UPDATE 4/21, 5:25 p.m. ET: The Food and Drug Administration has authorized diagnostics company LabCorp's Pixel at-home COVID-19 test kit, the agency said in a news release on Tuesday. It is the first at-home COVID-19 test that has been authorized by the FDA. Samples collected from the Pixel test will be mailed back in via an insulated package for analysis. Patients will use "a specific Q-tip-style cotton swab" to collect the sample from their nose.
The tests will first become made available to front-line workers. Others should be able to get the test “in the coming weeks," which will cost $119, the company said, per the New York Times.
"Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," FDA Commissioner Stephen M. Hahn, M.D. said. "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. 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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home."
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The Food and Drug Administration announced Friday that people may soon be able to engage in "safer at-home coronavirus testing."
PerCNN, the FDA said it's collaborated with US Cotton for a newly designed Q-tip-style swab exam that notably uses swabs that are shorter than the ones currently used by doctors and nurses for collecting samples used in COVID-19 tests.
"We appreciate work by UnitedHealth Group, Quantigen, and the Gates Foundation to perform and support the clinical studies necessary for this advancement," FDA Commissioner Stephen M. Hahn said in a press release. "We also want to acknowledge US Cotton's efforts to manufacture a new type of swab for COVID-19 testing that can be produced at scale."
Considerations are being made, Hahn added, regarding how the supplies can help meet testing needs at the global level.
"All of these actions by these American organizations will help continue to expand our testing capability," Hahn said.
The revelation that spun synthetic swabs could be used for testing was inspired by findings taken from a clinical investigation by the FDA, the Gates Foundation, Quantigen, and UnitedHealth Group. Front of the nose testing, the type used in the study, "is notable" due to its allowance of self-collection which limits potential exposure to the virus by healthcare workers and others.
The total number of COVID-19 cases in the US had topped 632,000 at the time of this writing, with more than 31,000 reported deaths. For current info on how to maneuver through day-to-day life in the era of coronavirus, click here.
