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Dengue fever

Roche Receives CE Mark for Elecsys Dengue Ag Test, a High-Throughput Antigen Assay for Dengue Diagnosis

Strategic Insights

— 2 min read

Roche has announced the receipt of CE mark for its Elecsys(R) Dengue Ag test, a high-throughput, fully automated immunoassay for the diagnosis of acute dengue virus infection. The test has demonstrated high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, enabling clinicians to confidently distinguish dengue from other acute fever-causing illnesses.

The Elecsys Dengue Ag test is designed to be used on Roche's automated cobas e immunoassay analyzers, which can perform up to 300 tests per hour, providing reliable results in just 18 minutes. This enables faster laboratory workflows and patient management during outbreaks. The test has also been shown to enhance efficiency and traceability in laboratories, reducing manual activities and the potential for human error.

The global incidence of dengue is rising sharply due to climate change, putting nearly half the world's population at risk. Children, the elderly, individuals with weakened immune systems, and those with underlying conditions are at higher risk of developing severe dengue. Close monitoring and fluid management are crucial to prevent severe complications.

Key Takeaways:

  • The Elecsys(R) Dengue Ag test has received CE mark for the diagnosis of acute dengue virus infection.
  • The test demonstrates high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes.
  • The test is designed for use on Roche's automated cobas e immunoassay analyzers, which can perform up to 300 tests per hour.
  • The test provides reliable results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks.
  • The test has been shown to enhance efficiency and traceability in laboratories, reducing manual activities and the potential for human error.
  • Roche is committed to supporting the global response to the rise of infectious diseases such as dengue.
  • The World Health Organization (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.

Statistics:

  • Over 100 countries on all continents were affected by dengue in 2024.
  • The global incidence of dengue has risen sharply, with over 14.6 million cases and more than 12,000 dengue-related deaths in 2024.
  • Half of the world's population now lives in areas at risk of dengue infection.
  • The Elecsys Dengue Ag test has a turnaround time of 18 minutes.
  • The test can perform up to 300 tests per hour on Roche's automated cobas e immunoassay analyzers.

Sources:

  • World Health Organization, Dengue Factsheet, August 2025, available at URL: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
  • Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
  • WHO Model List of Essential In Vitro Diagnostics, September 2025, available at URL: https://edl.who-healthtechnologies.org/
  • Elecsys(R) Dengue Ag method sheet, V1.0 2025-06.

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