QIAGEN Granted FDA EUA for Rapid Portable COVID-19 Test

QIAGEN 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 two 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 percent and a specificity of 98 percent.
 
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 eight 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.
 
QIAGEN N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in molecular diagnostics (human healthcare) and life sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2021, QIAGEN employed more than 5,900 people in over 35 locations worldwide.