First At-Home Over-the-Counter COVID-19 Test Kit Granted Emergency Approval

The first nonprescription COVID-19 test, available for online order, may soon be in stores.

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for LapCorp’s Pixel COVID-19 Test At-Home Collection Kit, the first at-home COVID-19 test kit that doesn’t require a doctor’s prescription for purchase.

The approval, announced by the FDA on December 9, will allow people older than 18 to collect their own nasal swab at home and send it to LabCorp for analysis and results. 

Positive or invalid test results are delivered to the user by a healthcare provider. If a person tests negative, the results are sent via email or an online portal. Once the test is received at the LabCorp facility, average time to deliver the results is currently one to two days, according to the company’s website

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, MD, the director of the FDA’s Center for Devices and Radiological Health in a statement by the agency. “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. Shuren.

Tests that don’t require a prescription are a step forward, but this product is a home collection device, not a true home test, says Amesh Adalja, MD, an assistant professor and senior scholar at the Johns Hopkins Center for Health Security in Baltimore who specializes in emerging infectious disease. “The sample still has to be sent to a lab. It is not a home test,” he says.

Ideally, there will eventually be a test that is available without a prescription, is cheap, and returns a result in a few minutes right at home, says Dr. Adalja.

On an individual level, testing allows people to know their status so they can know what is safe and what’s not safe for them to do, says Adalja. “Also, test results can help inform public health decision-making by elucidating how people are getting infected; it is key to contact tracing efforts,” he says. Access to testing is an important part of efforts to contain COVID-19, says Adalja. “Testing is a key component of a layered approach to prevention that includes face coverings, hand-washing, and social distancing,” he says.

Currently Available Online, Kit May Be Sold in Stores Soon

The Pixel kit requires the consumer to complete a short eligibility survey about their symptoms. Currently, the company is reserving the kits for people who are experiencing symptoms, have been exposed to someone with COVID-19, or who have been recommended for testing by a healthcare provider, public health department, or contact investigator, according to LabCorp.

If a person reports severe symptoms when filling out the online questionnaire, they are directed to get in touch with their local healthcare provider immediately.

The next step requires people to select one of three options to pay for the kit.

  • You can choose the option of paying nothing up front and have your insurance billed.
  • If you’re uninsured, there is an option to have LabCorp access federal funding that reimburses providers for the test.
  • You can pay out of pocket for the test, which costs $119, according to the company’s website.

Once the kit is ordered, the next steps are as follows:

  • The sample collection kit will be sent to your home via FedEx.
  • You perform a nasal swab that requires insertion until the cotton tip of the swab is no longer visible — not a deep nasal swab.
  • After following the instructions on swabbing each nostril, you place the swab in the collection tube and put it in the provided prepaid, pre-addressed packaging.
  • The sample must be returned at a FedEx facility or drop box.

Currently the kit is available only through the LabCorp website, but the company says the test may be available in retail stores soon, according to a release.

The Pixel is a PCR test for SARS-CoV-2, the virus that causes COVID-19, one of the two types of diagnostic tests for the virus. Molecular tests, such as an RT-PCR test, detect the virus’s genetic material, and antigen tests look for specific proteins from the virus, according to the FDA

The PCR test is less likely to give a false positive than an antigen test, according to the to the FDA.

If a person does get a positive result, the healthcare provider who delivers the results will offer assistance regarding healthcare treatment and next steps, according to the LabCorp statement.

Article first published on EveryDayHealth

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