Combo rapid test simultaneously detecting dengue NS1 antigen and IgG/IgM antibodies; distinguishes primary vs secondary infection. Professional use.
| Regulatory Class | IVD Medical Device (MDA) |
|---|
Product Overview
The RVR Dengue Combo NS1 & IgG/IgM Rapid Test is a lateral-flow immunoassay for simultaneous detection and differentiation of dengue NS1 antigen and IgG/IgM antibodies in serum, plasma or whole blood — enabling early and later-stage detection and presumptive distinction between primary and secondary infection.
Unique Selling Points
- Detects NS1 antigen and IgG/IgM antibodies in one test
- Differentiates primary vs secondary dengue infection
- Covers early (NS1) and later (antibody) infection windows
- No special equipment required
- High recurring demand in an endemic market
Directions for Use
- Bring specimen and components to room temperature.
- Add the specified specimen volume: use the dropper for NS1 and the capillary tube for IgG/IgM per the IFU.
- Add buffer as directed.
- Read results within 15–20 minutes (positives may appear from 5–10 min).
Specifications
| Targets | Dengue NS1 Ag + IgG/IgM |
|---|---|
| Specimen | Serum / plasma / whole blood |
| Sensitivity/Specificity (IgG/IgM) | 96.72% / 97.58% |
| Result time | 15–20 minutes |
| Intended use | Professional IVD |
| Storage | 4–30°C, do not freeze |
