Regulators at the U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that lets people collect a sample at home.

The authorization of the diagnostic — developed by testing giant LabCorp —  marks the first time the agency has cleared an at-home Covid-19 test and caps weeks of back-and-forth between the agency and startups who sought to develop their own versions of the tests that would allow for at-home sample collection. LabCorp’s test will initially be made available to health care workers and first responders who might have been exposed to the virus. Patients can collect samples at home if the test is recommended by a health care provider after they’ve completed a questionnaire about Covid-19, and results are expected to be available within one to two days after a sample reaches the lab, according to LapCorps’ website.

“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 Hahn said in a statement on Tuesday.

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“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.

The FDA had already cleared LabCorp’s test in March under regulations known as an emergency use authorization, geared specifically for situations such as the coronavirus pandemic. On April 5, the company reached out to FDA to ask that it amend that authorization to allow for patients to use it at home. LabCorp’s at-home test uses a specific Q-tip-style cotton nose swab, as opposed to previous, longer swabs that required patients to sample themselves deep in the back of the nose. Experts had previously expressed concerns to STAT about the viability of people testing themselves at home using kits that involve longer swabs, which are uncomfortable when done properly.

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The agency’s authorization of the LabCorp test for home sample collection comes after a previous flurry of activity between the agency and companies including Nurx, Carbon Health, and Everlywell, all of which had sought to have their own Covid-19 tests approved for at-home use in March.

Confusion over the FDA’s rapidly shifting guidelines appeared to lead some companies to initially believe their tests were in the clear. On March 21, federal regulators issued stern guidance which clarified that no home tests had yet been approved for use and warned consumers to be wary of “unauthorized fraudulent test kits.” In response to the warning, all three companies stopped selling their kits directly to consumers.

In April, two other companies began selling Covid-19 tests that let people collect saliva samples at home. The two companies — MicroGen DX and Vault Health — told STAT on April 10 that their tests were cleared for patients to collect spit samples at home. The companies insist they are permitted to sell the tests because they are ordered by physicians and processed in certified labs. The FDA, however, remained adamant that isn’t the case, repeating its previous guidance to STAT on April 10 and emphasizing that the agency “had not authorized any Covid-19 tests for home use, including home collection.” Those tests have still not been cleared for home sample collection.

  • Frankly, I don’t see this test as very helpful because a) you have to mail in the sample- really sending a highly infectious agent in the mail- which bone head came up with that, b) you don’t get the results instantly like a pregnancy test, c) the test is still restricted and inaccessible to the
    public. We the people want a test at home that give us the result and the lab can pick up the kit for further testing. We build rockets, send people to the space station, we can come up with a test at home that give the results right away.

  • Does Lab Corp have sufficient reagents to handle a large influx of swabs? Why isn’t this test open to all?

    • This test obviously is only available to those who can affort it – leaving many who need it out of reach – and LabCorp profiteers from sick and worried people. It is stupefying that such a test is not free – typical US approach.

  • The novel coronavirus spreads through the air as a result of coughing, sneezing, or even breathing by infected people. So we are asked to wear masks, not so much to protect uninfected people from catching the virus, but to prevent infected people from spreading the virus through the air.

    If that’s the case, why don’t these any of these coronavirus tests collect breath samples from people, instead of using nose swabs? Couldn’t a collection method be devised by having test subjects exhale through a tube into some liquid medium that collects the virus particles?

    Just wondering if there’s some reason why this would not be feasible.

  • This may sound great but the idea of many samples of the coronavirus being transported in the mail sounds like a recipe for disaster. Even in hospitals, it is hard to control the spread of it, but to have people put it into containers for shipping elsewhere is radically dangerous. I personally would like to be able to do that but I don’t think it is a good idea at all.

    • I’ve got some bad news. Hundreds of thousands of
      infectious samples are shipped daily via FedEx, UPS,
      and USPS during the normal course of the lab business.
      Specimens known or suspected of being infectious are
      subject to heightened safety requirements for shipping
      mandated by DOT/IATA.

    • Why should I pay for this kit? $119 is not exactly cheap. Does it include a FedEx preprinted label in the box?

      “send it back to our world-class lab for testing”

      Is the lab possibly in China? How long does it take to get there and how much longer to get my result? Has the test been certified by the FDA? Is it a viral RNA (PCR) test or serology antibody test?

      Sounds very fishy to me….

      it be covered by my health insurer?

  • Where or how do I purchase two at home Clovis 19 tests. My husband has an auto immune disease, kidney problems, and heart problems. Thank you!

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