Simultaneous detection of Mycobacterium tuberculosis complex and resistance to Rifampicin and Isoniazid by MDR/MTB ELITe MGB® Kit for the diagnosis of tuberculosis

100 pulmonary and 160 extra-pulmonary samples (sheet Samples) and 300 samples spiked with 3 MTB isolates phenotypically resistant to Rifampicin and/or Isoniazid, carrying mutations in the rpoB, katG or inhA genes (sheet Spikes) were tested with MDR/MTB ELITe MGB® Kit (ELITe) on ELITe InGenius system and performance (sensitivity and specificity) were elaborated in comparison with culture.The study was conducted at the Unit of Microbiology of the S. Orsola-Malpighi University Hospital in Bologna (Italy).Database reports smear microscopy, mycobacterial culture, MTB drug susceptibility, Xpert MTB/RIF Ultra results, sample type, ELITe results about MTB DNA and resistances detection, Ct and melting temperature of MTB IS6110, rpoB, katG and inhA genes.