The first at-home diagnostic test kit to detect Covid-19 infection has been authorized by the US Food and Drug Administration (FDA) under an emergency use authorization.
However, the test has not been approved or cleared by the agency and is only allowed during a period of time that “circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis,” notes test-maker Laboratory Corporation of America (LabCorp) in a press release.
“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers," said FDA Commissioner Stephen M. Hahn, M.D., in a statement. "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."
The authorization permits LabCorp’s Pixel collection kit to test for the presence of SARS-CoV-2, the coronavirus responsible for Covid-19, in samples collected at home. The molecular test determines whether a person is currently infected with the novel coronavirus and does not determine whether they have been previously infected. (Though there is an upcoming National Institutes of Health study set to answer that very question.) Test kits will first be made available to health care workers and first responders who may have been exposed to the virus before rolling out to consumers in most states with a doctor’s order in the next few weeks.
The 12-step instructions direct patients to first complete an online survey and if deemed eligible, they can buy the FedEx-shipped test kit for $119. Patients can take a sample from their nose using a Q-tip-style cotton swab and saline. Collected samples are then mailed in an insulated package directly to LabCorp for testing.
LabCorp notes there is still a possibility the tests may produce false negatives either due to inadequate collection techniques by the user or because of the nature of the virus. Symptoms typically appear between two and 14 days after being exposed to the virus, according to the Centers for Disease Control and Prevention. If feeling sick, health care officials recommend calling a doctor or consulting a healthcare professional through teleservices before an in-person visit. Go to the hospital if emergency warning signs develop.