title: Evaluation of a novel line-probe assay for genotyping-based diagnosis of Mycobacterium tuberculosis in Thailand.
abstract: METHODS
  The Supranational Tuberculosis Reference Laboratory (NTRL), Bangkok, and Chiangrai Prachanukroh Hospital, Chiangrai, Thailand
  
  
  OBJECTIVE
  To evaluate the diagnostic performance of newly developed line-probe assay (LiPA) kits in tuberculosis (TB) endemic settings.
  
  
  METHODS
  LiPA kits were used to evaluate 404 clinical isolates of Mycobacterium species and 163 sputum samples in Thailand.
  
  
  RESULTS
  LiPA kits were able to identify M. tuberculosis, M. avium, M. intracellulare and M. kansasii with 100% sensitivity and specificity when compared with the commercially available AccuProbe assay. Testing of the LiPA kits for their ability to detect mutations in clinical isolates resistant to anti-tuberculosis drugs such as rifampicin, isoniazid, pyrazinamide and fluoroquinolones showed that the assay had very high sensitivity (65.9-100%) and specificity (98.2-100%) compared with drug susceptibility testing and DNA sequencing. LiPA had a sensitivity of 75.0-85.7% and a specificity of 96.4-100% in testing clinical sputum samples.
  
  
  CONCLUSIONS
  The novel LiPA kits have high sensitivity and specificity, and may enhance the rapid detection of first- and second-line anti-tuberculosis drug resistance, improving the selection of suitable chemotherapy agents to treat multidrug-resistant and extensively drug-resistant TB.
authors.affiliation: Supra-National Tuberculosis Reference Laboratory, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.
authors.forename: S
authors.initials: S
authors.lastname: Rienthong
authors.affiliation: Supra-National Tuberculosis Reference Laboratory, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.
authors.forename: C
authors.initials: C
authors.lastname: Boonin
authors.affiliation: TB-HIV Research Foundation, Chiangrai, Thailand.
authors.forename: B
authors.initials: B
authors.lastname: Chaiyasirinrote
authors.affiliation: Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
authors.forename: N
authors.initials: N
authors.lastname: Satproedprai
authors.affiliation: Medical Life Sciences Institute, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand.
authors.forename: S
authors.initials: S
authors.lastname: Mahasirimongkol
authors.affiliation: Research and Development Laboratory, Nipro Corporation, Shiga, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Yoshida
authors.affiliation: Research and Development Laboratory, Nipro Corporation, Shiga, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kondo
authors.affiliation: Supra-National Tuberculosis Reference Laboratory, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.
authors.forename: C
authors.initials: C
authors.lastname: Namwat
authors.affiliation: Supra-National Tuberculosis Reference Laboratory, Department of Disease Control, Ministry of Public Health, Bangkok, Thailand.
authors.forename: D
authors.initials: D
authors.lastname: Rienthong
mesh_terms: D000904:Antibiotics, Antitubercular / Q000627:therapeutic use; D054908:Extensively Drug-Resistant Tuberculosis / Q000175:diagnosis* / Q000188:drug therapy* / Q000235:genetics*; D024841:Fluoroquinolones / Q000627:therapeutic use; D005838:Genotype; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D008826:Microbial Sensitivity Tests; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification*; D011718:Pyrazinamide / Q000627:therapeutic use; D011933:Reagent Kits, Diagnostic / Q000145:classification*; D012293:Rifampin / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D013785:Thailand
chemical_list: D000904:Antibiotics, Antitubercular; D024841:Fluoroquinolones; D011933:Reagent Kits, Diagnostic; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin