WASHINGTON — The U.S. Food and Drug Administration has given the first authorization to an at-home coronavirus testing kit.
The kit, made by LabCorp, allows a person to collect their own samples with a specific Q-tip-style cotton swab at home. However, the tests do not give an immediate diagnosis. The kits have to be mailed to a lab for testing.
LabCorp said home kits will be available to consumers in most states, with a doctor’s order, in the coming weeks. The company said Tuesday in a release that the kits will initially be made available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic. On its website, LabCorp said that was because "initial quantities of kits are limited."
Eligible patients will need to answer a short survey before receiving a kit.
According to LabCorp's website, the kits cost $119 each.
Until now, the FDA had not authorized any at-home testing kits for coronavirus.
"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," Hahn added.
At this time, the FDA says generic cotton swabs should not be used with the test due to sterile and cross-contamination concerns. However, it is continuing to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests.
Politico said these tests can help cut down on the amount of personal protective equipment health providers are using while collecting patient samples for testing.
The FDA, an agency within the U.S. Department of Health and Human Services, works to protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
As of Tuesday, more than 2.5 million people have been diagnosed with COVID-19 worldwide.