- A test has been approved that doesn’t need a doctor
- Patients will swab their own noses to collect the sample
- The test will cost $119
The U.S. Food and Drug Administration (FDA) approved on April 21 the first COVID-19 diagnostic test that allows patients to collect their samples at home, according to a release from the FDA. But it’s not considered an at-home test, per say, since the patient can’t obtain the results on their own.
With the Pixel by LabCorp COVID-19 Test home collection kit, patients collect a sample from their nose using a provided nasal swab and saline. Once the sample is collected, patients mail the test back to LabCorp in an insulated package.
“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,” said FDA Commissioner Dr. Stephen M. Hahn in the release. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
This new test allows for in-home sample collection, but should not be considered an at-home test since the sample still needs to be shipped to the lab. The FDA has not yet approved any at-home diagnostic tests or at-home antibody tests.
LabCorp’s kit will initially be available to healthcare workers and physicians who may have been exposed to COVID-19 at work. The company plans for the test to be open to patients with a doctor’s order in most states in the coming weeks, according to the release. Consumers will have to pay $119 for the test out of pocket and then ask their insurance for reimbursement.
To ensure accurate results, the FDA recommends patients only use the specific cotton swab included in the kit, because other cotton swabs may not be sterile. Luckily, the swab included is a Q-tip-style swab—not the reportedly uncomfortable, longer swabs that patients have to stick deep in the back of the nose.
Additionally, the FDA specified that this authorization only applies to the LabCorp COVID-19 RT-PCR Test–it is not a general approval for at-home testing with other tests. Other start-up companies, including EverlyWell, Scanwell, and Nurx, had planned to release their own home tests in March but the FDA released a warning on March 20 that those tests could be considered “fraudulent” because the FDA does not authorize them.
Experts are still weighing the benefits and risks of at-home tests. At-home tests eliminate possible further exposure for both the doctor and the patient and decrease the need for highly in-demand personal protective equipment.
But Dr. Edo Paz, lead physician at K Health and a cardiologist at Heartbeat Health in New York, warned in an interview with CNet that at-home tests are more likely to be administered incorrectly when patients do it themselves and are at risk of becoming contaminated or damaged in the mail. It may also take longer to receive results due to shipping time.
Consumers should always consult with their doctor about their symptoms and whether an at-home test kit is the right choice for them.