Coronavirus tests: First at-home kit authorized by FDA

  • Testing for the COVID-19 coronavirus, in addition to contact tracing to help health workers zero in on the virus’ spread, will be significantly more important in the coming days as the Trump administration and state and local leaders around the US try to figure out how to reopen the country and economy responsibly.
  • Along those lines, the FDA on Tuesday announced its approval of the first at-home coronavirus testing kit, allowing patients to gather their own samples to be sent off to a lab for analysis.
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It was bound to happen eventually, and now the first coronavirus testing kit for at-home collection has been approved by the US Food and Drug Administration.

The FDA announced its approval on Tuesday of a home collection option for LabCorp’s COVID-19 RT-PCR Test, which allows the company to test samples patients have collected by utilizing the approved kit that contains nasal swabs and saline. Once patients have self-swabbed to obtain a sample, they mail it off inside an insulated package to LabCorp for testing — and LabCorp’s plan is to make this home collection kit eventually available to consumers in most states.

The LabCorp kit includes a Q-tip-style cotton swab, and patients are advised that other cotton swabs should not be used with this test because of concerns about sterility and the inherent genetic material in store-bought cotton swabs. “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,” FDA Commissioner Stephen M. Hahn said in a news release.

“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

It should go without saying, but since this authorization is categorized as the FDA’s first of an at-home test kit option for the coronavirus, this shouldn’t be read as a blanket approval for other at-home collection options using cotton swabs or other instruments. Today’s announcement is specific to LabCorp’s COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp home collection kit, which builds on the lab portion of the test that has already been approved — but it needed health care workers to collect the samples from patients.

As the US moves into the next phase of the coronavirus crisis, this kind of testing will be massively important. For the country and economy to reopen again, which will happen tentatively and in stages, a much larger degree of testing and contact tracing needs to take place, so that health care workers can even more intensely zero in on infected people to separate them from the healthy public.

The latest coronavirus numbers from Johns Hopkins University show more than 788,000 confirmed cases in the US since the COVID-19 coronavirus crisis began. Also to-date, there have been more than 42,000 deaths in the US.

Andy is a reporter in Memphis who also contributes to outlets like Fast Company and The Guardian. When he’s not writing about technology, he can be found hunched protectively over his burgeoning collection of vinyl, as well as nursing his Whovianism and bingeing on a variety of TV shows you probably don’t like.

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