CTK Biotech OnSite® TB IgG/IgM Combo Rapid Test Kit CE

Rapid Immunodiagnostic Test for Tuberculosis Antibody Detection

The OnSite TB IgG/IgM Combo Rapid Test CE is a lateral flow chromatographic immunoassay designed for the simultaneous qualitative detection and differentiation of IgM and IgG antibodies against Mycobacterium tuberculosis (M. TB) in human serum, plasma, or whole blood.

This rapid test is ideal for identifying both recent and past exposure to tuberculosis (TB), providing critical support in TB control and surveillance programs in clinical, field, and point-of-care settings.

Key Features

• Dual Antibody Detection: Simultaneously detects IgM (indicative of recent infection) and IgG (indicative of past exposure) anti-M. tuberculosis antibodies.
• Rapid Results: Results available within 10–15 minutes.
• Convenient Specimen Compatibility: Suitable for serum (S), plasma (P), or whole blood (WB).
• Easy-to-Use Format: Cassette-based test with simple dropper and buffer system; no need for instrumentation.
• CE Marked: Conforms to European regulatory standards for performance and safety.

Kit Components

Each test kit is individually packaged and contains:

• 1 x Test Cassette (foil pouch with desiccant)
• 1 x Sample Dropper
• 1 x Bottle of Sample Diluent (REF SB-R0053, 5 mL)
• 1 x Instruction for Use (Package Insert)

Technical Specifications

Applications

• TB screening in hospitals, clinics, and laboratories
• Field diagnostics in endemic areas
• TB surveillance and research studies
• Supportive testing in high-risk populations

The TB IgG/IgM Combo Rapid Test CE is a highly sensitive and specific tool for the detection of antibodies to Mycobacterium tuberculosis. It supports timely diagnosis and treatment decisions, especially in resource-limited and high TB burden settings.