Abstract
The MDR/MTB ELITe MGB® Kit on the ELITe InGenius® platform (ELITechGroup SpA, Italy) is the first system for simultaneous detection of the Mycobacterium tuberculosis complex (MTBc) genome and the main mutations responsible for resistance to Isoniazid (inhA, katG) and Rifampicin (rpoB), from decontaminated and heat inactivated samples. In this study we compared the performance of the MDR/MTB ELITe MGB® Kit (ELITe) with culture in 100 pulmonary and 160 extra-pulmonary samples. The sensitivity and specificity of ELITe compared to culture for pulmonary samples were 98.0% and 98.0% respectively; for extra-pulmonary samples the overall sensitivity was 86.3% (80% for urine, 85% for biopsy and gastric aspirate and 95% for cavitary fluid) and specificity was 100%. Genotypic Isoniazid and Rifampicin susceptibility typing was feasible in 96% of sputum MTBc-positive samples and 43% of extra-pulmonary samples; all samples were found to be drug susceptible by phenotypic and ELITe (100% agreement). Detection of mutations in the rpoB, kat G or inhA genes was evaluated on 300 spiked samples (60 per biological matrix) and all resistance profiles were correctly identified by ELITe. Molecular agreement between ELITe and Xpert was 98.0% and 93.3% for pulmonary and extra-pulmonary samples, respectively. In conclusion, our results provide evidence to support the use of MDR/MTB ELITe MGB® Kit in combination with ELITe InGenius® for the diagnosis of MTBc and the detection of Rifampicin and Isoniazid resistance-related mutations in both pulmonary and extra-pulmonary samples. This system simplifies the laboratory workflow, shortens report time and is an aid in choosing appropriate therapeutic treatment and patient management.
Highlights
According to the last WHO Tuberculosis (TB) report, in 2018 an estimated 10.0 million people fell ill with TB globally and an estimated 280,000 new and relapse TB cases occurred in the WHO European region
Processed Mycobacterium tuberculosis complex (MTBc) culture-negative specimens were spiked with 3 MTBc isolates which were phenotypically resistant to Rifampicin and/or Isoniazid, carrying mutations in the rpoB, katG or inhA genes
This is the first assessment of MDR/MTB ELITe MGB1 Kit (ELITe) performance on pulmonary and extra-pulmonary samples in comparison to MTBc culture in the literature to date
Summary
According to the last WHO Tuberculosis (TB) report, in 2018 an estimated 10.0 million (range, 9.0–11.1 million) people fell ill with TB globally and an estimated 280,000 new and relapse TB cases occurred in the WHO European region. Estimated cases of multidrug-resistant (MDR) and rifampicin-resistant (RR) TB among notified pulmonary cases in the European region and the global average of isoniazid resistance without concurrent rifampicin resistance was 7.2% in new TB cases and 11.6% in previously treated TB cases [1] The onset of this resistance is caused by incomplete treatment and/or inadequate therapy [2]. The assay workflow of the ELITe InGenius system integrates the extraction and purification of nucleic acids, real-time PCR amplification, detection of the target sequence with melt-curve capability and result interpretation In this retrospective study, we assessed the performance of the MDR/MTB ELITe MGB1 Kit (ELITe) on pulmonary and extra-pulmonary specimens in comparison with culture as well as its ability to detect Rifampicin and Isoniazid resistance on different specimen matrices spiked with three drug-resistant strains. Agreement with Xpert MTB/RIF(Cepheid, USA) was evaluated
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