Covid-19 Home Test Receives Over-the-Counter Authorization

A box with the components of a new Covid-19 home test kit

Ellume’s Covid-19 home test offers a complete at-home sampling and testing solution. The single-use, Bluetooth-enabled test cartridge and self-collection swab are designed for consumer use in conjunction with a smartphone.

Photo: Ellume

The FDA recently granted emergency use authorization (EUA) for an innovative Covid-19 viral antigen test developed with technical support from NIH’s Rapid Acceleration of Diagnostics (RADx) Initiative, managed by NIBIB. Designed by Ellume, the rapid, at-home test is available without a prescription.

The first of its kind to be awarded EUA, the test is performed using a mid-turbinate nasal swab designed for comfortable self-sampling. The sample is inserted into a single-use cartridge that returns results in 15 minutes. The at-home test analyzer connects to the user’s smartphone through Bluetooth and pairs with a downloadable app that provides step-by-step instructions and displays results.

Users can share real-time results from the test—selling for approximately $30—with health care professionals, employers and schools for efficient Covid-19 tracking. Ellume plans to scale up manufacturing to deliver millions of home tests per month in 2021.