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Elecsys® Dengue IgM
IVD
For in vitro diagnostic use.
Broaden your diagnostic window with reliable dengue IgM detection
Dengue virus continues to be a rising global threat, with tens of millions of cases reported annually and approximately 50% of the world's population currently at risk. Achieving an accurate diagnosis is critical for appropriate patient management and outbreak control. While NS1 antigen testing is most effective in the early acute phase (days 0–5), IgM antibodies typically become detectable 3–5 days after the onset of symptoms, peaking at two weeks and lasting for up to 3 months and beyond.1
The Elecsys® Dengue IgM assay is a fully automated immunoassay for the in vitro qualitative detection of IgM antibodies to the dengue virus in human serum and plasma. This mid- to high-throughput solution for the cobas® e 402 and cobas® e 801 analytical units delivers reliable results in just 18 minutes.2 By detecting IgM antibodies, the assay ensures reliable detection from early infection through the convalescent phase, providing a critical tool for clinicians to confidently manage patients.3
Ensure no patient is missed with combined Dengue Ag and IgM testing
Dengue diagnosis is time-sensitive. By combining the Elecsys® Dengue Ag (NS1) test with the Elecsys Dengue IgM assay, your laboratory can bridge the gap between early acute infection and the convalescent phase. This dual approach substantially improves diagnostic accuracy and ensures no patient is missed during the critical 3-10 day window.
Optimize dengue care with our new interactive clinical algorithm
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Elevate patient care with our interactive digital algorithm for clinicians. Simplify the diagnostic journey with WHO-aligned guidance on test timing (NS1, IgM, IgG, PCR) and expert result interpretation. Make informed clinical decisions from initial suspicion through follow-up with ease.
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Digital algorithm for clinicians
Ensure the best patient care with our new interactive digital algorithm. Designed for clinicians and HCPs, this cutting-edge tool simplifies the diagnostic journey.
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Overview
Product specifications |
Value |
Systems |
cobas e 402 and cobas e 801 analytical units |
Testing time |
18 minutes |
Test principle |
µ-capture |
Calibration |
2-point |
Interpretation |
COI < 1.0 non-reactive; COI ≥ 1.0 reactive. |
Specimen types |
Human serum and plasma (Li-heparin, K2-EDTA, K3-EDTA) |
Sample volume |
6 µL |
Onboard stability |
16 weeks |
Analytical specificity |
No cross-reactivity with WNV, YFV, or chikungunya virus infections. Cross-reactivity with Zika virus infections cannot be excluded. |
Technical documents
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Clinical sensitivity*
Clinical sensitivity*
Cohort |
N |
Reactive |
Sensitivity** (%) (95% CI) |
PCR-positive follow-up samples |
121 |
105 |
86.78% (79.42-92.25%) |
Relative specificity*
Relative specificity*
Cohort |
N |
Non-reactive |
Specificity *** (%) (95% CI) |
Donors from non-endemic region |
1,096 |
1,087 |
99.18% (98.45-99.62%) |
Donors from endemic region |
1,483 |
1,403 |
94.61% (93.33-95.70%) |
Overall |
2,579 |
2,490 |
96.55% (95.77-97.22%) |
** Clinical sensitivity was evaluated using 121 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 2,579 serum samples from healthy blood donors in both dengue-endemic (Colombia) and non-endemic (Austria) regions.
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References
- World Health Organization. Dengue and severe dengue [Internet; cited 2026 Feb 16]. Available from: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue.
- F. Hoffmann-La Roche Ltd. Elecsys® Dengue IgM Method Sheet. (v1.0). 2025-11.
- Devangi A, et al. The Combined Antigen and Antibody Testing Approach Improved the Sensitivity of Early Detection of Dengue Virus Infection. Research Journal of Pharmacy and Technology. 2025;18(4):1515-0.