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

Tuberculosis (TB) is a bacterial disease caused by organisms of the Mycobacterium tuberculosis complex (MTC). The definitive diagnosis of TB depends on the isolation and identification of the etiologic agent. Clinical identification of mycobacteria remains difficult and timeconsuming. Cultures in specific media can result not only in M. tuberculosis (MTB) growth but also growth of nontuberculous mycobacteria (NTM). Therefore, the analysis of cultured colonies should be able to discriminate between MTB and NTM to confirm MTB specifically. Commercial diagnostic methods employ molecular biological tests to provide quick and specific tests for the identification of MTC, but false positive results cannot be excluded and these tests remain costly in terms of specialised equipment, labour and time (Wang 2006).