Ellume Health’s rapid at home COVID-19 antigen test has demonstrated 96% accuracy compared to an Emergency Use Authorization molecular test in an independently run clinical study of 198 patients.
The Brisbane, Australia-based company said it has now submitted EUA to FDA for the rapid self-test enables individuals to test for an active COVID-19 infection in 15 minutes or less.
Data submitted to FDA from the clinical study shows Ellume’s COVID-19 home test demonstrated an overall sensitivity of 95% and specificity of 97% 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%
Ellume’s 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 swab. The sample is analyzed, and results are automatically transmitted to the user’s smartphone via Bluetooth in 15 minutes or less.
COVID-19 tests have been evolving in specificity since the first batch of diagnostics received EUA in February. There has also been the emergence of the take-home test market.
Last month, Lucira Health won EUA for a take-home COVID-19 test. The Emeryville, CA-based company said its test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
Abbott Laboratories changed the paradigm for COVID-19 tests in late August when it gained EUA for a $5, 15-minute diagnostic for the virus.