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

Roche announced that it has received CE mark for its Elecsys Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the diagnosis of an acute dengue virus infection. This milestone promises to set a new standard for efficiency and reliability in tackling the growing global challenge of dengue fever.

Recognising the value of diagnostics, the WHO has developed an “Essential Diagnostics List” which includes in-vitro diagnostic solutions that should be accessible to all countries to increase timely and life-saving diagnoses. Dengue virus NS1 antigen, along with other biomarkers, is included in the WHO essential IVD list.

“Dengue’s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources,” said Matt Sause, CEO of Roche Diagnostics. “Roche is committed to supporting the global response to the rise of infectious diseases such as dengue. With our novel Elecsys Dengue antigen test, we enable healthcare systems to diagnose dengue more reliably and efficiently.”

The Elecsys Dengue Ag is an in-vitro diagnostic immunoassay for the qualitative detection of the NS1 antigen of the dengue virus in human serum and plasma, a key marker of acute infection during the first days of illness. It is intended for use on Roche’s fully automated cobas e immunoassay analysers: cobas e 801 systems and cobas e 402 platforms – a widely used platform with an extensive installed base in labs worldwide.

The test has been shown to reliably detect NS1 antigen for all four dengue virus serotypes – DENV-1, DENV-2, DENV-3, and DENV-4. In clinical studies, it demonstrated 94.90% (CI: 91.44–97.26%) sensitivity in PCR-confirmed positive samples and 99.96% (CI: 99.79–100%) relative specificity in a large cohort of healthy blood donors.

Key benefits of the Elecsys Dengue Ag test include:

Reliable and Fast Results: The Elecsys Dengue Ag test has a turnaround time of 18 minutes. It is designed for use on Roche’s automated cobas e immunoassay analyzers with a throughput from 120 to up to 300 tests/hour. This ensures reliable results for effective patient management during outbreaks and supports surveillance efforts in both endemic and non-endemic settings.

Enhanced Efficiency and Traceability: The automated nature of the Elecsys and cobas instruments improves lab consolidation, workflow, and traceability, reducing manual activities and the potential for human error.

Comprehensive response across the entire patient journey: The Elecsys Dengue Panel, which includes the Elecsys Dengue Ag test, alongside the Elecsys Dengue IgM test and Elecsys Dengue IgG test that will be subsequently launched, is designed to cover all key serological biomarkers for dengue diagnosis. By addressing NS1 for acute infection, IgM for recent exposure, and IgG for long-term immunity, the panel equips clinicians with the tools to diagnose dengue accurately at every stage of the disease.