title: Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis.
abstract: BACKGROUND
  Improved and affordable diagnostic or triage tests are urgently needed at the microscopy centre level. Automated digital microscopy has the potential to overcome issues related to conventional microscopy, including training time requirement and inconsistencies in results interpretation.
  
  
  METHODS
  For this blinded prospective study, sputum samples were collected from adults with presumptive pulmonary tuberculosis in Lima, Peru and Ho Chi Minh City, Vietnam. TBDx performance was evaluated as a stand-alone and as a triage test against conventional microscopy and Xpert, with culture as the reference standard. Xpert was used to confirm positive cases.
  
  
  RESULTS
  A total of 613 subjects were enrolled between October 2014 and March 2015, with 539 included in the final analysis. The sensitivity of TBDx was 62·2% (95% CI 56·6-67·4) and specificity was 90·7% (95% CI 85·9-94·2) compared to culture. The algorithm assessing TBDx as a triage test achieved a specificity of 100% while maintaining sensitivity.
  
  
  CONCLUSIONS
  While the diagnostic performance of TBDx did not reach the levels obtained by experienced microscopists in reference laboratories, it is conceivable that it would exceed the performance of less experienced microscopists. In the absence of highly sensitive and specific molecular tests at the microscopy centre level, TBDx in a triage-testing algorithm would optimize specificity and limit overall cost without compromising the number of patients receiving up-front drug susceptibility testing for rifampicin. However, the algorithm would miss over one third of patients compared to Xpert alone.
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Pamela
authors.identifier: http://orcid.org/0000-0002-5395-6191
authors.initials: P
authors.lastname: Nabeta
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Joshua
authors.initials: J
authors.lastname: Havumaki
authors.affiliation: TB Department, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Dang Thi Minh
authors.initials: DT
authors.lastname: Ha
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Caceres
authors.affiliation: TB Department, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Pham Thu
authors.initials: PT
authors.lastname: Hang
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Jimena
authors.initials: J
authors.lastname: Collantes
authors.affiliation: TB Department, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Nguyen
authors.initials: N
authors.lastname: Thi Ngoc Lan
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Gotuzzo
authors.affiliation: FIND, Geneva, Switzerland.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
mesh_terms: D001331:Automation; D005240:Feasibility Studies; D006801:Humans; D008853:Microscopy / Q000379:methods*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis*; D014744:Vietnam