Roche Wins CE Mark for Elecsys Dengue Ag Diagnostic Test

Roche announced that it has acquired the CE mark for Elecsys Dengue Ag, their high-throughput, fully-automated immunoassay system that helps the diagnosis of acute dengue virus infections.

Dengue fever is still the most common mosquito-borne viral disease in the world, and 2024 is the year of a new record - more than 14.6 million cases have been reported and over 12,000 people have died in more than 100 countries. As half of the world's population is living in the dengue-endemic areas, the need for timely and accurate diagnosis has become a very important global health issue.

The Elecsys Dengue Ag test is an immunoassay for in vitro diagnostics that identifies the NS1 antigen - a very important marker for the acute phase of infection when the first days of the disease are the only ones where this antigen is present.

The test is done on Roche's fully automated cobas e immunoassay analyzers, like the cobas e 801 and cobas e 402 systems - the machines that are used in clinical laboratories all over the world.

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The test is valid for all four serotypes of the dengue virus i.e. the DENV-1 to DENV-4, and in clinical trials, it showed 94.9% sensitivity and 99.96% specificity, thus providing early and reliable diagnosis.

“Dengue's quick spread around the world has made the situation very difficult for health systems,” Matt Sause, CEO of Roche Diagnostics, said. “Our aim with the Elecsys Dengue antigen test is to give the healthcare professionals more powerful diagnostic tools that are faster and more accurate and in turn, patient outcomes can be improved.”