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

Submitted June 27, 2023

Published 2023-06-27

Artículos

Vol. 7 No. 1 (2023): Visión Antataura

Evaluation of the performance of the GeneXpert MTB/RIF assay in specimens with suspected extrapulmonary tuberculosis received at the C.H.DR.A.A.M. January 2020-December 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

Published: 2023-06-27

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Riquelme, O. T., & Moreno, J. (2023). Evaluation of the performance of the GeneXpert MTB/RIF assay in specimens with suspected extrapulmonary tuberculosis received at the C.H.DR.A.A.M. January 2020-December 2021. Visión Antataura, 7(1), 30–46. https://doi.org/10.48204/j.vian.v7n1.a3923

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Abstract

The performance of the GeneXpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis (TBEP) has not been investigated in Panama. The objective of the study was to evaluate the diagnostic accuracy of the GeneXpert MTB/RIF assay for various extrapulmonary samples relative to the reference method: MGIT/LJ (Mycobacteria Growth Indicator Tube/Lowenstein-Jensen) culture. A total of 200 clinical samples was obtained and tested for TBEP using the GeneXpert MTB/RIF assay and standard conventional methods (culture and direct smear). The sensitivity (S), specificity (E), positive predictive value (PPV), and negative predictive value (NPV) of the Xpert MTB/RIF assay for TBEP were 66.6%, 97.3%, 66.6, and 97.3%, respectively. The GeneXpert MTB/RIF assay was found to have good specificity, but its sensitivity is variable and will depend on the type of sample used. We conclude that the GeneXpert MTB/RIF represents a good tool for the diagnosis of TBEP, but a negative result will not rule out the disease. Therefore, it cannot be recommended to replace standard conventional tests for the diagnosis of TBEP, however, its use together with traditional methodologies improves diagnosis.

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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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