FDA Authorizes New At-Home COVID-19 Test

  • January 14, 2021
With results delivered digitally in a matter of fifteen to twenty minutes, Ellume’s COVID-19 home test creates greater opportunities for more Americans to be tested and allows the spread of the virus to be lessened.

With COVID-19 cases rapidly increasing every day, the need for widespread testing has become necessary. Recently, the FDA issued an emergency authorization of an at-home testing kit that allows anyone to administer a test with results delivered in fifteen to twenty minutes. It is an antigen test that detects COVID-19 proteins through a less intrusive nose swab. What sets this particular test apart from other similar products is that anyone with or without symptoms is allowed to administer a test.

This test, created by Australian health company Ellume, is a kit containing a nasal swab, a testing strip, and a chemical solution with results delivered digitally onto a smartphone. Users will be required to add their birthdate and zip code, but also have the option to register their email and address for better tracking of the virus. This kit will be sold as an over the counter test for purchase at pharmacies and online. There will be an initial batch of limited supplies. However, the company has promised to produce over twenty million test kits by the first half of 2021.

The necessity for testing has become crucial in the scope of the current health crisis, as over a million confirmed cases are reported per week and in California alone, over 32,000 people are infected daily. With ICU capacities greatly waning, the need to conduct more testing becomes critical in preventing the further spread of the virus. Ellume’s test will provide quick and easy results for better statistics, especially with regards to its accessibility by the general public. With each test costing around $30, it will provide a more efficient way for people to screen themselves and self-quarantine.

Ellume’s test may have a small percentage of false negatives and positives, and if so, it is recommended to check false positives with a health professional. Of course, for people with symptoms, the test works much better, but there is still a 91% positive test and a 96% negative test accuracy rate for those who are asymptomatic. 

FDA commissioner Stephen M. Hahn has called this test a “major milestone” in regards to COVID-19 testing due to its easy accessibility and quick results and adds hope that testing laboratories will be less burdened. Ellume’s test is an innovation of what America needs most and shows hope that we may overcome this grave situation.

Information for this article comes from the New York Times, Associated Press, FDA, CDC

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