Roche Receives CE Mark for Novel Automated High-Throughput Dengue Test

Strategic Insights -

Roche has made a breakthrough in the fight against dengue fever with the release of its novel automated high-throughput Elecsys Dengue Ag test. This cutting-edge diagnostic tool is designed to identify the dengue virus with unprecedented accuracy and speed, providing clinicians with a vital aid in distinguishing dengue from other acute fever-causing illnesses. The test's full automation and medium to high throughput capabilities enable lab efficiency and test traceability while minimizing the risk of human error.

Key Takeaways:

  • The Elecsys Dengue Ag test is a high-throughput, fully automated immunoassay that detects the NS1 antigen of the dengue virus in human serum and plasma.
  • The test has a turnaround time of 18 minutes and can process up to 300 tests per hour, ensuring reliable results for effective patient management during outbreaks.
  • The automated test reduces manual activities and the potential for human error, improving laboratory consolidation, workflow, and traceability.
  • The test is designed to address all key serological biomarkers for dengue diagnosis, including NS1, IgM, and IgG, making it a comprehensive tool for clinicians.
  • The World Health Organization (WHO) has included dengue virus NS1 antigen in its Essential Diagnostics List, which aims to increase timely and life-saving diagnoses.

Statistics:

  • In 2024, over 14.6 million cases of dengue were recorded, with more than 12,000 dengue-related deaths.
  • The global incidence of dengue is rising sharply due to climate change, putting nearly half the world's population at risk.
  • The Elecsys Dengue Ag test has demonstrated 94.90% sensitivity in PCR-confirmed positive samples and 99.96% relative specificity in a large cohort of healthy blood donors.

Sources:

  • M2 PressWIRE, October 30, 2025
  • World Health Organization, Dengue Factsheet, August 2025
  • Phillips ML. Dengue reborn: widespread resurgence of a resilient vector. Environ Health Perspect. 2008 Sep;116(9):A382-8. doi: 10.1289/ehp.116-a382. PMID: 18795135; PMCID: PMC2535648.
  • WHO Model List of Essential In Vitro Diagnostics, September 2025
  • Elecsys[R] Dengue Ag method sheet, V1.0 2025-06