Qiagen receives U.S. FDA EUA for SARS-CoV-2 antigen test

Aug. 12, 2021

Qiagen said it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach SARS CoV-2 Antigen Test.

The portable test can detect SARS-CoV-2 antigen in people with active infections in 2 to 15 minutes and can process an average of around 30 swab samples per hour. Qiagen said the test has a sensitivity of at least 80% and a specificity of 98.0%.

The company said the QIAreach SARS-CoV-2 Antigen Test is the second Qiagen COVID-19 test to make use of the digital eHub and eStick system that the company developed in partnership with Australian digital diagnostics company Ellume.

In May 2021, Qiagen received an EUA for its QIAreach Anti-SARS-CoV-2 Total Test that uses the same technology and eHub.

Qiagen’s UL-certified eHub is a portable reader with backup battery power able to be operated remotely from main power for up to 8 hours. The test has the capacity to analyze nasal and nasopharyngeal swab samples from up to eight symptomatic patients simultaneously. It uses nanoparticle fluorescent detection technology to flag the SARS-CoV-2 nucleocapsid protein, an antigen present on the surface of the virus. The device delivers negative results in 15 minutes — and in as little as two minutes in the case of a strong positive.

Visit Qiagen for more news