title: Significant clinical impact of a rapid molecular diagnostic test (Genotype MTBDRplus assay) to detect multidrug-resistant tuberculosis.
abstract: BACKGROUND
  There are limited data on the clinical impact of rapid diagnostic tests to detect multidrug-resistant tuberculosis (MDR-TB). We sought to determine whether the use of a molecular diagnostic test to detect MDR-TB improves clinical outcomes.
  
  
  METHODS
  A quasi-experimental study was conducted to analyze the impact of the Genotype MTBDRplus assay on clinical outcomes among patients with culture-confirmed pulmonary MDR-TB. Patients received treatment at the National Center for Tuberculosis and Lung Diseases in Tbilisi, Georgia. Time to MDR-TB treatment initiation, culture conversion, and infection control measures were compared to a time period prior to the implementation of the molecular test.
  
  
  RESULTS
  Of 152 MDR-TB patients, 72 (47%) were from prior to and 80 (53%) following implementation of the MTBDRplus assay ("post-implementation group"). Patients in the post-implementation group initiated a second-line treatment regimen more rapidly than those in the pre-implementation group (18.2 vs 83.9 days, P < .01). Among patients admitted to a "drug-susceptible" tuberculosis ward, those from the post-implementation group spent significantly fewer days on the drug-susceptible ward compared to patients in the pre-implementation group (10.0 vs 58.3 days, P < .01). Among patients with 24 weeks follow-up (n = 119), those in the post-implementation group had a higher rate of culture conversion at 24 weeks (86% vs 63%, P < .01) and a more rapid rate of time to culture conversion (adjusted hazard ratio [aHR] 4.15, 95% confidence interval [CI], 2.5-6.9).
  
  
  CONCLUSIONS
  The implementation of a rapid molecular diagnostic test led to significant clinical improvements including reduced time to initiation of MDR-TB treatment, culture conversion, and improved infection control practices.
authors.affiliation: National Center for Tuberculosis and Lung Diseases.
authors.forename: Maia
authors.initials: M
authors.lastname: Kipiani
authors.affiliation: Department of Public Health and Epidemiology, Davit Tvildiani Medical University, Tbilisi.
authors.forename: Veriko
authors.initials: V
authors.lastname: Mirtskhulava
authors.affiliation: National Center for Tuberculosis and Lung Diseases.
authors.forename: Nestani
authors.initials: N
authors.lastname: Tukvadze
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Heath, Georgia State University Departments of Epidemiology and Global Health, Emory Rollins School of Public Health.
authors.forename: Matthew
authors.initials: M
authors.lastname: Magee
authors.affiliation: Departments of Epidemiology and Global Health, Emory Rollins School of Public Health Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Henry M
authors.initials: HM
authors.lastname: Blumberg
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.
authors.forename: Russell R
authors.initials: RR
authors.lastname: Kempker
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use; D024901:Drug Resistance, Multiple, Bacterial / Q000235:genetics*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics*; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology / Q000517:prevention & control
chemical_list: D000995:Antitubercular Agents
keywords: MTBDRplus; clinical outcomes; drug-resistance; tuberculosis
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