At-home COVID-19 test receives emergency approval by FDA

by Laura Mize · Dec 15th, 2020 4:08 pm

Twitter / Ellume

Last Updated Dec 17th, 2020 at 6:03 pm

An at-home, over-the counter test for COVID-19 received emergency approval from the U.S. Food and Drug Administration on Tuesday.

The test includes a swab and an analyzer that will connect via Bluetooth to the user's smart phone to report results within 15 minutes.

Ellume, the company behind the test, said that in people with symptoms of coronavirus, the test has correctly detected 96% of positives and 100% of negatives. In people without symptoms, the numbers are 91% of positives and 96% of negatives.

People who receive a positive result from an Ellume test should assume it is correct and isolate themselves from other people, but also seek a non-home test to confirm, the FDA advises. People who receive a negative test result should consult a doctor if they still show symptoms.

Ellume's test is slated to be available in early 2021 for around $30 or less.


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