Evaluación del rendimiento del ensayo GeneXpert MTB/RIF en muestras con sospecha de tuberculosis extrapulmonar recibidas en el C.H.DR.A.A.M. de enero 2020-diciembre 2021

Oneira T. Riquelme; José Moreno

doi:10.48204/j.vian.v7n1.a3923

Enviado junio 27, 2023

Publicado 2023-06-27

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Vol. 7 Núm. 1 (2023): Visión Antataura

Evaluación del rendimiento del ensayo GeneXpert MTB/RIF en muestras con sospecha de tuberculosis extrapulmonar recibidas en el C.H.DR.A.A.M. de enero 2020-diciembre 2021

Oneira T. Riquelme⁺⁻
José Moreno⁺⁻

DOI https://doi.org/10.48204/j.vian.v7n1.a3923

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DOI: 10.48204/j.vian.v7n1.a3923

Publicado: 2023-06-27

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Riquelme, O. T., & Moreno, J. (2023). Evaluación del rendimiento del ensayo GeneXpert MTB/RIF en muestras con sospecha de tuberculosis extrapulmonar recibidas en el C.H.DR.A.A.M. de enero 2020-diciembre 2021. Visión Antataura, 7(1), 30–46. https://doi.org/10.48204/j.vian.v7n1.a3923

Derechos de autor 2023 Visión Antataura

Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial-CompartirIgual 4.0.

Resumen

El rendimiento del ensayo GeneXpert MTB/RIF para el diagnóstico de la tuberculosis extrapulmonar (TBEP) no se ha investigado en Panamá. El objetivo del estudio fue evaluar la precisión diagnóstica del ensayo GeneXpert MTB/RIF para diversas muestras extrapulmonares en relación con el método de referencia: cultivo MGIT/LJ (Mycobacteria Growth Indicator Tube/Lowenstein-Jensen). Obtuvimos un total de 200 muestras clínicas y se analizaron para detectar TBEP mediante el ensayo GeneXpert MTB/RIF y métodos convencionales estándar (cultivo y frotis directo). La sensibilidad (S), la especificidad (E), el valor predictivo positivo (VPP) y el valor predictivo negativo (VPN) del ensayo Xpert MTB/RIF para TBEP fueron del del 66.6 %, 97.3 %, 66.6 y 97.3 %, respectivamente. Se encontró que el ensayo GeneXpert MTB/RIF tiene buena especificidad, pero su sensibilidad es variable y dependerá del tipo de muestra utilizada. Concluimos que el GeneXpert MTB/RIF representa una buena herramienta para el diagnóstico de TBEP, pero un resultado negativo, no descartará la enfermedad. Por lo tanto, no puede recomendarse para reemplazar las pruebas convencionales estándar para el diagnóstico de TBEP, sin embargo, su uso junto a las metodologías tradicionales mejora el diagnóstico.

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Amicosante, M., D’Ambrosio, L., Munoz, M., Mello, F. C. de Q., Tebruegge, M., Chegou, N. N., Seghrouchni, F., Centis, R., Goletti, D., Bothamley, G., & Migliori, G. B. (2017). Current use and acceptability of novel diagnostic tests for active tuberculosis: a worldwide survey. Jornal Brasileiro de Pneumologia, 43(5), 380–392. https://doi.org/10.1590/s1806-37562017000000219.
Ballif, M., Kiertiburanakul, S., Chenal, H., Yotebieng, M., Grinsztejn, B., Michael, D., Sterling, T., Ngonyani, K., Mandalakas, A., Egger, M., Pettit, A. & Fenner, L. (2019). Diagnosis and clinical outcomes of extrapulmonary tuberculosis in antiretroviral therapy programmes in low- and middle-income countries: a multicohort study. Journal of the international AIDS society, 22 (9), 1–10. https://doi.org/10.1002/jia2.25392
Binjomah, A. Z., Alnimr, A. M., Zareah, S. M., Alharbi, S. F., Alasmari, K. S., Aldosari, K. M., & Alduealej, I. M. (2021). The diagnostic impact of implementing a molecular-based algorithm to standard mycobacterial screening at a reference laboratory with an intermediate prevalence for non-respiratory samples. Saudi Journal of Biological Sciences, 28(8), 4103–4108. https://doi.org/10.1016/j.sjbs.2021.05.080.
Chaves, W., Buitrago, J., Dueñas, A. & Bejarano, J. (2017). Acerca de la tuberculosis extrapulmonar. Repertorio de Medicina y Cirugía, 26(2), 90–97. https://doi.org/10.1016/j.reper.2017.04.004
Davis, A., Rohlwink, U., Proust, A., Figaji, A. & Wilkinson, R. (2019). The pathogenesis of tuberculous meningitis. Journal of Leukocyte Biology, 105(2), 267–280. https://doi.org/10.1002/JLB.MR0318-102R
De Oliveira Tomaz, A., Raboni, S., Kussen, G., Da Silva Nogueira, K., Ribeiro, C., & Costa, L. (2021). The Xpert® MTB/RIF diagnostic test for pulmonary and extrapulmonary tuberculosis in immunocompetent and immunocompromised patients: Benefits and experiences over 2 years in different clinical contexts. PLoS ONE, 16(3) e0247185. https://doi.org/10.1371/journal.pone.0247185.
Diallo, A., Kollo, A., Camara, M., Lo, S., Ossoga, G., Mbow, M., Karam, F., Niang, M., Thiam, A., Diawara, A., Mboup, S., & Diallo, A. (2016). Performance du GeneXpert MTB/RIF® dans le diagnostic de la tuberculose extra-pulmonaire à Dakar: 2010-2015. Pan African Medical Journal, 25, 2010–2015. https://doi.org/10.11604/pamj.2016.25.129.10065.
Donovan, J., Thu, D., Phu, N., Dung, V., Quang, T., Nghia, H., Oanh, P., Nhu, T., Chau, N., Ha, V., Hang, V., Trinh, D., Geskus, R., Tan, L., Thuong, N. & Thwaites, G. (2020). Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study. The Lancet Infectious Diseases, 20(3), 299–307. https://doi.org/10.1016/S1473-3099(19)30649-8
Elbrolosy, A., El Helbawy, R., Mansour, O., & Latif, R. (2021). Diagnostic utility of GeneXpert MTB/RIF assay versus conventional methods for diagnosis of pulmonary and extra-pulmonary tuberculosis. BMC Microbiology, 21(1), 1–10. https://doi.org/10.1186/s12866-021-02210-5.
Hibah, N., and others. (2015). Extrapulmonary tuberculosis situation in El-Behira Governorate, Egypt. Egyptian Journal of Bronchology, 9(1), 96. https://doi.org/10.4103/1687-8426.153662.
Kang, W., Yu, J., Du, J., Yang, S., Chen, H., Liu, J., Ma, J., Li, M., Qin, J., Shu, W., Zong, P., Zhang, Y., Dong, Y., Yang, Z., Mei, Z., Deng, Q., Wang, P., Han, W., Wu, M., … Tang, S. (2020). The epidemiology of extrapulmonary tuberculosis in China: A large-scale multicenter observational study. PLoS ONE, 15(8), 1–15. https://doi.org/10.1371/journal.pone.0237753.
Kohli, M., Schiller, I., Dendukuri, N., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2018b). Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews, 2018(8). https://doi.org/10.1002/14651858.CD012768.pub2.
Kohli, M., Schiller, I., Dendukuri, N., Yao, M., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2021). Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews, 2021(1). https://doi.org/10.1002/14651858.CD012768.pub3.
Mechal, Y., Benaissa, E., El Mrimar, N., Benlahlou, Y., Bssaibis, F., Zegmout, A., Chadli, M., Malik, Y. S., Touil, N., Abid, A., Maleb, A., & Elouennass, M. (2019). Evaluation of GeneXpert MTB/RIF system performances in the diagnosis of extrapulmonary tuberculosis. BMC Infectious Diseases, 19(1), 1–8. https://doi.org/10.1186/s12879-019-4687-7.
Metcalf, T., Soria, J., Montano, S., Ticona, E., Evans, C., Huaroto, L., Kasper, M., Ramos, E., Mori, N., Jittamala, P., Chotivanich, K., Chavez, I., Singhasivanon, P., Pukrittayakamee, S., & Zunt, J. (2018). Evaluation of the GeneXpert MTB/RIF in patients with presumptive tuberculous meningitis. PLoS ONE, 13(6), 1–15. https://doi.org/10.1371/journal.pone.0198695.
Moule, M. & Cirillo, J. (2020). Mycobacterium tuberculosis Dissemination Plays a Critical Role in Pathogenesis. Frontiers in Cellular and Infection Microbiology, 10, 1–12. https://doi.org/10.3389/fcimb.2020.00065
Natali, D., Cloatre, G., Brosset, C., Verdalle, P., Fauvy, A., Massart, J., Van, Q., Gerard, N., Dobler, C. & Hovette, P. (2020). What pulmonologists need to know about extrapulmonary tuberculosis. Breathe, 16(4), 1–18. https://doi.org/10.1183/20734735.0216-2020
Oulter, C. H. C. (2021). Evaluation of the GeneXpert MTB / RIF assay on extrapulmonary and respiratory samples other than sputum?: a low burden country experience. Pathology, 49(1), 70–74. https://doi.org/10.1016/j.pathol.2016.10.004.
Pang, Y., An, J., Shu, W., Huo, F., Chu, N., Gao, M., Qin, S., Huang, H., Chen, X., & Xu, S. (2019). Epidemiology of extrapulmonary tuberculosis among inpatients, China, 2008-2017. Emerging Infectious Diseases, 25(3), 457–464. https://doi.org/10.3201/eid2503.180572.
Peñata, A., Salazar, R., Castaño, T., Bustamante, J. & Ospina, S. (2016). Diagnóstico molecular de tuberculosis extrapulmonar y sensibilidad a rifampicina con un método automatizado en tiempo real. Biomédica, 36, 78–89. https://doi.org/10.7705/biomedica.v36i3.3088
Qian, X., Nguyen, D., Lyu, J., Albers, A., Bi, X., & Graviss, E. A. (2018). Risk factors for extrapulmonary dissemination of tuberculosis and associated mortality during treatment for extrapulmonary tuberculosis article. Emerging Microbes and Infections, 7(1), 1–14. https://doi.org/10.1038/s41426-018-0106-1.
Siddiqi, O., Birbeck, G., Ghebremichael, M., Mubanga, E., Love, S., Buback, C., Kosloff, B., Ayles, H., Atadzhanov, M., Dheda, K., & Koralnik, I. (2019). Prospective cohort study on performance of cerebrospinal fluid (CSF) Xpert MTB/RIF, CSF lipoarabinomannan (LAM) lateral flow assay (LFA), and urine LAM LFA for diagnosis of tuberculous meningitis in Zambia. Journal of Clinical Microbiology, 57(8), 1–9. https://doi.org/10.1128/JCM.00652-19
Vergara, A., González, J. y García-Basteiro, A. (2017). Xpert® MTB/RIF: utilidad en el diagnóstico de la tuberculosis y de la resistencia a la rifampicina. Medicina Clinica, 149(9), 399–405. https://doi.org/10.1016/j.medcli.2017.06.007.
Yu, G., Zhong, F., Ye, B., Xu, X., Chen, D. & Shen, Y. (2019). Diagnostic Accuracy of the Xpert MTB/RIF Assay for Lymph Node Tuberculosis: A Systematic Review and Meta-Analysis. BioMed Research International, 2019(4878240). https://doi.org/10.1155/2019/4878240

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[1] Amicosante, M., D’Ambrosio, L., Munoz, M., Mello, F. C. de Q., Tebruegge, M., Chegou, N. N., Seghrouchni, F., Centis, R., Goletti, D., Bothamley, G., & Migliori, G. B. (2017). Current use and acceptability of novel diagnostic tests for active tuberculosis: a worldwide survey. Jornal Brasileiro de Pneumologia, 43(5), 380–392. https://doi.org/10.1590/s1806-37562017000000219.

[2] Ballif, M., Kiertiburanakul, S., Chenal, H., Yotebieng, M., Grinsztejn, B., Michael, D., Sterling, T., Ngonyani, K., Mandalakas, A., Egger, M., Pettit, A. & Fenner, L. (2019). Diagnosis and clinical outcomes of extrapulmonary tuberculosis in antiretroviral therapy programmes in low- and middle-income countries: a multicohort study. Journal of the international AIDS society, 22 (9), 1–10. https://doi.org/10.1002/jia2.25392

[3] Binjomah, A. Z., Alnimr, A. M., Zareah, S. M., Alharbi, S. F., Alasmari, K. S., Aldosari, K. M., & Alduealej, I. M. (2021). The diagnostic impact of implementing a molecular-based algorithm to standard mycobacterial screening at a reference laboratory with an intermediate prevalence for non-respiratory samples. Saudi Journal of Biological Sciences, 28(8), 4103–4108. https://doi.org/10.1016/j.sjbs.2021.05.080.

[4] Chaves, W., Buitrago, J., Dueñas, A. & Bejarano, J. (2017). Acerca de la tuberculosis extrapulmonar. Repertorio de Medicina y Cirugía, 26(2), 90–97. https://doi.org/10.1016/j.reper.2017.04.004

[5] Davis, A., Rohlwink, U., Proust, A., Figaji, A. & Wilkinson, R. (2019). The pathogenesis of tuberculous meningitis. Journal of Leukocyte Biology, 105(2), 267–280. https://doi.org/10.1002/JLB.MR0318-102R

[6] De Oliveira Tomaz, A., Raboni, S., Kussen, G., Da Silva Nogueira, K., Ribeiro, C., & Costa, L. (2021). The Xpert® MTB/RIF diagnostic test for pulmonary and extrapulmonary tuberculosis in immunocompetent and immunocompromised patients: Benefits and experiences over 2 years in different clinical contexts. PLoS ONE, 16(3) e0247185. https://doi.org/10.1371/journal.pone.0247185.

[7] Diallo, A., Kollo, A., Camara, M., Lo, S., Ossoga, G., Mbow, M., Karam, F., Niang, M., Thiam, A., Diawara, A., Mboup, S., & Diallo, A. (2016). Performance du GeneXpert MTB/RIF® dans le diagnostic de la tuberculose extra-pulmonaire à Dakar: 2010-2015. Pan African Medical Journal, 25, 2010–2015. https://doi.org/10.11604/pamj.2016.25.129.10065.

[8] Donovan, J., Thu, D., Phu, N., Dung, V., Quang, T., Nghia, H., Oanh, P., Nhu, T., Chau, N., Ha, V., Hang, V., Trinh, D., Geskus, R., Tan, L., Thuong, N. & Thwaites, G. (2020). Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study. The Lancet Infectious Diseases, 20(3), 299–307. https://doi.org/10.1016/S1473-3099(19)30649-8

[9] Elbrolosy, A., El Helbawy, R., Mansour, O., & Latif, R. (2021). Diagnostic utility of GeneXpert MTB/RIF assay versus conventional methods for diagnosis of pulmonary and extra-pulmonary tuberculosis. BMC Microbiology, 21(1), 1–10. https://doi.org/10.1186/s12866-021-02210-5.

[10] Hibah, N., and others. (2015). Extrapulmonary tuberculosis situation in El-Behira Governorate, Egypt. Egyptian Journal of Bronchology, 9(1), 96. https://doi.org/10.4103/1687-8426.153662.

[11] Kang, W., Yu, J., Du, J., Yang, S., Chen, H., Liu, J., Ma, J., Li, M., Qin, J., Shu, W., Zong, P., Zhang, Y., Dong, Y., Yang, Z., Mei, Z., Deng, Q., Wang, P., Han, W., Wu, M., … Tang, S. (2020). The epidemiology of extrapulmonary tuberculosis in China: A large-scale multicenter observational study. PLoS ONE, 15(8), 1–15. https://doi.org/10.1371/journal.pone.0237753.

[12] Kohli, M., Schiller, I., Dendukuri, N., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2018b). Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews, 2018(8). https://doi.org/10.1002/14651858.CD012768.pub2.

[13] Kohli, M., Schiller, I., Dendukuri, N., Yao, M., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2021). Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews, 2021(1). https://doi.org/10.1002/14651858.CD012768.pub3.

[14] Mechal, Y., Benaissa, E., El Mrimar, N., Benlahlou, Y., Bssaibis, F., Zegmout, A., Chadli, M., Malik, Y. S., Touil, N., Abid, A., Maleb, A., & Elouennass, M. (2019). Evaluation of GeneXpert MTB/RIF system performances in the diagnosis of extrapulmonary tuberculosis. BMC Infectious Diseases, 19(1), 1–8. https://doi.org/10.1186/s12879-019-4687-7.

[15] Metcalf, T., Soria, J., Montano, S., Ticona, E., Evans, C., Huaroto, L., Kasper, M., Ramos, E., Mori, N., Jittamala, P., Chotivanich, K., Chavez, I., Singhasivanon, P., Pukrittayakamee, S., & Zunt, J. (2018). Evaluation of the GeneXpert MTB/RIF in patients with presumptive tuberculous meningitis. PLoS ONE, 13(6), 1–15. https://doi.org/10.1371/journal.pone.0198695.

[16] Moule, M. & Cirillo, J. (2020). Mycobacterium tuberculosis Dissemination Plays a Critical Role in Pathogenesis. Frontiers in Cellular and Infection Microbiology, 10, 1–12. https://doi.org/10.3389/fcimb.2020.00065

[17] Natali, D., Cloatre, G., Brosset, C., Verdalle, P., Fauvy, A., Massart, J., Van, Q., Gerard, N., Dobler, C. & Hovette, P. (2020). What pulmonologists need to know about extrapulmonary tuberculosis. Breathe, 16(4), 1–18. https://doi.org/10.1183/20734735.0216-2020

[18] Oulter, C. H. C. (2021). Evaluation of the GeneXpert MTB / RIF assay on extrapulmonary and respiratory samples other than sputum?: a low burden country experience. Pathology, 49(1), 70–74. https://doi.org/10.1016/j.pathol.2016.10.004.

[19] Pang, Y., An, J., Shu, W., Huo, F., Chu, N., Gao, M., Qin, S., Huang, H., Chen, X., & Xu, S. (2019). Epidemiology of extrapulmonary tuberculosis among inpatients, China, 2008-2017. Emerging Infectious Diseases, 25(3), 457–464. https://doi.org/10.3201/eid2503.180572.

[20] Peñata, A., Salazar, R., Castaño, T., Bustamante, J. & Ospina, S. (2016). Diagnóstico molecular de tuberculosis extrapulmonar y sensibilidad a rifampicina con un método automatizado en tiempo real. Biomédica, 36, 78–89. https://doi.org/10.7705/biomedica.v36i3.3088

[21] Qian, X., Nguyen, D., Lyu, J., Albers, A., Bi, X., & Graviss, E. A. (2018). Risk factors for extrapulmonary dissemination of tuberculosis and associated mortality during treatment for extrapulmonary tuberculosis article. Emerging Microbes and Infections, 7(1), 1–14. https://doi.org/10.1038/s41426-018-0106-1.

[22] Siddiqi, O., Birbeck, G., Ghebremichael, M., Mubanga, E., Love, S., Buback, C., Kosloff, B., Ayles, H., Atadzhanov, M., Dheda, K., & Koralnik, I. (2019). Prospective cohort study on performance of cerebrospinal fluid (CSF) Xpert MTB/RIF, CSF lipoarabinomannan (LAM) lateral flow assay (LFA), and urine LAM LFA for diagnosis of tuberculous meningitis in Zambia. Journal of Clinical Microbiology, 57(8), 1–9. https://doi.org/10.1128/JCM.00652-19

[23] Vergara, A., González, J. y García-Basteiro, A. (2017). Xpert® MTB/RIF: utilidad en el diagnóstico de la tuberculosis y de la resistencia a la rifampicina. Medicina Clinica, 149(9), 399–405. https://doi.org/10.1016/j.medcli.2017.06.007.

[24] Yu, G., Zhong, F., Ye, B., Xu, X., Chen, D. & Shen, Y. (2019). Diagnostic Accuracy of the Xpert MTB/RIF Assay for Lymph Node Tuberculosis: A Systematic Review and Meta-Analysis. BioMed Research International, 2019(4878240). https://doi.org/10.1155/2019/4878240

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