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FDA issues emergency use authorization for first over-the-counter coronavirus test

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On Dec. 15, the U.S. Food and Drug Administration issued an emergency use authorization of the first at-home, prescription-free coronavirus test from Ellume Health. That same day, the country reported nearly 3,000 deaths from the virus. "Hands in yellow rubber gloves holding Coronavirus test tube" by wuestenigel is licensed with CC BY 2.0.

On Tuesday, the U.S. Food and Drug Administration issued an emergency use authorization for the country’s first prescription-free at-home coronavirus test. According to the press release, the test is instructed to be used by any individual two years of age or older, both with and without symptoms and costs about $30.

The test, developed by the Australian company Ellume, detects bits of coronavirus proteins called antigens. Despite the fact that antigen tests are less accurate than the PCR tests, a clinical study of nearly 200 people found that Ellume's test was able to correctly identify 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19," said FDA Commissioner Dr. Stephen M. Hahn. "By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.” 

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In mid-November, the FDA authorized the first at-home prescription coronavirus test from Lucira Health. Lucira's at-home coronavirus test is pricier, estimated at up to $50, can’t be used outside of a health care setting by children younger than 14 years of age and requires a prescription.

The news of the EUA for Ellume's product comes as the U.S. battles the worst of the pandemic so far. On Dec. 15, the country reported over 112,000 total current hospitalizations and nearly 3,000 daily deaths from the virus.

The fact that individuals — both symptomatic and asymptomatic — can quickly purchase and use Ellume's at-home coronavirus test will undoubtedly help to curb future outbreaks.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,"  said Dr. Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health. "However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic."

According to the press release from the FDA, the Ellume at-home coronavirus test "uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals through their smartphone."

The Australian company Ellume expects to produce more than three million at-home coronavirus tests in January 2021.


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UA COVID-19 Test Tracker

Daily (1/15)
1,226 23 %
Total (8/4)
124,667 3,598 %
Includes tests since August 4, 2020
Data from https://covid19.arizona.edu/updates
Updated January 15, 2021