QIAGEN receives U.S. FDA Emergency Use Authorization for fast and easy-to-use digital test to detect SARS-CoV-2 coronavirus antibodies

QIAGEN has announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach^® Anti-SARS-CoV-2 Total Test.

The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.

The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%). QIAGEN’s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response – while most other tests currently identify only selected antibodies.

The QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume’s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.

Research into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.

“Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection,” said Davide Manissero, Chief Medical Officer of QIAGEN. “As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.”

Traditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach^® QuantiFERON^®-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.

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