title: MTB-DR-RIF 9G test: Detection and discrimination of tuberculosis and multi-drug resistant tuberculosis strains.
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.
authors.affiliation: Biometrix Technology, Inc. 202 BioVenture Plaza, Chuncheon, 200-161, Republic of Korea.
authors.forename: Keum-Soo
authors.initials: KS
authors.lastname: Song
authors.affiliation: Institute for Applied Chemistry and Department of Chemistry, Hallym University, Chuncheon, 200-702, Republic of Korea.
authors.forename: Satish Balasaheb
authors.initials: SB
authors.lastname: Nimse
authors.affiliation: Department of Pathology, College of Medicine, Yonsei University, Seoul, Republic of Korea.
authors.forename: Nam Hoon
authors.initials: NH
authors.lastname: Cho
authors.affiliation: National Masan Hospital, Clinical Research Center, Changwon, Republic of Korea.
authors.forename: Nackmoon
authors.initials: N
authors.lastname: Sung
authors.affiliation: Korea Mycobacterium Resource Center (KMRC), The Korean Institute of Tuberculosis, Cheongju-si, Republic of Korea.
authors.forename: Hee-Jin
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Korea Mycobacterium Resource Center (KMRC), The Korean Institute of Tuberculosis, Cheongju-si, Republic of Korea.
authors.forename: Jeongseong
authors.initials: J
authors.lastname: Yang
authors.affiliation: Institute for Applied Chemistry and Department of Chemistry, Hallym University, Chuncheon, 200-702, Republic of Korea. Electronic address: tskim@hallym.ac.kr.
authors.forename: Taisun
authors.initials: T
authors.lastname: Kim
mesh_terms: D000904:Antibiotics, Antitubercular / Q000627:therapeutic use*; D001426:Bacterial Proteins / Q000235:genetics*; D001431:Bacteriological Techniques; D004252:DNA Mutational Analysis; D004269:DNA, Bacterial / Q000235:genetics*; D012321:DNA-Directed RNA Polymerases / Q000235:genetics*; D003937:Diagnosis, Differential; D016002:Discriminant Analysis; D024901:Drug Resistance, Multiple, Bacterial / Q000235:genetics*; D006801:Humans; D025202:Molecular Diagnostic Techniques; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics*; D009693:Nucleic Acid Hybridization; D016133:Polymerase Chain Reaction; D020641:Polymorphism, Single Nucleotide; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012293:Rifampin / Q000627:therapeutic use*; D014376:Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000904:Antibiotics, Antitubercular; D001426:Bacterial Proteins; D004269:DNA, Bacterial; C505805:rpoB protein, Mycobacterium tuberculosis; D012321:DNA-Directed RNA Polymerases; D012293:Rifampin
keywords: Accuracy; Diagnosis; Drug resistant tuberculosis; Sensitivity; Specificity; Tuberculosis