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OnSite™ Rubella IgG/IgM Rapid Test Kit, 30 Tests
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Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite Rubella IgG/IgM Rapid Test CE is a lateral flow chromatographic immunoassay for the semi-quantitative detection and differentiation of IgG and IgM antibodies to the rubella virus in human serum, plasma, or whole blood. This CE-marked test facilitates differentiation between past exposure, current infection, and susceptibility to rubella virus, which is critical for prenatal risk assessment, obstetric care, and outbreak control.
The test is standardized to the WHO 1st International Standard for anti-rubella immunoglobulin (RUBI-1-94) and provides rapid, cost-effective results in just 10 minutes with a 4-line detection format that simultaneously identifies IgM and IgG antibody levels.
Key Features
- Differentiates between high (≥250 IU/mL) and low (15–250 IU/mL) IgG levels.
- Detects and differentiates IgG and IgM anti-rubella virus antibodies.
- Supports prenatal screening and outbreak management.
- WHO-standardized for consistent results (RUBI-1-94).
- High correlation with ELISA results on BBI Mixed Titer Panel PTR-201.
- Rapid results in 10 minutes for same-visit decision-making.
- 4-line format allows simultaneous IgM and IgG detection, saving time and cost.
- Suitable for serum, plasma, and whole blood samples.
Kit Contents
Each kit (30 tests) contains:
- One cassette device (per pouch).
- One desiccant.
- Capillary tubes (10 µL).
- Sample diluent (REF SB-R0243, 5 mL/bottle).
- Package insert (instructions for use).
Specifications
| Parameter | Details |
|---|---|
| Product Name | Rubella IgG/IgM Rapid Test CE |
| Catalog Number | R0243C |
| Format | 30 tests/kit |
| Specimen Type | Serum (S), Plasma (P), Whole Blood (WB) |
| Detection | IgG and IgM antibodies to rubella virus |
| Differentiation | High (≥250 IU/mL) vs. Low (15–250 IU/mL) IgG levels |
| Principle | Lateral Flow Chromatographic Immunoassay |
| Sample Volume | 10 µL |
| Turnaround Time | 10 minutes |
| Standardization | WHO 1st International Standard RUBI-1-94 |
| Performance | High correlation with ELISA results (BBI PTR-201) |
| Regulatory Status | CE-marked |
Applications
- Prenatal screening for rubella susceptibility and immunity.
- Obstetric and symptomatic patient screening.
- Rapid outbreak control during rubella epidemics.
- Public health monitoring of rubella immunization programs.
- Laboratory and point-of-care testing in clinical settings.
The OnSite Rubella IgG/IgM Rapid Test CE provides a fast, accurate, and semi-quantitative solution for rubella antibody detection and differentiation. With WHO-standardized calibration, dual IgG/IgM detection, and rapid 10-minute results, this CE-marked test supports prenatal risk assessment, outbreak control, and clinical decision-making. Its ease of use, strong ELISA correlation, and reliable performance make it a trusted tool for hospitals, laboratories, and public health programs worldwide.