Early and reliable dengue detection for confident patient management

Dengue is the most prevalent mosquito-borne viral disease, representing a significant and rapidly spreading global health challenge. Early and accurate diagnosis is critical for initiating appropriate patient management, which can significantly lower fatality rates, and for enabling effective surveillance to control potential outbreaks.¹ Since the initial symptoms of dengue are often non-specific, distinguishing it from other febrile illnesses is a critical diagnostic challenge.

The Elecsys® Dengue Ag assay is a fully automated immunoassay for the in vitro qualitative detection of the dengue virus non-structural protein 1 (NS1) antigen in human serum and plasma. The detection of the NS1 antigen, which is released from infected cells during the acute phase of the infection, is a valuable method for the early diagnosis of a dengue virus infection. This state-of-the-art solution delivers reliable results in just 18 minutes, providing a critical tool to help clinicians confidently manage patients and support public health efforts against this widespread disease.²

Benefits at a glance

Fast and efficient results to support timely clinical decisions

With a rapid reaction time of 18 minutes, the Elecsys Dengue Ag assay delivers fast, actionable results. As a fully automated solution for the cobas® e 402 and cobas® e 801 analytical units, the assay integrates seamlessly into the laboratory workflow, improving efficiency and traceability while reducing manual activities.

High clinical performance for diagnostic confidence

The Elecsys Dengue Ag assay provides results you can trust:

High Sensitivity: The assay demonstrated a clinical sensitivity of 94.90% in a study of 255 PCR-confirmed positive samples from diverse geographic regions²
Excellent Specificity: In a study of 2,596 healthy blood donors from both endemic and non-endemic regions, the assay showed an overall relative specificity of 99.96%²
No Cross-Reactivity: No cross-reactivity was observed with other clinically relevant flaviviruses, including Zika virus, West Nile virus, Yellow Fever virus, and Japanese Encephalitis virus²

Broad serotype coverage with a small sample volume

The Elecsys Dengue Ag assay uses monoclonal antibodies to detect the NS1 protein from all four distinct dengue virus serotypes (DENV1-DENV4). The assay requires a small sample volume of just 18 µL.

Elecsys Dengue Ag clinical performance

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Clinical sensitivity*

Cohort	N	Reactive	Sensitivity (95% CI)**
PCR-positive samples	255	242	94.90% (91.44-97.26%)

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Relative specificity*

Cohort	N	Non-reactive	Specificity* (95% CI)**
Donors from non-endemic region	1,099	1,098	99.91% (99.49-100.0%)
Donors from endemic region	1,497	1,497	100.0% (99.75-100.0%)
Overall	2,596	2,595	99.96% (99.79-100.0%)

* F. Hoffmann-La Roche Ltd. Elecsys^® Dengue Ag method sheet. (v1.0). 2025.
** Clinical sensitivity was evaluated using 255 serum and/or plasma samples from patients with a dengue infection confirmed by a PCR assay. The samples were collected from diverse regions, including Africa, Europe, the Caribbean, and Latin America.
*** Relative specificity was evaluated using 2,596 serum samples from healthy blood donors in both dengue-endemic (Colombia) and non-endemic (Austria) regions.

Elecsys Dengue Ag specifications

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Product specification	Value
Systems	cobas e 402 and cobas e 801 analytical units
Testing time	18 minutes
Test principle	One-step double antibody sandwich assay
Calibration	2-point
Interpretation	COI <1.0 = non-reactive, COI ≥1 = reactive
Specimen types	Human serum and plasma (Li-heparin, K2-EDTA, K3-EDTA)
Sample volume	18 µL
Onboard stability	16 weeks

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Elecsys^® Dengue Ag

Early and reliable dengue detection for confident patient management

Benefits at a glance

Elecsys Dengue Ag clinical performance