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Evaluation of an immunochromatographic test kit for detecting Mycobacterium tuberculosis complex in sputum samples

Methawee Sutantangjai, Kiatichai Faksri, Kiatichai Fasksri

    The Southeast Asian Journal of Tropical Medicine and Public Health
    |June 28, 2014
    PubMed

    Insights

    The SD Bioline TB Ag MPT64 rapid test accurately detects Mycobacterium tuberculosis complex (MTC) in cultures but is ineffective for direct sputum diagnosis. This immunochromatographic assay (ICA) kit is unsuitable for evaluating sputum samples for tuberculosis.

    Area of Science:

    • Microbiology
    • Diagnostic Immunology
    • Infectious Disease Research

    Background:

    • Rapid and accurate tuberculosis (TB) diagnosis is crucial for effective TB control.
    • Existing diagnostic methods for Mycobacterium tuberculosis complex (MTC) require improvement in speed and accessibility.

    Purpose of the Study:

    • To evaluate the performance of the SD Bioline TB Ag MPT64 rapid test, an immunochromatographic assay (ICA) kit.
    • To determine the kit's efficacy in detecting MTC directly in sputum samples and in various culture types.

    Main Methods:

    • Optimized antigen extraction from sputum using various solvents and conditions.
    • Assessed ICA kit sensitivity and specificity on sputum samples (AFB stain positive/negative).
    • Evaluated kit performance on MTC-positive solid and liquid cultures, reference MTC strains, nontuberculous mycobacteria (NTM), and other bacteria.

    Main Results:

    • The ICA kit achieved 71.7% sensitivity and 100% specificity on sputum when pre-treated with a solvent.
    • Without solvent treatment, sputum MTC detection sensitivity was 0%.
    • The kit demonstrated 100% sensitivity and specificity for MTC in solid and liquid cultures and 100% specificity against NTM and other microorganisms.

    Conclusions:

    • The SD Bioline TB Ag MPT64 rapid test is highly effective for detecting MTC in solid and liquid cultures.
    • The kit is not suitable for direct diagnosis of tuberculosis from sputum samples, even with antigen extraction optimization.
    • The tested ICA kit is recommended solely for use with culture specimens.

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