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NIH Record - National Institutes of Health

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.

The NIH Record

The NIH Record, founded in 1949, is the biweekly newsletter for employees of the National Institutes of Health.

Published 25 times each year, it comes out on payday Fridays.

Associate Editor: Carla Garnett

Staff Writers:

Eric Bock

Dana Talesnik

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