Roche has received CE Mark approval for its Elecsys Dengue Ag test, a high-throughput, fully automated immunoassay designed to aid in the diagnosis of acute dengue virus infection. This milestone represents a significant advancement in efficiency and reliability for laboratories worldwide, helping healthcare systems address the escalating global dengue crisis.

Dengue fever remains the most widespread mosquito-borne viral infection globally. In 2024, the world recorded the highest number of dengue cases ever within a single year — over 14.6 million infections and more than 12,000 deaths across more than 100 countries. As half of the global population now lives in areas at risk, the need for early and accurate diagnosis has become more urgent than ever.

Because dengue symptoms often resemble other febrile illnesses such as chikungunya or yellow fever, timely diagnosis is crucial for effective patient management and preventing severe complications.

“Dengue’s rapid worldwide spread has made it a major public health burden, placing immense strain on healthcare systems,” said Matt Sause, CEO of Roche Diagnostics. “Roche is dedicated to supporting the global response to infectious diseases like dengue. With our innovative Elecsys Dengue antigen test, we empower healthcare systems to diagnose the disease with greater reliability and efficiency.”

The World Health Organization (WHO) includes dengue virus NS1 antigen among the biomarkers on its Essential Diagnostics List, underscoring the importance of accessible in-vitro diagnostics for timely, life-saving care.

The Elecsys Dengue Ag test is an in-vitro diagnostic immunoassay that qualitatively detects the NS1 antigen — a key marker of acute dengue infection — in human serum or plasma. It is intended for use on Roche’s fully automated cobas e immunoassay analysers, including the cobas e 801 and cobas e 402 platforms, which are widely used in laboratories across the globe.

Clinical studies demonstrated the test’s strong performance, showing 94.9% sensitivity in PCR-confirmed dengue-positive samples and 99.96% specificity in healthy donor samples. It reliably detects all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).