Validation of an immunochromatographic assay kit for the identification of the Mycobacterium tuberculosis complex

ABSTRACT

The performance of the immunochromatographic assay, SD BIOLINE TB Ag MPT64 RAPID®, was evaluated in Madagascar. Using mouse anti-MPT64 monoclonal antibodies for rapid discrimination between the Mycobacterium tuberculosis complex and nontuberculous mycobacteria, the kit was tested on mycobacteria and other pathogens using conventional methods as the gold standard. The results presented here indicate that this kit has excellent sensitivity (100 percent) and specificity (100 percent) compared to standard biochemical detection and can be easily used for the rapid identification of M. tuberculosis complex.