Last week the FDA granted approval under EUA for a diagnostic kit - A Lateral Flow Antigen test - made by Ellume, a digital diagnostic company. Company media announcement states -
With core technology developed over ten years, Ellume’s COVID-19 Home Test combines ground-breaking technology with world-class usability to offer best-in-class at-home digital diagnostics. 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, 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%.
Core Technology -
Supercharged fluorescent immunochromatography using a quantum-dot based fluorescent particle
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.
How it works
Safe, accurate and rapid self-test
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.
This test uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) and can be used over the age of 2 years.
The test kit is expected to be sold around 30.00 USD , a bit too expensive for a home diagnostic kit I believe.
With core technology developed over ten years, Ellume’s COVID-19 Home Test combines ground-breaking technology with world-class usability to offer best-in-class at-home digital diagnostics. 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, 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%.
Core Technology -
Supercharged fluorescent immunochromatography using a quantum-dot based fluorescent particle
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.
How it works
Safe, accurate and rapid self-test
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.
This test uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) and can be used over the age of 2 years.
The test kit is expected to be sold around 30.00 USD , a bit too expensive for a home diagnostic kit I believe.
