Industry News: QIAGEN receives FDA authorization for rapid portable test that can analyze over 30 samples per hour for SARS-CoV-2 antigen

QIAreach SARS-CoV-2 Antigen Test, developed in collaboration with Ellume, provides accurate and objective results in 2 to 15 minutes

20 Aug 2021


QIAGEN has announced it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAreach® SARS CoV-2 Antigen Test, which is designed for environments that require a high volume of fast and accurate test results.

The rapid 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, providing digital test results that do not require subjective interpretation. Clinical studies have shown the test to have a sensitivity of at least 80% and a specificity of 98.0%.

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 was 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. Lab professionals will now be able to run tests to detect both previous and active infections on one device at the same time – with each testing slot operating independently of the others.

“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.”

The QIAreach SARS-CoV-2 Antigen Test uses QIAGEN’s UL-certified eHub, 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. The easy-to-use eStick 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. This means one eHub can process on average about 30 tests per hour with the possibility for one user to operate more than one eHub.

The QIAreach SARS-CoV-2 Antigen Test and the QIAreach SARS-CoV-2 Antibody Test run on the eHub platform that QIAGEN is using for QIAreach® QuantiFERON®-TB, a new solution still in development that will help low-resource and high-burden regions diagnose latent tuberculosis infection.

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