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FDA Issues Emergency Use Authorization for Qiagen Rapid Antigen Test for COVID-19

NEW YORK – Qiagen said on Friday that its rapid portable antigen test developed with Ellume for detecting SARS-CoV-2 has received Emergency Use Authorization from the US Food and Drug Administration.

The QiaReach SARS-CoV-2 Antigen Test can detect the virus in individuals with active infections in two to 15 minutes and can be used with nasal and nasopharyngeal swab samples from as many as eight symptomatic patients simultaneously. It can process an average of about 30 swab samples per hour and has demonstrated a sensitivity of at least 80 percent and specificity of 98 percent in clinical studies, Qiagen said.

It is the second COVID-19 test that the company has developed in partnership with Australian diagnostics company Ellume that runs on the digital eHub and eStick system. In May a test co-developed by the two firms received EUA from the FDA. That test, called the Anti-SARS-CoV-2 Total Test, is for identifying individuals carrying antibodies against SARS-CoV-2 and also runs on the digital eHub and eStick system.

eHub is a portable reader with backup battery power that can be operated remotely from main power for up to eight hours, while eStick uses nanoparticle fluorescent detection technology to alert for the presence of the SARS-CoV-2 nucleocapsid protein, an antigen which is present on the surface of the virus.

"Knowledge of past and present infections is key to understanding and inhibiting the spread of the disease," said Jenny Howard, head of Qiagen's Immune Monitoring Franchise. "The QiaReach SARS-CoV-2 Antigen Test delivers rapid and highly accurate results and addresses the high-volume testing needs for SARS-CoV-2 antigens – and in combination with QiaReach Anti-SARS-CoV-2 Total Test allows labs to run antigen tests and antibody tests at the same time."