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CE-IVD Certified All-Stage Dengue Diagnostic Assay

Dengue IgG/IgM & NS1
Combo Rapid Test

Comprehensive multi-marker lateral flow chromatographic immunoassay for the simultaneous detection of Dengue virus NS1 antigen and differential IgG/IgM antibodies in human whole blood, serum, or plasma. Delivers full diagnostic window coverage from Day 1 through convalescence in 15 minutes.

Readout Time 15 Minutes
Specimen Type Blood / Serum / Plasma
Diagnostic Coverage Day 1 to Recovery
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid Dengue Trio Device CE-IVD Marked
NS1 Antigen
S
IgG / IgM Ab
S
C — Procedural Control
T — NS1 Early Antigen
G — IgG Secondary/Past
M — IgM Primary Acute
Comprehensive Arboviral Virology

All-Phase Triage for Acute Dengue Infection

Dengue virus presents a dynamic diagnostic challenge. NS1 antigen surges during early viremia (Days 1–5), IgM appears at Days 4–6 indicating primary infection, and IgG rises rapidly in secondary infection with heightened hemorrhagic shock risks.

Day 1 to 9 Detection

Early Acute Viremia (NS1)

Secreted viral non-structural protein 1 (NS1) allows immediate diagnostic confirmation on the first day of fever, long before serological seroconversion.

  • Detects all 4 Dengue serotypes (DENV 1–4)
  • Enables early hospital admission and platelet monitoring
  • Eliminates false-negative early serology delays
Clinical Staging

Primary vs. Secondary (IgG/IgM)

Differentiates acute primary infection from high-risk secondary infection linked to Dengue Hemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS).

  • IgM positive confirms acute primary illness
  • Early surging IgG indicates secondary infection risk
  • Vital for clinical triage and fluid management
Travel Medicine

Returning Traveler Screening

Essential for travel clinics, infectious disease units, and emergency departments across Dubai and the UAE evaluating acute febrile returning travelers.

  • Frontline tool for endemic zone returnees
  • Zero cross-reactivity with Zika or Chikungunya
  • Same-day dispatch across Dubai & Abu Dhabi

Analytical & Clinical Validation Data

Multi-Center Clinical Evaluation vs. RT-PCR & Commercial ELISA
Diagnostic Marker Clinical Sensitivity Clinical Specificity Reference Method
Dengue NS1 Antigen 96.5% (92.8% – 98.7%) 99.1% (97.4% – 99.8%) RT-PCR Reference
Dengue IgM Antibody 95.8% (91.5% – 98.3%) 98.8% (96.8% – 99.7%) Commercial MAC-ELISA
Dengue IgG Antibody 96.2% (92.1% – 98.5%) 98.5% (96.4% – 99.5%) Commercial IgG ELISA
Combined Diagnostic Accuracy 98.9% Overall Agreement Zero Cross-Reactivity Zika, Chikungunya, Yellow Fever, Malaria
Limit of Detection (LoD) 0.25 ng/mL (NS1) 1:100 titer (IgM/IgG) All 4 Serotypes (DENV 1–4)
*Clinical Note: In secondary dengue infections, NS1 sensitivity remains high while IgM may be attenuated and IgG titers surge rapidly. The 3-marker combination ensures 100% window capture.
Standard Operating Procedure

4-Step Rapid Diagnostic Protocol

Standardized testing protocol for whole blood, serum, or plasma specimens across both test channels.

1

Blood Harvesting

Clean fingertip with alcohol pad and lance to produce a free-flowing blood drop, or draw venous whole blood into an EDTA or plain collection tube.

2

NS1 Well Loading

Using the calibrated dropper, transfer 3 drops of whole blood (approx. 75 µL) or 2 drops of serum/plasma directly into the NS1 sample well (S).

3

Ab Well Loading

Transfer 1 drop of specimen (approx. 10 µL) into the IgG/IgM sample well (S), followed immediately by 2 drops of assay buffer.

4

15-Min Readout

Start timer. Read visual results in both test windows at 15 minutes. Strongly positive lines appear early; confirm negatives at full 15 minutes.

Result Interpretation Guide

Comprehensive Clinical Interpretation Matrix

Evaluate colorimetric lines across both the NS1 and Antibody windows.

Diagnostic Result Patterns

Correlate lines in NS1 (T) and Antibody (M, G) windows.

NS1 Positive Only
Bands at NS1-C and NS1-T. Indicates early acute viremia (Days 1–4 of fever).
NS1 + IgM Positive
Bands at NS1-T and Ab-M. Indicates acute primary dengue at peak diagnostic transition (Days 4–7).
IgG Positive (With or Without NS1)
Band at Ab-G. Indicates secondary dengue infection or past immunity; monitor for plasma leakage.
Completely Negative
Only Control lines (C) in both windows. No T, M, or G bands observed.
Invalid Test
Either Control line (C) fails to appear. Discard cassette and repeat test.

Clinical Action Protocols

Evidence-based clinical triage pathways.

Early Viremia Care
NS1 positivity mandates serial complete blood counts (CBC) to monitor hematocrit and platelet counts daily.
Secondary Infection Alert
Secondary dengue carries elevated risk of severe capillary leak syndrome; evaluate for warning signs and hospital admission.
Differential Diagnosis
In febrile travelers with negative dengue results, pair with QuRapid Malaria Pf/Pan Rapid Test to rule out co-endemic malaria.
Packaging Configuration

Everything Required for 25 Determinations

Each kit is packaged with all consumables necessary for POC multi-marker testing.

💾
25 Combo Cassettes Individually sealed in foil pouches with desiccant
🧪
Assay Buffer Dropper Bottle Pre-standardized running buffer for 25 determinations
🧸
25 Capillary Pipettes Calibrated specimen transfer droppers
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Instructions for Use Illustrated SOP protocol and multi-marker interpretation guide
Clinical Support

Frequently Asked Questions

Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our infectious disease specialists in Dubai.

Contact Clinical Specialist
Why is combining NS1 antigen and IgG/IgM antibodies diagnostically necessary?

Standalone NS1 misses cases presenting late (>Day 7), while antibody tests miss acute early infection (Days 1 to 3). Combining NS1, IgM, and IgG provides 100% window coverage throughout the entire illness.

Does this combo test detect all 4 Dengue serotypes?

Yes. High-affinity monoclonal antibodies specifically capture conserved hexameric NS1 epitopes across DENV-1, DENV-2, DENV-3, and DENV-4.

Can fingerstick capillary blood be tested directly?

Yes. The assay is fully validated for capillary fingerstick whole blood, venous whole blood, serum, and EDTA or heparinized plasma.

What packaging configuration is provided?

Each box contains 25 individually sealed dual-window cassettes, 25 capillary transfer droppers, 1 dropper bottle of assay buffer, and the package insert.

How can healthcare centers in the UAE order wholesale supplies?

QuRapid provides same-day dispatch across Dubai, Abu Dhabi, and Northern Emirates hospitals, clinics, and laboratories with complete regulatory documentation.

Equip Your Clinic With QuRapid Dengue Trio Combo Rapid Tests

Order CE-IVD certified Dengue IgG/IgM & NS1 Combo Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for fever triage centers, travel clinics, and diagnostic laboratories.

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