QIAGEN has recently started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.

The QIAreach SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.

QIAGEN has begun marketing and distributing QIAreach SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.

“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN.

He added, “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”