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

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....

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Autores principales: Nabeta, Pamela, Havumaki, Joshua, Ha, Dang Thi Minh, Caceres, Tatiana, Hang, Pham Thu, Collantes, Jimena, Thi Ngoc Lan, Nguyen, Gotuzzo, Eduardo, Denkinger, Claudia M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333855/
https://www.ncbi.nlm.nih.gov/pubmed/28253302
http://dx.doi.org/10.1371/journal.pone.0173092
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author Nabeta, Pamela
Havumaki, Joshua
Ha, Dang Thi Minh
Caceres, Tatiana
Hang, Pham Thu
Collantes, Jimena
Thi Ngoc Lan, Nguyen
Gotuzzo, Eduardo
Denkinger, Claudia M.
author_facet Nabeta, Pamela
Havumaki, Joshua
Ha, Dang Thi Minh
Caceres, Tatiana
Hang, Pham Thu
Collantes, Jimena
Thi Ngoc Lan, Nguyen
Gotuzzo, Eduardo
Denkinger, Claudia M.
author_sort Nabeta, Pamela
collection PubMed
description 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.
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spelling pubmed-53338552017-03-10 Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis Nabeta, Pamela Havumaki, Joshua Ha, Dang Thi Minh Caceres, Tatiana Hang, Pham Thu Collantes, Jimena Thi Ngoc Lan, Nguyen Gotuzzo, Eduardo Denkinger, Claudia M. PLoS One Research Article 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. Public Library of Science 2017-03-02 /pmc/articles/PMC5333855/ /pubmed/28253302 http://dx.doi.org/10.1371/journal.pone.0173092 Text en © 2017 Nabeta et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Nabeta, Pamela
Havumaki, Joshua
Ha, Dang Thi Minh
Caceres, Tatiana
Hang, Pham Thu
Collantes, Jimena
Thi Ngoc Lan, Nguyen
Gotuzzo, Eduardo
Denkinger, Claudia M.
Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title_full Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title_fullStr Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title_full_unstemmed Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title_short Feasibility of the TBDx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
title_sort feasibility of the tbdx automated digital microscopy system for the diagnosis of pulmonary tuberculosis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333855/
https://www.ncbi.nlm.nih.gov/pubmed/28253302
http://dx.doi.org/10.1371/journal.pone.0173092
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