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The FDA just approved the first rapid at-home coronavirus test

Published Nov 18th, 2020 9:05PM EST
Image: Microgen/Adobe

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  • The FDA just approved the first at-home coronavirus test that delivers immediate results.
  • The Lucira Health test kit will cost less than $50 and should be available nationwide by spring through healthcare providers.
  • Anyone over the age of 14 can use the test, which will provide a diagnosis within 30 minutes.

The faster people who are infected with the novel coronavirus get tested, the faster they can isolate and avoid infecting others. That’s where rapid, accurate, at-home testing might help, especially when the virus is spreading rapidly inside communities. It just so happens that the virus is out of control in the US and other countries, as the fall wave has gone to much higher highs than the one in spring. The US has been breaking the world record for the number of daily cases for a couple of weeks, topping at over 177,000 cases on Friday. Experts warn that might not even be the peak of the current wave, especially with Thanksgiving approaching.

One thing that might come in handy is the first prescription at-home coronavirus test that the FDA just approved. The Lucira Health test delivers results in less than 30 minutes. The fast results would not just help with containment efforts but would also help individuals isolate earlier and seek treatment.

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The test kit includes everything you need to perform a COVID-19 test at home, and it’s suitable for use for anyone of at least 14 years of age, according to the FDA announcement.

People will have to use a swab to collect a sample from inside the nose. They’ll then place the swab in a vial, give it a swirl, and place the vial in a test unit, as seen in the following image. The result should be processed within 30 minutes.

Coronavirus Test
Lucira Health’s at-home coronavirus test kit. Image source: Lucira Health

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” FDA medical device director Jeff Shuren said of the test, per Politico.

Importantly, the health care providers who prescribe the tests will have to report the results to public health authorities. That’s actually a feature that goes beyond what’s expected from a fast COVID-19 test, and it should help local authorities get a better estimate of the local spread of coronavirus.

The test isn’t perfect and might lead to some false results. Politico notes that the test’s instructions explain that it correctly identified 94% of positives and 98% of negative samples using a more sensitive lab-based test in a study. “Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement,” the same instruction said. In real-life conditions, a person would not know how high their levels of the virus would be to get an accurate diagnosis.

Still, the test is definitely useful and might prompt more people to seek urgent testing when they suspect they may have been infected. The FDA has approved at-home testing before, but this is the first one that actually offers results on the spot.

Some experts think that widespread at-home testing could help bring the pandemic under control in the US. “I believe very firmly that if we asked 100 percent of Americans — maybe we wouldn’t get there — to get tested weekly, we could do it,” Harvard University epidemiologist Michael Mina told Politico. He also said that a second at-home test using a different approach could be used to reduce the number of false positives.

The test will cost less than $50 and is manufactured in the US. The first locations to get access to it will be Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale. It should be available nationally by spring 2021. More details about the test are available on the Lucira Health website.

Chris Smith Senior Writer

Chris Smith has been covering consumer electronics ever since the iPhone revolutionized the industry in 2008. When he’s not writing about the most recent tech news for BGR, he brings his entertainment expertise to Marvel’s Cinematic Universe and other blockbuster franchises.

Outside of work, you’ll catch him streaming almost every new movie and TV show release as soon as it's available.

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