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16th December 2020  Product update: rapidmicrobiology staff writer

FDA Authorizes Over-the-Counter COVID-19 Home Test

Digital diagnostics company Ellume has announced its rapid, at-home COVID-19 antigen test has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The test will be available for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms and in adults and children aged 2 years and above. The Ellume COVID-19 Home Test is the first of its kind to be granted an EUA and provides an essential new tool to help combat the COVID-19 pandemic.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr Sean Parsons. “Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

The self-test works in conjunction with a free software application (app) downloaded on the user’s smartphone, which provides easy-to-read, step-by-step instructions including a how-to-use video.

All analysis is performed by the test’s electronic analyzer and using Bluetooth® connectivity, and the test result is displayed on the user’s smartphone in 15 minutes or less.

Clinical Performance
In data submitted to the FDA from an independently run, simulated home-setting clinical study of 198 subjects ranging in age from 2 years to 82 years, the Ellume COVID-19 Home Test demonstrated 96% accuracy, with an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test.

In individuals presenting with COVID-19 symptoms, the Ellume COVID-19 Home Test demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%.

The clinical study cohort was designed to be widely representative of ages and genders and spanned five testing locations in California, Texas, Alabama, Maryland and Louisiana.

A further independent analytical evaluation was conducted by Emory University, Georgia Institute of Technology, and Children’s Healthcare of Atlanta for the NIH RADx Tech program and determined that of the rapid antigen tests evaluated by the RADx Testing Core at the time, Ellume’s at-home COVID-19 antigen test demonstrated premium performance.

Core Technology
The Ellume COVID-19 Home Test’s core technology combines ultra-sensitive optics, electronics and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology.

The patented detection method detects minute fluorescence signals using unique fluorescent nanoparticles and a sophisticated reader system to achieve accurate results from a clinical sample, overcoming the sensitivity limitations of typical lateral flow technology.

The key elements of Ellume’s digital technology reduce the probability of false results, create new pathways to treatment, and optimize secure public health reporting. These unique features are critical to the approval, success and adoption of self-administered home testing.

How it works
The test includes a sterile Nasal Swab, a Dropper, Processing Fluid, and a Bluetooth® connected Analyzer for use with an app on the user’s smartphone. Utilizing the dedicated app, the user follows step-by-step video instructions to perform the test, including a self-collected mid-turbinate nasal swab.

The sample is analyzed, and results are automatically transmitted to the user’s smartphone via Bluetooth® in 15 minutes or less. Results can be shared with healthcare professionals to enable optimal therapy.

Through a secure cloud connection, Ellume’s COVID-19 Home Test can provide real-time reporting of test results to health authorities, employers, and educators, for efficient COVID-19 mapping.

Manufacturing Scale-Up
Ellume has been able to fast-track the development of its range of COVID-19 diagnostic tests with the support of a $30 million WP-2 grant from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative. 

To meet anticipated demand, Ellume has expanded its manufacturing facility in Brisbane, Australia, the largest of its kind in the Southern Hemisphere, and is rapidly expanding its manufacturing efforts and supply chain within the U.S. Production has already commenced and Ellume will be shipping over 100,000 tests per day from next month. Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.

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Date Published: 16th December 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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