LIODetect® TB-ST

Intended Use & Test Principle

LIODetect® TB-ST detects antibodies associated with Mycobacterium tuberculosis infection in human samples. It is intended for professional use in point-of-care testing (POCT) and laboratory settings and should be applied as an aid in conjunction with clinical evaluation, patient history, and other laboratory findings.

The test is a lateral flow immunochromatographic assay. Patient antibodies bind to immobilized TB antigens on the test strip. Migration along the membrane produces visible lines indicating the presence of antibodies, while a control line confirms correct test performance. The assay detects IgG, IgA, and IgM classes of antibodies.

Test Kit Components

• Individually packaged test devices
• Sample buffer
• Instructions for Use (IFU)

Please refer to the IFU for detailed sample handling, storage, and performance information.

Technical Specifications

• Sample material: Human serum/plasma (see IFU)
• Technology: Lateral flow immunochromatography
• Time to result: 15-30 minutes
• Result: Qualitative
• Antibody classes: IgG, IgA, IgM
• Antigens: Selected recombinant M. tuberculosis antigens
• Storage conditions: See IFU

Citations

1. La Manna MP, Tamburini B, Orlando V, et al. LIODetect® TB-ST: Evaluation of novel blood test for a rapid diagnosis of active pulmonary and extra-pulmonary tuberculosis in IGRA confirmed patients. Tuberculosis (Edinb). 2021;130:102119. PMID: 34411890 Full text (PDF)