Portable digital SARS-CoV-2 antigen test that can accurately analyze more than 30 samples per hour launched
QIAGEN announced it 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 two to 15 minutes.
A point-of-care (POC) claim will be added and emergency use authorization (EUA) will be 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 U.S. Food and Drug Administration (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.
Testing of clinical samples have shown the test to have a sensitivity of 90 percent and a specificity of 100 percent. It is the second QIAGEN COVID-19 test to make use of the digital eHub and eStick system made by its partner Ellume. QIAGEN in August announced the QIAreach Anti-SARS-CoV-2 Antibody Test – and both tests can run on the digital platform interchangeably.
The portable system provides a true walkaway solution with random access and does not require maintenance or calibration. It contains a rechargeable battery for eight hours of remote use and can fully connect to laboratory information management systems (LIMS) with an optional use software.
