Dengue IgG/IgM/NS1 Rapid Test – EZER™ Diagnostic Kit

What is in the Dengue Rapid Test?

The EZER™ Dengue IgG/IgM/NS1 Combo Rapid Test includes:

Kit Components:

• 20 Combo test devices

• 20 IgG/IgM droppers (10 μL)

• 20 NS1 droppers (30 μL)

• 1 vial of sample buffer

• 1 package insert

The test detects three diagnostic markers from a single patient specimen. NS1 antigen appears early (day 1–9), while IgM indicates recent infection and IgG suggests prior exposure or secondary infection.

This triple-marker capability makes it a powerful tool for comprehensive Dengue diagnostics.

Role of NS1, IgM, and IgG in Dengue Diagnosis

Dengue is caused by four serotypes of flaviviruses (DEN-1 to DEN-4), transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It presents with fever, rash, headache, and in severe cases, progresses to Dengue Hemorrhagic Fever (DHF) or Dengue Shock Syndrome (DSS).

Marker Profiles:

• NS1 antigen — Detectable from day 1 to 9 after symptom onset. Indicates early viral replication.

• IgM antibody — Typically detectable from day 4–5 onward; indicates primary infection.

• IgG antibody — Appears later (after ~7 days), often stronger in secondary infections.

This test’s ability to detect both antigen and antibodies ensures accurate identification of Dengue-positive cases at different stages of infection, aiding triage, quarantine, and treatment decisions.

About the EZER™ Dengue IgG/IgM/NS1 Combo Rapid Test Device

Produced by Genesis Biotech, the EZER™ Dengue rapid test demonstrates excellent diagnostic performance:

• NS1 Sensitivity: 97.4%

• NS1 Specificity: 100%

• IgM Agreement: 94.8%

• IgG Agreement: 100%

• Overall Accuracy: 99.4%

Detection Limits:

• IgG/IgM LOD: 1:128 antibody titer

• NS1 Antigen LOD: As low as 3.5×10⁻³ mg/mL depending on serotype

No cross-reactivity was observed with HCV, HIV, syphilis, adenovirus, influenza A/B, or RSV. The test remained unaffected by common interference substances like bilirubin, triglycerides, and hemoglobin.

Its built-in procedural control line ensures validity, making this Dengue-targeted assay both robust and dependable for field use or high-volume clinical settings.

Principle and Workflow

This is a qualitative, membrane-based lateral flow immunoassay. The cassette includes two wells:

• NS1 well: Detects antigen using gold-labeled mouse anti-Dengue NS1 antibodies.

• IgG/IgM well: Detects antibodies with Dengue antigen-coated particles and anti-human IgG/IgM lines.

Procedure:

1. Bring all components to room temperature

2. Apply:

   • 10 µL of sample + 2 drops buffer to IgG/IgM well

   • 30 µL of sample + 2 drops buffer to NS1 well

3. Wait 10 minutes

4. Read results visually (do not interpret after 20 minutes)

Result Interpretation:

• IgM Positive: Line at “M” (Primary infection)

• IgG Positive: Line at “G” (Secondary infection)

• NS1 Positive: Line in NS1 test zone (Acute infection)

• Dual Positive: IgG + IgM + NS1 lines

• Negative: Only control line visible

• Invalid: No control line — retest required

The triple-marker system ensures clarity for both early- and late-stage Dengue-positive infections.

Clinical Application

This test is ideal for:

• Hospitals and diagnostic labs identifying acute febrile illness

• Travel medicine clinics screening returning travelers

• Public health programs during regional Dengue outbreaks

• Tropical disease centers managing endemic area patients

Its triple-marker approach enables early detection, treatment stratification, and accurate surveillance across the disease course. By combining NS1, IgM, and IgG, the test offers clinical teams a full diagnostic picture with one sample and one cassette.

In environments lacking PCR or ELISA access, the EZER™ Dengue Rapid Test is an essential diagnostic tool.