Dengue fever

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

Strategic Insights

Oct 29, 2025 — 1 min read

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

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