title: Xpert MTB/RIF assay for diagnosis of pulmonary tuberculosis in children: a prospective, multi-centre evaluation.
abstract: BACKGROUND
  Following endorsement by the World Health Organisation, the Xpert MTB/RIF assay has been widely incorporated into algorithms for the diagnosis of adult tuberculosis (TB). However, data on its performance in children remain scarce. This prospective, multi-centre study evaluated the performance of Xpert MTB/RIF to diagnose pulmonary tuberculosis in children.
  
  
  METHODS
  Children older than eight weeks and younger than 16 years with suspected pulmonary tuberculosis were enrolled at three TB endemic settings in Tanzania and Uganda, and assigned to five well-defined case definition categories: culture-confirmed TB, highly probable TB, probable TB, not TB, or indeterminate. The diagnostic accuracy of Xpert MTB/RIF was assessed using culture-confirmed TB cases as reference standard.
  
  
  RESULTS
  In total, 451 children were enrolled. 37 (8%) had culture-confirmed TB, 48 (11%) highly probably TB and 62 probable TB (13%). The Xpert MTB/RIF assay had a sensitivity of 68% (95% CI, 50%-82%) and specificity of 100% (95% CI, 97%-100%); detecting 1.7 times more culture-confirmed cases than smear microscopy with a similar time to detection. Xpert MTB/RIF was positive in 2% (1/48) of highly probable and in 3% (2/62) of probable TB cases.
  
  
  CONCLUSIONS
  Xpert MTB/RIF provided timely results with moderate sensitivity and excellent specificity compared to culture. Low yields in children with highly probable and probable TB remain problematic.
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania. Electronic address: Klaus.Reither@unibas.ch.
authors.forename: Klaus
authors.initials: K
authors.lastname: Reither
authors.affiliation: National Institute of Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania.
authors.forename: Christina
authors.initials: C
authors.lastname: Manyama
authors.affiliation: National Institute of Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania; Division of Infectious Diseases and Tropical Medicine, Medical Center of The University of Munich (LMU), Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Clowes
authors.affiliation: Division of Infectious Diseases and Tropical Medicine, Medical Center of The University of Munich (LMU), Germany; German Centre for Infection Research (DZIF), Partner Site Munich, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Rachow
authors.affiliation: National Institute of Medical Research, Mbeya Medical Research Centre, Mbeya, Tanzania.
authors.forename: Daniel
authors.initials: D
authors.lastname: Mapamba
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Steiner
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.
authors.forename: Amanda
authors.initials: A
authors.lastname: Ross
authors.affiliation: Ifakara Health Institute, Bagamoyo, Tanzania.
authors.forename: Elirehema
authors.initials: E
authors.lastname: Mfinanga
authors.affiliation: Ifakara Health Institute, Bagamoyo, Tanzania.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Sasamalo
authors.affiliation: St. Francis Hospital Nsambya, AISPO, Kampala, Uganda.
authors.forename: Martin
authors.initials: M
authors.lastname: Nsubuga
authors.affiliation: St. Francis Hospital Nsambya, AISPO, Kampala, Uganda.
authors.forename: Francesco
authors.initials: F
authors.lastname: Aloi
authors.affiliation: Emerging Bacterial Pathogens, San Raffaele Scientific Institute, Milano, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Cirillo
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania.
authors.forename: Levan
authors.initials: L
authors.lastname: Jugheli
authors.affiliation: Ifakara Health Institute, Bagamoyo, Tanzania.
authors.forename: Fred
authors.initials: F
authors.lastname: Lwilla
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D008853:Microscopy; D009169:Mycobacterium tuberculosis; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D013636:Tanzania; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D014454:Uganda; D014944:World Health Organization
keywords: Childhood tuberculosis; Diagnostics; Evaluation; Pulmonary tuberculosis; Xpert MTB/RIF