> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Qiagen EUA for Rapid Covid Antigen Test
- URL: https://www.fdaweb.com/qiagen-eua-for-rapid-covid-antigen-test/
- Published: 2021-08-06T12:00:00.000Z
- Updated: 2026-09-14T17:09:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149885

FDA has granted Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around 30 swab samples per hour. Clinical studies show the test has sensitivity of at least 80% and specificity of 98.0%, according to the company. The test uses Qiagen’s UL-certified eHub, a portable reader with backup battery power that can be operated remotely for up to eight hours, the company says.

The test has the capacity to analyze nasal and nasopharyngeal swab samples from up to eight symptomatic patients simultaneously. It delivers negative results in 15 minutes, and can identify strong positive cases in under two minutes, Qiagen says.