MTB-DR-RIF 9G test: Detection and discrimination of tuberculosis and multi-drug resistant tuberculosis strains

Tuberculosis (Edinb). 2015 Dec;95(6):780-785. doi: 10.1016/j.tube.2015.08.008. Epub 2015 Sep 5.

Abstract

This report describes the evaluation of the novel MTB-DR-RIF 9G test for the accurate detection and discrimination of Mycobacterium tuberculosis (MTB) and rifampicin-resistant M. tuberculosis (MTB-DR-RIF) in the clinical samples. The procedure included the amplification of a nucleotide fragment of the rpoB gene of the MTB and MTB-DR-RIF strains and their hybridization with the immobilized probes. The MTB-DR-RIF 9G test was evaluated for its ability to detect and discriminate MTB and MTB-DR-RIF strains in 113 known clinical samples. The accuracy of the MTB-DR-RIF 9G test was determined by comparing its results with sequencing analysis and drug susceptibility testing. The sensitivity and specificity of the MTB-DR-RIF 9G test at 95% confidence interval were found to be 95.4% (89.5-98.5) and 100% (69.2-100), respectively. The positive predictive value and negative predictive value of the MTB-DR-RIF 9G test at 95% confidence interval were found to be 100% (85.0-95.9) and 66.7% (38.4-88.18), respectively. Sequencing analysis of all samples indicated that the mutations present in the regions identified with the MTB-DR-RIF 9G assay can be detected accurately.

Keywords: Accuracy; Diagnosis; Drug resistant tuberculosis; Sensitivity; Specificity; Tuberculosis.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibiotics, Antitubercular / therapeutic use*
  • Bacterial Proteins / genetics*
  • Bacteriological Techniques*
  • DNA Mutational Analysis
  • DNA, Bacterial / genetics*
  • DNA-Directed RNA Polymerases / genetics*
  • Diagnosis, Differential
  • Discriminant Analysis
  • Drug Resistance, Multiple, Bacterial / genetics*
  • Humans
  • Molecular Diagnostic Techniques*
  • Mutation
  • Mycobacterium tuberculosis / drug effects
  • Mycobacterium tuberculosis / genetics*
  • Nucleic Acid Hybridization
  • Polymerase Chain Reaction
  • Polymorphism, Single Nucleotide
  • Predictive Value of Tests
  • Reproducibility of Results
  • Rifampin / therapeutic use*
  • Tuberculosis / diagnosis*
  • Tuberculosis / drug therapy
  • Tuberculosis / microbiology
  • Tuberculosis, Multidrug-Resistant / diagnosis*
  • Tuberculosis, Multidrug-Resistant / drug therapy
  • Tuberculosis, Multidrug-Resistant / microbiology

Substances

  • Antibiotics, Antitubercular
  • Bacterial Proteins
  • DNA, Bacterial
  • rpoB protein, Mycobacterium tuberculosis
  • DNA-Directed RNA Polymerases
  • Rifampin