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OnSite™ Leptospira IgG/IgM Combo Rapid Test
Catalog No :
CAS Number :
Brand :
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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 Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay designed for the qualitative detection and differentiation of IgG and IgM antibodies to Leptospira interrogans in human serum, plasma, or whole blood.
The test can be performed by minimally skilled personnel within 15–20 minutes and does not require laboratory equipment. It is intended for professional use as a screening tool, providing preliminary results to aid in the diagnosis of acute or past leptospira infection, in conjunction with clinical evaluation.
Recommended Use
- Patients with clinical signs and symptoms of leptospira infection (e.g., high fever, chills, headache, muscle aches, jaundice, red eyes, diarrhea, vomiting, skin rash).
- Individuals exposed to a known contaminated source.
Key Features
- Rapid & simple – results in 15–20 minutes.
- Differentiates IgG and IgM antibodies – supports staging of infection.
- High accuracy – 100% sensitivity and 100% specificity (vs. reference rapid test).
- Cross-reactivity free – no false positives observed with TP, HIV, Dengue, TB, Typhoid, HBsAg, HCV, HEV, HAV, H. pylori, HCG, RF, ANA, or HAMA specimens.
- No interference – validated against common interfering substances including salicylic acid, glucose, sodium citrate, heparin, creatinine, bilirubin, EDTA, hemoglobin, human IgG, and albumin.
- Shelf life – 24 months from manufacturing date.
Kit Contents (30 Tests, Cat. No. R0101C)
- 30 × Individually sealed test cassettes with desiccant.
- 5 μL capillary tubes.
- 1 × Sample diluent (REF SB-R0101, 5 mL/bottle).
- Package insert (instructions for use).
Product Specifications
| Property | Value |
|---|---|
| Catalog Number | R0101C |
| Product | Leptospira IgG/IgM Combo Rapid Test |
| Quantity | 30 tests/kit |
| Specimen Type | Serum, Plasma, Whole Blood |
| Test Type | Lateral flow chromatographic immunoassay |
| Accuracy | 100% sensitivity & 100% specificity |
| Result Time | 15–20 minutes |
| Shelf Life | 24 months |
| Storage | Room temperature (as per IFU) |
The OnSite Leptospira IgG/IgM Combo Rapid Test (R0101C) is a reliable, accurate, and easy-to-use rapid diagnostic tool for screening leptospira infections. With high sensitivity, specificity, and no observed cross-reactivity or interference, it is ideal for clinical settings, outbreak investigations, and healthcare facilities requiring quick results.