptoms, you weren't getting a test.

The emergency use authorization issued for Pixel by LabCorp's over-the-counter PCR test makes it easier to get tested, even if you don't live near a testing site.

Consumers can complete the test in minutes by swabbing the inside of both nostrils, inserting the swab into a tube of saline solution, putting the tube in a biohazard bag, and re-packaging the contents. The package must be picked up (or dropped off) for next-day delivery.

In addition to approving LabCorp's at-home test, the FDA issued an emergency use authorization for Pfizer's vaccine on Friday. The 2-dose vaccine will be administered to millions before the end of the year.

Meanwhile, the COVID-19 pandemic continues to ravage the United States, leaving nearly 300,000 dead.

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