QIAGEN has 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, the company said in a press release.
The QIAreach SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, processes more than 30 swab samples per hour, provides digital test results that do not require subjective interpretation, and allows 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 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 has shown the QIAreach SARS-CoV-2 Antigen Test to have a sensitivity of 90 percent and a specificity of 100 percent, the company said. 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.
The portable system 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.
