Diagnostic Utility of the Molecular Assay Genotype MTBC (HAIN Lifescience, Germany) for Identification of Tuberculous Mycobacteria

Introduction: The GenoType system (HAIN Lifescience, Germany) offers new perspectives of detecting the tuberculous and non-tuberculous mycobacteria at the molecular level. The system compromises five independent tests that could be performed either on direct specimens or isolated strains, to identify the strains and test the resistance against rifampin and isoniazid. Up to now, non GenoType test was applied in Poland. The aim of the study was an evaluation the accuracy of GenoType MTBC test in speciation of the clinical isolates, previously classified as M. tuberculosis complex by HPLC analyze of mycolic acids. Material and methods: 161 clinical isolates, derived from the TB patients hospitalized in the Warsaw Medical University Hospital between 1999 and 2007 were assayed. Results: On the basis of the hybridization patterns, all 161 studied strains were identified as M. tuberculosis/M. canettii. Conclusions: 1. The GenoType MTBC test (HAIN Lifescience, Germany) precisely recognizes M. tuberculosis complex. The 100% accordance in speciation of M. tuberculosis by the GenoType MTBC test as compared to HPLC method was demonstrated. The GenoType MTBC test can replace HPLC in detection of tuberculous mycobacteria in clinical isolates. 2. As the GenoType MTBC test performs well, the other tests of GenoType system may be considered to be verified indiagnostic procedure of mycobacterial infection.