title: Capilia™ TB-Neo assay: a new tool for rapid distinction between tuberculous and non-tuberculous mycobacteria.
abstract: The ability to rapidly distinguish between Mycobacterium tuberculosis complex (MTC) and non-tuberculous mycobacteria (NTM) is critical in clinical practice.
  
  
  
  To evaluate the usefulness of an immunochromatographic (IC) assay to distinguish between MTC and NTM.
  
  
  
  We analysed a panel of 145 cultures from 128 patients. The routine molecular identification approaches, such as the AccuProbe™ Mycobacterium tuberculosis complex culture identification test and GenoType(®) Mycobacterium assays, were used as reference methods.
  
  
  
  Of the 101 positive cultures, 98 were correctly identified using the Capilia™ TB-Neo Assay. Of the three discordant isolates, one was identified as M. bovis bacille Calmette-Guérin (BCG) and two as M. tuberculosis. Although we have not performed the sequencing of these strains, some false-negative results have been described due to mutations in the mpb64 gene or with some M. bovis BCG strains. We did not observe false-positive results or any cross-reaction with 22 NTM strains, 12 non-mycobacterial micro-organisms and 10 negative cultures.
  
  
  
  We report good overall performance (sensitivity 97%, specificity 100%, positive predictive value 100% and negative predictive value 96%) of this rapid assay that is easy to perform and interpret and does not require sample preparation, trained technicians or expensive equipment.
authors.affiliation: Clinical Pathology Department, São João Hospital Centre, Porto, Portugal; EPI Unit, Institute of Public Health, University of Porto, Porto, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Ramos
authors.affiliation: Clinical Pathology Department, São João Hospital Centre, Porto, Portugal.
authors.forename: T
authors.initials: T
authors.lastname: Carvalho
authors.affiliation: Clinical Pathology Department, São João Hospital Centre, Porto, Portugal.
authors.forename: M
authors.initials: M
authors.lastname: Ribeiro
authors.affiliation: Clinical Pathology Department, São João Hospital Centre, Porto, Portugal; EPI Unit, Institute of Public Health, University of Porto, Porto, Faculty of Medicine, University of Porto, Porto, Portugal.
authors.forename: J T
authors.initials: JT
authors.lastname: Guimarães
mesh_terms: D015373:Bacterial Typing Techniques; D002846:Chromatography, Affinity / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009165:Mycobacterium Infections, Nontuberculous / Q000175:diagnosis*; D009163:Mycobacterium bovis / Q000302:isolation & purification; D009169:Mycobacterium tuberculosis / Q000302:isolation & purification; D009170:Nontuberculous Mycobacteria / Q000302:isolation & purification; D011174:Portugal; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014376:Tuberculosis / Q000175:diagnosis*