Evaluation of an immunochromatographic assay kit for rapid identification of Mycobacterium tuberculosis complex in clinical isolates.

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Authors: Mi Young Park ; Young Jin Kim ; Sang Hyun Hwang ; Hyoung Hoi Kim ; Eun Yup Lee ; Seok Hoon Jeong ; Chulhun L. Chang

MeSH: Animals ; Antibodies, Monoclonal ; Bacteriological Techniques/methods* ; Chromatography, Affinity/methods* ; Humans ; Immunoassay ; Mice ; Mycobacterium tuberculosis/isolation & purification* ; Sensitivity and Specificity ; Tuberculosis/diagnosis* ; Tuberculosis/microbiology

Abstract: We evaluated a new immunochromatographic assay (ICA) using mouse monoclonal anti-MPT64 antibody for rapid discrimination between Mycobacterium tuberculosis and nontuberculous mycobacteria in clinical isolates. A study with mycobacteria and other organisms showed excellent sensitivity (approximately equal 99%) and specificity (100%) and an appropriate detection limit (10(5) CFU/ml) when tested with M. tuberculosis H37Rv. This ICA can simplify the identification of M. tuberculosis in clinical laboratories.