First nonprescription at-home coronavirus test has been approved

Here’s some good news. The first at-home test for the coronavirus that does not require a prescription has been approved by the Food and Drug Administration (FDA). LapCorp’s Pixel COVID-19 Test Home Collection Kit is intended for people 18 years of age and older.

The test kit allows the user to collect a nasal swab sample at home and send it to LabCorp for testing. The method of transmittal of the test’s result is determined on the urgency of the need for action or not. The customer will receive a phone call from a health care provider for a positive result or a result deemed invalid. A test that receives a negative result will be relayed via email or an online portal. The test kit can be purchased in a store or online.

From the FDA’s press release:

This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.

“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, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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.”

About a month ago, the FDA issued an emergency use authorization (EUA) for the first at-home test for coronavirus that provides rapid results. According to the FDA website, “the Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.” It is available for people ages 14 and older and it does require a prescription.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.

At-home test results should be monitored and tracked. The prescribing health care providers must report test results to relevant public health authorities, according to local, state, and federal requirements. Lucira Health, the test manufacturer has developed box labeling and instructions to assist with reporting.

Earlier this month, another at-home test was approved by the FDA – a COVID-19 and flu combination test, but it is not yet available. In order to receive this test, a person must be experiencing symptoms and a doctor’s prescription is required. Quest Diagnostics will then mail the test to the patient so that they can swab their nose and mail the sample back.If a person doesn’t feel comfortable collecting a sample at home on their own, they can go to a drive-thru testing site. The test costs $130 according to the Quest Diagnostics website.

David Strom 6:41 PM on September 26, 2022
David Strom 4:41 PM on September 26, 2022