Home coronavirus test kits approved by US FDA after initial delay
The US FDA has now updated its position on the legitimacy of at-home coronavirus test kits, granting an emergency use authorization to LapCorp.
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The US FDA has now updated its position on the legitimacy of at-home coronavirus test kits, granting an emergency use authorization to LapCorp.
The US Food and Drug Administration (FDA) has now updated its position on the legitimacy of at-home coronavirus test kits, granting an emergency use authorization for LapCorp’s Pixel home collection kits. The kits are set to be made available in most states in the next few weeks.
One month ago, the FDA made an effort to crack down on the “market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic.” The administration mentioned that any at-home test kit was likely the result of those aiming to take advantage of a vulnerable situation, and urged all citizens to refrain from conducting a test themselves.
And now LapCorp, which launched its lab test for the contagion back in March, has been approved to distribute its at-home test kit, Pixel.
“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 Dr. Stephen Hahn said in a statement.
LapCorp said in a release that the kits would initially be made available to healthcare workers and first responders who may have been exposed to COVID-19. The reason given is that initial quantities are in limited supply.
Users will collect a sample from their nose using the Q-tip-style cotton swabs and saline included in the kit, and will then mail it to LapCorp for testing.
“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,” the FDA 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,” Hahn said in the announcement.
“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,” he added.
Results could still take up to two weeks, after mailing and lab work is completed. Kits cost $119 each.
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