Performance of the Xpert® MTB/RIF test in the laboratory detection of tuberculosis in pulmonary and extrapulmonary samples

Authors

DOI:

https://doi.org/10.33448/rsd-v10i7.16533

Keywords:

Tuberculosis; Molecular diagnostic techniques; Early diagnosis.

Abstract

Objective: To evaluate the diagnostic performance of Xpert® MTB/RIF in the state of Goiás, Brazil. Methodology: Cross-sectional study based on records filed in the Mycobacteria Section of a reference laboratory in the diagnosis of diseases of interest in public health in the state of Goiás. Data were collected on samples linked to suspected cases of tuberculosis processed in the period between October 2017 and October 2018. Pulmonary and extrapulmonary samples that presented Xpert® MTB/RIF results and culture were included in the study. The information collected was used to compose a database with the following variables: clinical specimen, result of Xpert® MTB/RIF, result of culture and type of culture (solid or liquid). For calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), growth in culture was taken as a reference. Results: 3262 samples were eligible for the study, 3068 of pulmonary origin (94.1%) and 194 of extrapulmonary origin (5.9%). The Xpert® MTB/RIF showed general sensitivity and specificity of 87.1% and 97.6% for samples of pulmonary origin and 80.0% and 97.3% for samples of extrapulmonary origin. The test performance varied according to the clinical sample and the type of culture taken as a reference. Conclusion: The Xpert® MTB/RIF test demonstrated in the present study to be an important diagnostic tool for cases of tuberculosis in both pulmonary and extrapulmonary samples, with good sensitivity and specificity. The results, as with any other methodology, should be interpreted with caution and based on the association of clinical, epidemiological and laboratory criteria.

References

Atehortúa, S., Ramírez, F., Echeverri, L. M., Peñata, A., & Ospina, S. (2015). Xpert MTB/RIF test performance assay in respiratory samples at real work settings in a developing country. Biomédica, 35(1), 125-130.

Bertolozzi, M. R., Takahashi, R. F., Hino, P., Litvoc, M., & França, F. O. S. (2014). O controle da tuberculose: um desafio para a saúde pública. Revista de Medicina, 93(2), 83-89.

Bunsow, E., Ruiz-Serrano, M. J., Roa, P. L., Kestler, M., Viedma, D. G., & Bouza, E. (2014). Avaliação do GeneXpert MTB/RIF para a detecção de Mycobacterium tuberculosis e resistência à rifampicina em amostras clínicas. Journal of Infection, 68(4), 338-343.

Casela, M., Cerqueira, S. M. A., Casela, T. D. O., Pereira, M. A., Santos, S. Q. D., Pozo, F. A. D., Freire, S. M., & Matos, E. D. (2018). Teste rápido molecular para tuberculose: avaliação do impacto de seu uso na rotina em um hospital de referência. Jornal Brasileiro de Pneumologia, 44(2), 112-117.

Caulfield, A. J., & Wengenack, N. L. (2016). Diagnosis of active tuberculosis disease: From microscopy to molecular techniques. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases, 4(1), 33-43.

Cepheid. (2016). Xpert® MTB/RIF Package Insert. http://www.cepheid.com/manageddownloads/xpert-mtb-rif-english-package-insert-301-1404-rev-c.pdf

Che-Engku-Chik, C. E. N., Yusof, N. A., Abdullah, J., Othman, S. S., Said, M. H. M., & Wasoh, H. (2016). Detection of tuberculosis (TB) using gold standard method, direct sputum smears microscopy, PCR, qPCR and electrochemical DNA sensor: A mini review. Journal of Biochemistry, Microbiology and Biotechnology, 4(2), 16-21.

Durovni, B., Saraceni, V., Van Den Hof, S., Trajman, A., Cordeiro-Santos, M., Cavalcante, S., Menezes, A., & Cobelens, F. (2014). Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial. PLoS Med, 11(12), e1001766.

Fonseca, J. D., Knight, G. M., & McHugh, T. D. (2015). The complex evolution of antibiotic resistance in Mycobacterium tuberculosis. International Journal of Infectious Diseases, 32(1), 94-100.

García, P., Balcells, M. E., Castillo, C., Miranda, C., Geoffroy, E., Román, J. C., & Wozniak, A. (2017). Evaluación de la técnica Xpert® MTB/RIF para la detección de Mycobacterium tuberculosis complex en muestras extra-pulmonares. Revista Chilena de Infectología, 34(4), 333-339.

Garrido, M. S., Bührer-Sékula, S., Souza, A. B., Oliveira, G. P., Antunes, I. A., Mendes, J. M., Saraceni, V., Martinez-Espinosa, F. E., & Ramasawmy, R. (2015). Multidrug-resistant tuberculosis in the Amazonas State, Brazil, 2000–2011. The International Journal of Tuberculosis and Lung Disease, 19(5), 531-536.

Gómez, A. V., González-Martín, J., & García-Basteiro, A. L. (2017). Xpert® MTB/RIF: utilidad en el diagnóstico de la tuberculosis y de la resistencia a la rifampicina. Medicina Clínica, 149(9), 399-405.

Günther, G., Van Leth, F., Alexandru, S., Altet, N., Avsar, K., Bang, D., Barbuta, R., Bothamley, G., Ciobanu, A., Crudu, V., Davilovits, M., Dedicoat, M., Duarte, R., Gualano, G., Kunst, H., Lange, W., Leimane, V., Magis-Escurra, C., McLaughlin, A. M., Muylle, I., Polcová, V., Pontali, E., Popa, C., Rumetshofer, R., Skrahina, A., Solodovnikova, V., Spinu, V., Tiberi, S., Viiklepp, P., & Lange, C. (2015). Multidrug-resistant tuberculosis in Europe, 2010–2011. Emerging Infectious Diseases, 21(3), 409-416.

Iram, S., Zeenat, A., Hussain, S., Yusuf, N. W., & Aslam, M. (2015). Rapid diagnosis of tuberculosis using Xpert MTB/RIF assay - Report from a developing country. Pakistan Journal of Medical Sciences, 31(1), 105-110.

Jaimes, J. R., Chavez, J. G., Flores, Y. H., & Nakiche, T. C. (2018). Identificación de micobacterias en medio sólido mediante microscopía de fase invertida y tinción Ziehl-Neelsen. Revista Peruana de Medicina Experimental y Salud Pública, 35(2), 279-284.

Jha, R. K., Singh, V., Vijayasimha, M., & Chhetry, G. (2019). A comparative assessment of Petroff’s and n-acetyl-l-cysteine-sodium hydroxide method in the diagnosis of pulmonary tuberculosis. Journal of Drug Delivery and Therapeutics, 9(3-s), 425-429.

Kohli, M., Schiller, I., Dendukuri, N., Dheda, K., Denkinger, C. M., Schumacher, S. G., & Steingart, K. R. (2018). Xpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews, 8(1), CD012768.

Liu, R., Liang, Q., Shang, Y., Ma, Y., Wang, F., Dong, L., Huang, H., Gao, M., & Pang, Y. (2019). GeneXpert of stool versus gastric lavage fluid for the diagnosis of pulmonary tuberculosis in severely ill adults. Infection, 47(4), 611-616.

Maciel, E. L. N., Brotto, L. D. D. A., Sales, C. M. M., Zandonade, E., & Sant'Anna, C. C. (2010). Coleta de lavado gástrico para diagnóstico de tuberculose pulmonar infantil: revisão sistemática. Revista de Saúde Pública, 44(4), 735-742.

Metcalf, T., Soria, J., Montano, S. M., Ticona, E., Evans, C. A., Huaroto, L., Kasper, M., Ramos, E. S., Mori, N., Jittamala, P., Chotivanich, K., Chavez, I. F., Singhasivanon, P., Pukrittayakamee, S., & Zunt, J. R. (2018). Evaluation of the GeneXpert MTB/RIF in patients with presumptive tuberculous meningitis. PloS One, 13(6), e0198695.

Ministério da Saúde. (2021). Boletim epidemiológico, Tuberculose - 2021. Secretaria de Vigilância em Saúde, Departamento de Doenças de Condições Crônicas e Infecções Sexualmente Transmissíveis, Coordenação Geral de Vigilância das Doenças de Transmissão Respiratória de Condições Crônicas. https://www.gov.br/saude/pt-br/media/pdf/2021/marco/24/boletim-tuberculose-2021_24.03

Ministério da Saúde. (2019). Manual de recomendações para o controle da tuberculose no Brasil. Secretaria de Vigilância em Saúde, Departamento de Vigilância das Doenças Transmissíveis. http://bvsms.saude.gov.br/bvs/publicacoes/manual_recomendacoes_controle_tuberculose_brasil_2_ed.pdf

Ministério da Saúde. (2014). Nota Informativa nº 9, de 11 de dezembro de 2014 - Recomendações sobre o diagnóstico da tuberculose por meio do teste rápido molecular para tuberculose. Coordenação Geral do Programa Nacional de Controle da Tuberculose. https://www.saude.go.gov.br/images/imagens_migradas/upload/arquivos/2016-05/nota-informativa-n-09-teste-rapido-molecular-tb.pdf

Ministério da Saúde. (2013). Portaria nº 48, de 10 de setembro de 2013 - Torna pública a decisão de incorporar o Teste Xpert MTB/RIF para diagnóstico de casos novos de tuberculose e detecção de resistência à rifampicina no Sistema Único de Saúde – SUS. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. http://bvsms.saude.gov.br/bvs/saudelegis/sctie/2013/prt0048_10_09_2013.html

Oliveira, G. S., Castro, G. R., Lima, C., Silva, J. X., Naves, J. D. O. S., & Monteiro Filho, C. M. R. (2016). Identificação laboratorial de micobactérias em amostras respiratórias de pacientes com suspeita de tuberculose pulmonar no Laboratório Central de Saúde Pública do Distrito Federal (LACEN-DF). Journal of Health & Biological Sciences, 4(3), 187-192.

Pereira, A. S., Shitsuka, D. M., Parreira, F. J., & Shitsuka, R. (2018). Metodologia da Pesquisa Científica. Santa Maria, RS: UFSM, NTE. https://repositorio.ufsm.br/bitstream/handle/1/15824/Lic_Computacao_Metodologia-Pesquisa-Cientifica.pdf?sequence=1

Pereira, M. G. (1999). Epidemiologia: Teoria e Prática. Rio de Janeiro: Guanabara Koogan.

Rachow, A., Saathoff, E., Mtafya, B., Mapamba, D., Mangu, C., Rojas-Ponce, G., Ntinginya, N. E., Boeree, M., Heinrich, N., Gillespie, S. H., Hoelscher, M., & PanACEA-Consortium. (2018). The impact of repeated NALC/NaOH-decontamination on the performance of Xpert MTB/RIF assay. Tuberculosis, 110(1), 56-58.

Sahrin, M., Rahman, A., Uddin, M. K. M., Kabir, S. N., Kabir, S., Houpt, E., & Banu, S. (2018). Discordance in Xpert® MTB/RIF assay results among low bacterial load clinical specimens in Bangladesh. The International Journal of Tuberculosis and Lung Disease, 22(9), 1056-1062.

Samper, S., & González-Martin, J. (2018). Diagnóstico microbiológico de las infecciones causadas por el género Mycobacterium. Enfermedades Infecciosas y Microbiología Clínica, 36(2), 104-111.

Sharma, S. K., Kohli, M., Yadav, R. N., Chaubey, J., Bhasin, D., Sreenivas, V., Sharma, R., & Singh, B. K. (2015). Evaluating the diagnostic accuracy of Xpert MTB/RIF assay in pulmonary tuberculosis. PloS One, 10(10), e0141011.

Silva, D. R., Dalcolmo, M., Tiberi, S., Arbex, M. A., Munoz-Torrico, M., Duarte, R., D’Ambrosio, L., Visca, D., Rendon, A., Gaga, M., Zumla, A., & Migliori, G. B. (2018). Novos fármacos e fármacos repropostos para o tratamento da tuberculose multirresistente e extensivamente resistente. Jornal Brasileiro de Pneumologia, 44(2), 153-160.

Silva, T. M., Soares, V. M., Ramos, M. G., & Santos, A. (2019). Acurácia do teste rápido molecular para tuberculose em amostras de escarro, lavado broncoalveolar e aspirado traqueal obtidos de pacientes com suspeita de tuberculose pulmonar em um hospital de referência terciária. Jornal Brasileiro de Pneumologia, 45(2), e20170451.

Tadesse, M., Abebe, G., Bekele, A., Bezabih, M., Yilma, D., Apers, L., Jong, B. C., & Rigouts, L. (2019). Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a diagnostic evaluation study. Clinical Microbiology and Infection, 25(8), 1000-1005.

Theron, G., Venter, R., Calligaro, G., Smith, L., Limberis, J., Meldau, R., Chanda, D., Esmail, A., Peter, J., & Dheda, K. (2016). Xpert MTB/RIF results in patients with previous tuberculosis: can we distinguish true from false positive results?. Clinical Infectious Diseases, 62(8), 995-1001.

Theron, G., Venter, R., Smith, L., Esmail, A., Randall, P., Sood, V., Oelfese, S., Calligaro. G., Warren, R., & Dheda, K. (2018). False-positive Xpert MTB/RIF results in retested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. Journal of Clinical Microbiology, 56(3), e01696-17.

Vallejo, P., Rodríguez, J. C., Searle, A., & Farga, V. (2015). Ensayo Xpert MTB/RIF en el diagnóstico de tuberculosis. Revista Chilena de Enfermedades Respiratorias, 31(2), 127-131.

Walker, T. M., Kohl, T. A., Omar, S. V., Hedge, J., Elias, C. D. O., Bradley, P., Iqbal, Z., Feuerriegel, S., Niehaus, K. E., Wilson, D. J., Clifton, D. A., Kapatai, G., Clp, C. L., Bowden, R., Drobniewski, F. A., Allix-Béguec, C., Gaudin, C., Parkhill, J., Diel, R., Supply, P., Crook, D. W., Smith, E. G., Walker, S. A., Ismail, N., Niemannt, S., Petot, T. E. A., & Modernizing Medical Microbiology Informatics Group. (2015). Whole-genome sequencing for prediction of Mycobacterium tuberculosis drug susceptibility and resistance: a retrospective cohort study. The Lancet Infectious Diseases, 15(10), 1193-1202.

Wang, G., Wang, S., Jiang, G., Fu, Y., Shang, Y., & Huang, H. (2018). Incremental cost-effectiveness of the second Xpert MTB/RIF assay to detect Mycobacterium tuberculosis. Journal of Thoracic Disease, 10(3), 1689-1695.

World Health Organization. (2020). Global tuberculosis report 2020. https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131-eng.pdf

World Health Organization. (2013). Using the Xpert MTB/RIF assay to detect pulmonar and extrapulmonary tuberculosis and rifampicin resistance in adults and children. Expert Group Meeting Report. https://apps.who.int/iris/bitstream/handle/10665/112659/WHO_HTM_TB_2013.14_eng.pdf

Zawedde-Muyanja, S., Manabe, Y. C., Sewankambo, N. K., Nakiyingi, L., & Nakanjako, D. (2018). Xpert® MTB/RIF associated with improved treatment initiation among patients with smear-negative tuberculosis. The International Journal of Tuberculosis and Lung Disease, 22(12), 1475-1480.

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Published

24/06/2021

How to Cite

DIETZ, J. do C.; BORGES, M. S.; ALVES, S. L. de Ávila; DIAS, D. X. R.; MANRIQUE, E. J. C. Performance of the Xpert® MTB/RIF test in the laboratory detection of tuberculosis in pulmonary and extrapulmonary samples. Research, Society and Development, [S. l.], v. 10, n. 7, p. e36610716533, 2021. DOI: 10.33448/rsd-v10i7.16533. Disponível em: https://rsdjournal.org/index.php/rsd/article/view/16533. Acesso em: 24 apr. 2024.

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Vol. 10 No. 7

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Health Sciences

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Copyright (c) 2021 Jefferson do Carmo Dietz; Marielly Sousa Borges; Sueli Lemes de Ávila Alves; Disley Xavier Rodrigues Dias; Edna Joana Cláudio Manrique

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