title: Performance of microscopic observation drug susceptibility for the rapid diagnosis of tuberculosis and detection of drug resistance in Bamako, Mali.
abstract: OBJECTIVE
  In Mali early detection and treatment of multidrug-resistant tuberculosis (MDR-TB) are still challenging due to the cost, time and/or complexity associated with regular tests. Microscopic Observation Drug Susceptibility (MODS) is a low-cost assay validated by WHO in 2010. It is a liquid-culture-based assay to detect the 'cording' characteristic of Mycobacterium tuberculosis complex and to assess susceptibility to both isoniazid and rifampicin defining multidrug-resistant tuberculosis (MDR-TB). In this study we aimed to evaluate the performance of MODS as diagnostic tool compared with a validated method-Mycobacteria Growth Indicator Tube/Antimicrobial Susceptibility Testing/Streptomycin, Isoniazid, Rifampicin and Ethambutol (MGIT/AST/SIRE).
  
  
  RESULTS
  Between January 2010 and October 2015 we included 98 patients with suspected TB in an observational cohort study. The sensitivity and specificity of MODS assay for detecting TB were respectively 94.12% and 85.71% compared with the reference MGIT/7H11 culture, with a Cohen κ coefficient of 0.78 (95% CI 0.517-1.043). The median time to culture positivity for MODS assay and MGIT (plus interquartile range, IQR) was respectively 8 days (IQR 5-11) and 6 days (IQR 5-6). In detecting patients with MDR-TB, the sensitivity and specificity of MODS assay were respectively 100% and 95.92%. The positive predictive value and negative predictive value were, respectively, 66.7% and 100%. The median turnaround times for obtaining MDR-TB results using MODS assay and MGIT/AST/SIRE was respectively 9 days and 35 days. Hence, the MODS assay rapidly identifies MDR-TB in Mali compared with the MGIT/AST/SIRE.
  
  
  CONCLUSIONS
  As an easy, simple, fast and affordable method, the MODS assay could significantly improve the management of TB.
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: M
authors.initials: M
authors.lastname: Sanogo
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: B
authors.initials: B
authors.lastname: Kone
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali; Institute of Tropical Medicine (ITM), Biomedical Department, Antwerp, Belgium. Electronic address: bdiarra@icermali.org.
authors.forename: B
authors.initials: B
authors.lastname: Diarra
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali; Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, USA.
authors.forename: M
authors.initials: M
authors.lastname: Maiga
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: B
authors.initials: B
authors.lastname: Baya
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: A M
authors.initials: AM
authors.lastname: Somboro
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: Y S
authors.initials: YS
authors.lastname: Sarro
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: A C G
authors.initials: ACG
authors.lastname: Togo
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: B P P
authors.initials: BPP
authors.lastname: Dembele
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: D
authors.initials: D
authors.lastname: Goita
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: A
authors.initials: A
authors.lastname: Kone
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: O
authors.initials: O
authors.lastname: M'Baye
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: N
authors.initials: N
authors.lastname: Coulibaly
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: S
authors.initials: S
authors.lastname: Diabate
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: B
authors.initials: B
authors.lastname: Traore
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: M H
authors.initials: MH
authors.lastname: Diallo
authors.affiliation: Filariasis Unit of the Malaria Research and Training Centre (MRTC), USTTB, Bamako, Mali.
authors.forename: Y I
authors.initials: YI
authors.lastname: Coulibaly
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: P
authors.initials: P
authors.lastname: Saleeb
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
authors.forename: M
authors.initials: M
authors.lastname: Belson
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
authors.forename: S
authors.initials: S
authors.lastname: Orsega
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
authors.forename: S
authors.initials: S
authors.lastname: Siddiqui
authors.affiliation: Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
authors.forename: M A
authors.initials: MA
authors.lastname: Polis
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: S
authors.initials: S
authors.lastname: Dao
authors.affiliation: Division of Infectious Diseases, Northwestern University, Chicago, IL, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Murphy
authors.affiliation: SEREFO Laboratories of the University Clinical Research Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
authors.forename: S
authors.initials: S
authors.lastname: Diallo
mesh_terms: D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000494:pharmacology*; D015331:Cohort Studies; D042241:Early Diagnosis; D004977:Ethambutol / Q000494:pharmacology; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000494:pharmacology; D008297:Male; D008302:Mali; D008826:Microbial Sensitivity Tests / Q000379:methods*; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000648:ultrastructure*; D011446:Prospective Studies; D012293:Rifampin / Q000494:pharmacology; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin
keywords: 7H11 culture; Mali; Microscopic observation and drug susceptibility; Multidrug-resistant tuberculosis; Mycobacteria Growth Indicator Tube/Antimicrobial Susceptibility Testing/Sterptomycin, Isoniazid, Rifampicin and Ethambutol; Tuberculosis