New FDA-approved home coronavirus test doesn’t require a prescription

  • The FDA approved a new at-home coronavirus antigen test that delivers a diagnosis within 20 minutes.
  • The Ellume test presents the results via a smartphone app, and the diagnosis is shared anonymously with local public health officials.
  • The test will retail for $30 in the US this January, with Ellume looking to expand partnerships with retailers, companies, and universities.

The US Food and Drug Administration (FDA) approved a quick COVID-19 test that anyone over 14 can do at home a few weeks ago. The test delivers an immediate diagnosis, but there’s a huge caveat: You need a prescription to get one. But that test won’t be the only option for people looking for an affordable coronavirus test that they can perform at home, with a diagnosis ready in just a few minutes.

The FDA has now approved another quick test for home use, and this one doesn’t require a prescription. However, it does offer a smart feature that allows health experts to keep track of the results.

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Quick coronavirus antigen tests that can be done at home aren’t new, and the now FDA-approved Ellume test is similar to tests we’ve seen in the past:

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.

You get everything you need inside a box. You’ll use a swab to collect samples from your nose or throat, which will be mixed with a solution before the resulting sample is placed on a pregnancy-test-like device. The results are ready within 20 minutes.

To get the results, users will have to download an app on their smartphones. The app will also send the data anonymously by zip code to the cloud so that health officials will get positive results as well. Thus, the Ellume test corrects a problem of other quick tests. It informs public health officials about the number of infections tested with such methods.

Knowing how many people are infected at any given time is of huge importance for dealing with an virus, especially the novel coronavirus, which is surging in the US and around the world. But quick at-home prescription-free tests don’t usually requirement the patient to inform local public health officials or feature an automated way of doing so. The Ellume test solves that problem.

At-home tests do have other issues that people need to be aware of. Improper collection of samples might lead to a false-negative diagnosis. Rapid tests have been 90% to 97% accurate, which means they might miss some COVID-19 cases. The people who get false-negative results could then infect others, thinking they don’t have the virus. One of the reasons for testing negative after the infection is getting the test too soon after exposure to a COVID-19 patient. The virus has to incubate for several days before it’s detectable in swabs.

The Ellume test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, the FDA reported. In people without symptoms, the figures dropped to 91% and 96%, respectively.

The Australian company will charge $30 for the test, and the first batches will be available in January, Ellume told The Washington Post. The initial supply will be limited to 100,000 units, with manufacturing to increase to 1 million by the middle of 2021.

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Ellume chief executive Sean Parsons said the company would partner with a major US retailer, like Walgreens, CVS, or Walmart. They will also create policies to prevent hoarding. A negative test does not protect someone from an immediate infection if exposed to COVID-19 again. Some people might want to stock up on supply so they can get tested as often as they suspect an infection. The Post notes that some experts are worried that such tests might convince some people to disregard health precautions including health masks and social distancing. Ellume is also in talks to supply tests to companies and universities.

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he’s not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that’s not necessarily a bad thing.