On Tuesday, the Food and Drug Administration approved the first at-home test for the novel coronavirus, as reported by CBS News. The test kit, which is called Pixel, is being produced and sold by LabCorp, a clinical laboratory based in Burlington, South Carolina. LabCorp stated that the tests would first be made available to healthcare workers and first responders. The company also said that priority will go to workers who know they have been exposed to the virus.
The test kits are expected to go on sale to the general public “in the coming weeks.”
According to the report, the Pixel test kits will allow people to reliably test themselves for COVID-19 without having to visit a drive-through testing site or a medical provider’s office. The test kit comes with a sterile nasal swab and instructions on how to collect a sample. Once the sample is taken, it is sent back to LapCorp for processing at one of their laboratories. It’s still unclear how long it will take to get results from the at-home tests.
To get the at-home coronavirus test kit, people must complete a survey to determine whether or not they’re eligible. If they are, a Pixel test kit will cost them $119. LabCorp’s website said that the tests would not be available in Rhode Island, Maryland, New York, or New Jersey. New York and New Jersey currently have the highest rates of coronavirus infection in the country.
Politico reported that it’s currently not clear whether LabCorp will be able to keep up with the demand for at-home tests. A spokesperson for LabCorp told Politico that it’s too early to know how many tests they will need to manufacture and that the number of tests initially available would be “limited.” Their goal is to provide tests to people who know they have been exposed and people who are currently showing symptoms.
The FDA used emergency approval measures to ensure that the tests would be available sooner. Stephen Hahn, the FDA Commissioner, stated that they went through a rigorous process to ensure that the tests provide accurate results.
“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 also warned the public against purchasing other at-home test kits that are being marketed on social media.
“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.”
He stressed that the test kit produced by LabCorp is the only test on the market approved by the FDA.