Roche receives CE mark for novel automated high-throughput Elecsys Dengue Ag test to diagnose dengue

Roche has received CE mark approval for its Elecsys® Dengue Ag test, a fully automated immunoassay for diagnosing acute dengue infections. Dengue fever is a growing global health threat with rising cases straining healthcare resources. Accurate diagnosis is crucial because dengue symptoms are similar to other fever-causing illnesses, impacting patient management. The Elecsys Dengue Ag test detects the NS1 antigen, a key marker of acute infection, for all four dengue virus serotypes. Clinical studies showed high sensitivity (94.90%) and specificity (99.96%) of the test. It delivers results in 18 minutes on Roche's cobas® e immunoassay analyzers, enhancing lab efficiency. Automation improves workflow, traceability, and reduces manual errors, and test throughput runs from 120 to 300 tests/hour. The WHO includes dengue virus NS1 antigen in its Essential Diagnostics List and Roche is committed to combating infectious diseases. The Elecsys Dengue panel will offer a comprehensive approach with additional tests for IgM and IgG antibodies, covering all stages of dengue diagnosis.