OnSite™ Typhoid IgG/IgM Combo Rapid Test CE

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Specimen: S, P & WB

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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® Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of IgG and IgM antibodies against Salmonella typhi and paratyphi in human serum, plasma, or whole blood. By differentiating between IgG (past exposure/late stage) and IgM (early/acute stage), the test provides valuable insight into the stage of infection.

    This rapid test utilizes O and H antigens from both typhi and paratyphi serovars to maximize sensitivity. It is simple to use, requiring no equipment or complex sample preparation, and delivers results in 15 minutes, allowing healthcare providers to make timely clinical decisions.

    Key Features

    • Dual Detection: Differentiates IgG and IgM antibodies for infection staging.
    • Broad Antigen Coverage: Uses O and H antigens from S. typhi and S. paratyphi for improved sensitivity.
    • Rapid Results: Clear results available in 15 minutes.
    • Simple Workflow: One-step procedure reduces operator error.
    • Non-Invasive: Uses serum, plasma, or whole blood.
    • Reproducible & Reliable: High specificity and reproducibility.
    • Flexible Storage: Stable at 2–30 °C with 24-month shelf life.
    • No Equipment Needed: Ideal for point-of-care and field use.

    Clinical Performance

    • IgG Detection:
      • Sensitivity: 91.2% (95% CI: 76.3–98.1%)
      • Specificity: 99.0% (95% CI: 96.4–99.9%)
    • IgM Detection:
      • Sensitivity: 92.9% (95% CI: 66.1–99.8%)
      • Specificity: 99.0% (95% CI: 96.4–99.9%)

    Kit Contents (30 Tests)

    • Individually sealed foil pouches (cassette + desiccant)
    • Plastic droppers
    • Sample diluent (REF SB-R0161, 5 mL/bottle)
    • Instructions for use

    Applications

    • Clinical Diagnosis: Rapid detection of typhoid fever antibodies.
    • Point-of-Care Testing: Suitable for outpatient clinics, hospitals, and field use.
    • Public Health Programs: Epidemiological surveillance in endemic areas.
    • Resource-Limited Settings: Easy-to-use format requiring no laboratory equipment.


    The OnSite® Typhoid IgG/IgM Combo Rapid Test (R0161C) is a fast, reliable, and easy-to-use diagnostic tool for identifying antibodies against Salmonella typhi and paratyphi. By distinguishing between IgG and IgM responses, it enables clinicians to determine the stage of infection and guide patient management. With results in 15 minutes, high sensitivity and specificity, and simple storage requirements, this test is an excellent choice for clinical laboratories, hospitals, and public health programs.

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