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Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis

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dc.contributor.author Nabeta, Pamela
dc.contributor.author Havumaki, Joshua
dc.contributor.author Ha, Dang Thi Minh
dc.contributor.author Cáceres Nakiche, Tatiana
dc.contributor.author Hang, Pham Thu
dc.contributor.author Collantes, Jimena
dc.contributor.author Thi Ngoc Lan, Nguyen
dc.contributor.author Gotuzzo Herencia, José Eduardo
dc.contributor.author Denkinger, Claudia M.
dc.date.accessioned 2019-01-25T15:18:35Z
dc.date.available 2019-01-25T15:18:35Z
dc.date.issued 2017
dc.identifier.uri https://hdl.handle.net/20.500.12866/4657
dc.description.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. FINDINGS: 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. INTERPRETATION: 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. en_US
dc.language.iso eng
dc.publisher Public Library of Science
dc.relation.ispartofseries PLoS ONE
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Humans en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Prospective Studies en_US
dc.subject Feasibility Studies en_US
dc.subject Vietnam en_US
dc.subject Tuberculosis, Pulmonary/diagnosis en_US
dc.subject Automation en_US
dc.subject Microscopy/methods en_US
dc.title Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pone.0173092
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.07
dc.relation.issn 1932-6203


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