The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Ellume COVID-19 Home Test, the first over-the-counter (OTC) fully at-home diagnostic antigen test for coronavirus disease 2019 (COVID-19).

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Initiative. The test is designed to detect active COVID-19 in individuals aged 2 years and older with or without symptoms. It detects minute fluorescence signals using fluorescent nanoparticles and a reader system.

The test includes a sterile mid-turbinate nasal swab, a dropper, processing fluid, and a Bluetooth® -connected analyzer for use with an app on a smartphone; step-by-step video instructions on the app aid the user in performing the test. Real-time test results are then transmitted to the user’s smartphone in less than 15 minutes and can be shared with health care professionals, employers and schools.

The authorization was based on data from a simulated home-setting clinical study which included 198 individuals aged 2 to 82 years. Findings showed that the Ellume COVID-19 Home Test achieved 96% accuracy, with an overall sensitivity of 95% (positive percent agreement) and a specificity of 97% (negative percent agreement) when compared to an emergency use authorized RT-PCR laboratory test.


Continue Reading

Moreover, among individuals presenting with symptoms, the test demonstrated a sensitivity of 96% and specificity of 100%; among individuals without symptoms, the test demonstrated a sensitivity of 91% and specificity of 96%.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. 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,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. 

Additionally, the FDA noted that there is a small percentage of positive and negative results that may be false with this test. Positive results in asymptomatic individuals should be treated as presumptively positive until confirmed by another test as soon as possible.

Ellume COVID-19 Home Test is approximately $30 and the Company expects to produce more than 3 million tests in January 2021.

For more information visit fda.gov.

References

1.    Coronavirus (COVID-19) update: FDA authorizes antigen test as first over-the-counter fully at-home diagnostic test for COVID-19. [press release]. Silver Spring, MD: U.S. Food and Drug Administration; December 15, 2020. 

2.    FDA authorizes Ellume COVID-19 Home Test as first over-the-counter fully at-home diagnostic test. [press release]. Valencia, CA and Brisbane, Australia: Ellume; December 15, 2020