Ellume
The FDA granted emergency use authorization for Ellume’s COVID-19 Home at-home over-the-counter test on Dec. 15.
Ellume COVID-19 Home is a fully at-home test that doesn’t need a prescription. The test includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth-connected analyzer for use with an app on a smartphone. The app gives users video instructions to perform the test and results show up on the accompanying smartphone app in less than 15 minutes. It’s possible to share results with healthcare providers, health authorities, employers and educators.
A simulated home-use clinical study of 198 subjects, ages 2 to 82, found Ellume’s test had 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, according to Ellume.
