Validation and implementation of GeneXpert MTB/RIF for diagnosis of Tuberculosis in Ecuador
Abstract
The objective of the study was the validation and implementation of GeneXpert MTB/RIF for routine use in the rapid detection of tuberculosis and sensitivity to rifampicin in clinical samples; for this, 1592 respiratory samples were collected and analyzed in the laboratory of Instituto Nacional de Investigación en Salud Pública Guayaquil. The analysis of the results of GeneXpert in comparison with smear microscopy showed an initial sensitivity of 99.8% and specificity of 93.2%; The analysis of discrepancies using the results of the culture as a reference method showed that the GeneXpert results considered false negatives turned out to be true negatives, the same happens with the false positives that correspond to true positives. Recalculated the sensitivity and specificity of the GeneXpert was 99.8% and 100% correspondingly. The comparison with the drugs susceptibility test showed a sensitivity of 91.4% and a specificity of 95.5% for the GeneXpert MTB/RIF system. It is concluded that the implementation of the GeneXpert system allows solution to certain problems associated with the application of conventional diagnostic methodologies, decreasing the waiting times, and increasing the sensitivity and specificity in the diagnosis of drug-resistant tuberculosis, thus generating a valuable opportunity for early diagnosis.References
Farga V, Camerino JA. Tuberculosis. 3ra ed. Buenos Aires: Editorial mediterraneo; 2011. 483 p.
World Health Organization. Global Tuberculosis Report 2016 [Internet]. World Health Organization. Ginebra: World Health Organization; 2016. Disponible en: http://www.who.int/tb/publications/global_report/en/
World Health Organization. Global Tuberculosis Report 2017 [Internet]. World Health Organization. Geneva; 2017 [citado 15 de enero de 2019]. Disponible en: https://extranet.who.int/tme
Herrera T, Arias F, Ruiz N, col. MANUAL OPERATIVO Implementación del GeneXpert MTB / RIF en el Programa de Tuberculosis [Internet]. Santiago de Chile: Ministerio de Salud. Gobierno de Chile; 2017 [citado 15 de enero de 2019]. 25 p. Disponible en: https://diprece.minsal.cl/wrdprss_minsal/wp-content/uploads/2018/02/2018.01.23_MANUAL-XPERT.pdf
Pantoja A, Fitzpatrick C, Vassall A, Weyer K, Floyd K. Xpert MTB/RIF for diagnosis of tuberculosis and drug-resistant tuberculosis: A cost and affordability analysis. Eur Respir J [Internet]. 2013;42(3):708-20. Disponible en: https://erj.ersjournals.com/content/42/3/708
Weyer K, Mirzayev F, Migliori GB, Van Gemert W, D’Ambrosio L, Zignol M, et al. Rapid molecular TB diagnosis: Evidence, policy making and global implementation of Xpert MTB/RIF. Eur Respir J [Internet]. 2013;42(1):252-71. Disponible en: https://erj.ersjournals.com/content/42/1/252
Uplekar M, Figueroa-Munoz J, Floyd K. The Stop TB Strategy: building on and enhancing DOTS to meet the TB-related Millennium Development Goals. [Internet]. WHO report. Geneva; 2006 [citado 15 de enero de 2019]. Disponible en: http://apps.who.int/iris/bitstream/handle/10665/69241/WHO_HTM_STB_2006.368_eng.pdf;jsessionid=F3A55CF227C99794463DA5069B2E9048?sequence=1
World Health Organization. CONSEJO EJECUTIVO EB134/12 134.a reunión 29 de noviembre de 2013 Punto 6.1 del orden del día provisional [Internet]. Geneva; 2013 [citado 15 de enero de 2019]. Disponible en: http://apps.who.int/gb/ebwha/pdf_files/EB134/B134_12-sp.pdf?ua=1
Khan MS, Dar O, Sismanidis C, Shah K, Godfrey-Faussett P. Improvement of tuberculosis case detection and reduction of discrepancies between men and women by simple sputum-submission instructions: a pragmatic randomised controlled trial. Lancet [Internet]. 9 de junio de 2007;369(9577):1955-60. DOI: https://doi.org/10.1016/S0140-6736(07)60916-7
Organización Panamericana de la Salud. Manual para el diagnostico bacteriológico de la tuberculosis: Normas y Guía Técnica. Parte I Baciloscopía [Internet]. Washington, D.C; 2008 [citado 16 de enero de 2019]. Disponible en: http://apps.who.int/iris/bitstream/handle/10665/166101/9789275330135.pdf?sequence=1&isAllowed=y
Organización Panamericana de la Salud. Manual para el diagnostico bacteriológico de la tuberculosis: Normas y Guía Técnica. Parte II Cultivo [Internet]. Washington DC; 2008 [citado 16 de enero de 2019]. Disponible en: http://iris.paho.org/xmlui/bitstream/handle/123456789/18616/tblabscultivo_2008.pdf?sequence=1&isAllowed=y
Nava O, Hassanhi M, Prieto L. Evaluación de la baciloscopia, cultivo y reacción en cadena de la polimerasa para el diagnóstico de tuberculosis pulmonar. Kasmera [Internet]. 2005 [citado 16 de enero de 2019];33(2):119-31. Disponible en: http://www.scielo.org.ve/scielo.php?script=sci_arttext&pid=S0075-52222005000200005
Vallejo P, Rodríguez J, Searle A, Farga V. Ensayo Xpert MTB/RIF en el diagnóstico de tuberculosis. Rev Chil enfermedades Respir [Internet]. 2015;31(2):127-31. Disponible en: http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-73482015000200010&lng=en&nrm=iso&tlng=en
Rice JP, Seifert M, Moser KS, Rodwell TC. Performance of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis and rifampin resistance in a low-incidence, high-resource setting. PLoS One [Internet]. 2017;12(10):1-15. DOI: https://doi.org/10.1371/journal.pone.0186139
Agapito J, Neyra V, Baldeviano C, Espinoza J, Accinelli R. Caracterización de las mutaciones en el gen rpoB asociadas a la resistencia a rifampicina y tipificación mediante RFLP (IS1610) en cepas de Mycobacterium Tuberculosis de pacientes con tuberculosis pulmonar. Enferm Torax [Internet]. 2003;46(1):9-24. Disponible en: http://sisbib.unmsm.edu.pe/bvrevistas/enfermedades_torax/v46_n1/caracte_muta.htm
Lee HY, Seong MW, Park SS, Hwang SS, Lee J, Park YS, et al. Diagnostic accuracy of Xpert® MTB/RIF on bronchoscopy specimens in patients with suspected pulmonary tuberculosis. Int J Tuberc Lung Dis [Internet]. 2013;17(7):917-21. Disponible en: http://www.ingentaconnect.com/content/10.5588/ijtld.12.0885
Zar HJ, Workman L, Isaacs W, Dheda K, Zemanay W, Nicol MP. Rapid diagnosis of pulmonary tuberculosis in African children in a primary care setting by use of Xpert MTB/RIF on respiratory specimens: A prospective study. Lancet Glob Heal [Internet]. 1 de agosto de 2013 [citado 16 de enero de 2019];1(2):e97-104. Disponible en: http://www.ncbi.nlm.nih.gov/pubmed/25104164
Shrestha P, Khanal H, Dahal P, Dongol P. Programmatic Impact of Implementing GeneXpert MTB/RIF Assay for the Detection of Mycobacterium Tuberculosis in Respiratory Specimens from Pulmonary Tuberculosis Suspected Patients in Resource Limited Laboratory Settings of Eastern Nepal. Open Microbiol J [Internet]. 2018;12(1):9-17. Disponible en: http://benthamopen.com/FULLTEXT/TOMICROJ-12-9
Copyright (c) 2019 José Marcelo Ortíz-Jimenes, Greta Franco-Sotomayor, Martha Ramos-Ramirez
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Kasmera journal is registered under a Creative Commons an Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), available at: https://creativecommons.org/licenses/by-nc-sa/4.0/deed.en; which guarantees the freedom to share-copy and redistribute the material in any medium or format and adapt-remix, transform and build from the material, provided that the name of the authors, the Department of Infectious and Tropical Diseases, Zulia´s University and Kasmera Journal, you must also provide a link to the original document and indicate if changes have been made.
The Department of Infectious and Tropical Diseases, University of Zulia and Kasmera Journal do not retain the rights to published manuscript and the contents are the sole responsibility of the authors, who retain their moral, intellectual, privacy and publicity rights. The guarantee on the intervention of the manuscript (revision, correction of style, translation, layout) and its subsequent dissemination is granted through a license of use and not through a transfer of rights, which represents the Kasmera Journal and Department Infectious Diseases, University of Zulia are exempt from any liability that may arise from ethical misconduct by the authors.
Kasmera is considered a green SHERPA/RoMEO journal, that is, it allows self-archiving of both the pre-print (draft of a manuscript) and the post-print (the corrected and peer-reviewed version) and even the final version (layout as it will be published in the journal) both in personal repositories and in institutional and databases.