Инфекция и иммунитет. 2022; 12: 78-84
Эффективность GeneXpert MTB/RIF в диагностике внелегочного туберкулеза в Марокко
https://doi.org/10.15789/2220-7619-POG-1695Аннотация
Туберкулез (ТБ), хроническое бактериальное заболевание, вызываемое Mycobacterium tuberculosis, обычно поражает легкие, но также может затрагивать и другие анатомические области (внелегочный туберкулез, ВЛТ). Для начала специфического эффективного лечения необходимо проведение быстрой диагностики. Хотя культивирование микобактерий остается золотым стандартом для диагностики ВЛТ, все больший интерес вызывают молекулярные методы. GeneXpert MTB/RIF — быстрый автоматизированный диагностический тест, который позволяет обнаруживать M. tuberculosis, а также мутации в «горячем участке» гена rpoB, связанные с устойчивостью к рифампицину. Настоящее исследование было выполнено для оценки эффективности теста GeneXpert MTB/RIF для диагностики внелегочного туберкулеза в сравнении со стандартным методом. Данное проспективное исследование было проведено на 304 клинических образцах, собранных у 192 пациентов, посещавших лабораторию микобактерий и туберкулеза Института Пастера в Марокко в период с 2016 по 2017 гг. Из 304 образцов 113 составляла плевральная жидкость, очищенная с использованием метода Петрова, а 191 образец биопсии (78 лимфатических узлов и 113 биопсий плевры), деконтаминированные с использованием метода Левейнштейна. Обнаружение и идентификацию Mycobacterium tuberculosis проводили для всех образцов с использованием микроскопии мазка, культивирования на среде Левенштейна–Йенсена и теста GeneXpert MTB/RIF. Наши результаты показали, что 54,5% (103/189) составляли мужчины и 45,5% (86/189) — женщины. Возраст пациентов составлял от 2 до 78 лет, большинство пациентов были в возрастной группе от 25 до 45 лет. Внелегочные образцы были взяты из лимфатических узлов, плевральной жидкости и плевральных тканей с процентным соотношением 25,66, 37,17 и 37,17% соответственно. Интересно, что чувствительность GeneXpert составила 51,4% для всех образцов и 83,3% для лимфатических узлов. Таким образом, настоящее исследование показало, что эффективность теста GeneXpert значительно зависит от типа образца, при этом высокая чувствительность наблюдается для лимфатических узлов. Кроме того, мы показали, что тест GeneXpert MTB/RIF имеет ограничения в диагностике плеврального туберкулеза. Мы рекомендуем совместное использование GeneXpert MTB/RIF и традиционных методов для диагностики внелегочного туберкулеза.
Список литературы
1. Bennani K., Khattabi A., Akrim M., Mahtar M., Benmansour N., Essakalli Hossyni L., Karkouri M., Cherradi N., El Messaoudi M.D., Lahlou O., Cherkaoui I., Khader Y., Maaroufi A., Ottmani S.E. Evaluation of the yield of histopathology in the diagnosis of lymph node tuberculosis in Morocco, 2017. JMIR Public Health Surveill., 2019, vol. 5, no. 4: e14252. doi: 10.2196/14252
2. Christopher D.J., Schumacher S.G., Michael J.S., Luo R., Balamugesh T., Duraikannan P., Pollock N.R., Pai M., Denkinger C.M. Performance of Xpert MTB/RIF on pleural tissue for the diagnosis of pleural tuberculosis. Eur. Respir. J., 2013, vol. 42, no. 5, pp. 1427–1429. doi: 10.1183/09031936.00103213
3. Du J., Huang Z., Luo Q., Xiong G., Xu X., Li W., Liu X., Li J. Rapid diagnosis of pleural tuberculosis by Xpert MTB/RIF assay using pleural biopsy and pleural fluid specimens. J. Res. Med. Sci., 2015, vol. 20, no. 1, pp. 26–31.
4. Friedrich S.O., von Groote-Bidlingmaier F., Diacon A.H. Xpert MTB/RIF assay for diagnosis of pleural tuberculosis. J. Clin. Microbiol., 2011, vol. 49, no. 12, pp. 4341–4342. doi: 10.1128/JCM.05454-11
5. Ghariani A., Jaouadi T., Smaoui S., Mehiri E., Marouane C., Kammoun S., Essalah L., Driss M., Messadi F., Slim-Saidi L. Diagnosis of lymph node tuberculosis using the GeneXpert MTB/RIF in Tunisia. Int. J. Mycobacteriol., 2015, vol. 4, no. 4, pp. 270–275. doi: 10.1016/j.ijmyco.2015.05.011
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8. Ketata W., Rekik W.K., Ayadi H., Kammoun S. Les tuberculoses extrapulmonaires. Rev. Pneumol. Clin., 2015, vol. 71, no. 2–3, pp. 83–92. doi: 10.1016/j.pneumo.2014.04.001
9. Lawn S.D., Zumla A.I. Diagnosis of extrapulmonary tuberculosis using the Xpert® MTB/RIF assay. Expert Rev. Anti. Infect. Ther., 2012, vol. 10, no. 6, pp. 631–635. doi: 10.1586/eri.12.43
10. Le Ministre de la santé du Maroc. Ensemble pour un Maroc sans tuberculose, 2018. URL: https://www.sante.gov.ma/Pages/Communiques.aspx?IDCom=277
11. Lu Y., Zhu Y., Shen N., Tian L, Sun Z. Evaluating the diagnostic accuracy of the Xpert MTB/RIF assay on bronchoalveolar lavage fluid: a retrospective study. Int. J. Infect. Dis., 2018, vol. 71, pp. 14–19. doi: 10.1016/j.ijid.2018.01.030
12. Marouane C., Smaoui S., Kammoun S., Slim L., Messadi-Akrout F. Evaluation of molecular detection of extrapulmonary tuberculosis and resistance to rifampicin with GeneXpert® MTB/RIF. Med. Mal. Infect., 2016, vol. 46, no. 1, pp. 20–24. doi: 10.1016/j.medmal.2015.10.012
13. Marrakchi C., Maâloul I., Lahiani D., Hammami B., Boudawara T., Zribi M., Ben Jemaâ M. Diagnostic de la tuberculose ganglionnaire périphérique en Tunisie. Méd. Mal. Infect., 2010, vol. 40, no. 2, pp. 119–122. doi: 10.1016/j.medmal.2009.10.014
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. Evaluation of GeneXpert MTB/RIF System performances in the diagnosis of extrapulmonary tuberculosis. BMC Infect. Dis., 2019, vol. 19, no. 1: 1069. doi: 10.1186/s12879-019-4687-7
15. Moure R., Martin R., Alcaide F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J. Clin. Microbiol., 2012, vol. 50, no. 2, pp. 513–515. doi: 10.1128/JCM.06467-11
16. Naveen P., Nirmal C.K., Balbir M., Kuldip K. Role of geneXpert MTB/RIF in diagnosis of extrampulmonary tuberculosis at Gouvernment Medical College, Amritsar. Int. J. Curr. Res. Med. Sci., 2018, vol. 4, no. 3, pp. 134–141. doi: 10.22192/ijcrms.2018.04.03.017
17. Nicol M.P., Whitelaw A., Wendy S. Using Xpert MTB/RIF. Curr. Respir. Med. Rev., 2013, vol. 9, no. 3, pp. 187–192. doi: 10.2174/1573398X113099990015
18. Peirse M., Houston A. Extrapulmonary tuberculosis. Medicine, 2017, vol. 45, no. 12, pp. 747–752. doi: 10.1016/j.mpmed.2017.09.008
19. Porcel J.M., Palma R., Valdés L., Bielsa S., San-José E., Esquerda A. Xpert® MTB/RIF in pleural fluid for the diagnosis of tuberculosis. Int. J. Tuberc. Lung Dis., 2013, vol. 17, no. 9, pp. 1217–1219. doi: 10.5588/ijtld.13.0178
20. Rakotoarivelo R., Ambrosioni J., Rasolofo V., Raberahona M., Rakotosamimanana N., Andrianasolo R., Ramanampamonjy R., Tiaray M., Razafimahefa J., Rakotoson J., Randria M., Bonnet F., Calmy A.; MadaXpert Study Group. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. Int. J. Infect. Dis., 2018, vol. 69, pp. 20–25. doi: 10.1016/j.ijid.2018.01.017
21. Sharma B. Polyfunctional T cells as biomarkers in diagnosis of extrapulmonary tuberculosis. Respir. Med., 2017, vol. 5, no. 1, 2 p.
22. Tortoli E., Russo C., Piersimoni C., Mazzola E., Dal Monte P., Pascarella M., Borroni E., Mondo A., Piana F., Scarparo C., Coltella L., Lombardi G., Cirillo D.M. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. Eur. Respir. J., 2012, vol. 40, no. 2, pp. 442–447. doi: 10.1183/09031936.00176311
23. Tripathi K., Tripathi P.C., Nema S., Shrivastava A.K., Dwiwedi K., Dhanvijay A.K. Modified Petroff’s Method: an excellent simplified decontamination technique in comparison with Petroff’s method, IJRTSAT, 2014, vol. 10, no. 3, pp. 461–464.
24. WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Geneva: WHO, 2013. URL: https://pubmed.ncbi.nlm.nih.gov/25473701
25. WHO. Global tuberculosis report, 2019. Geneva: WHO, 2019, pp. 88–92.
26. Wright C.A., van der Burg M., Geiger D., Noordzij J.G., Burgess S.M., Marais B.J. Diagnosing mycobacterial lymphadenitis in children using fine needle aspiration biopsy: Cytomorphology, ZN staining and autofluorescence — making more of less. Diagn. Cytopathol., 2008, vol. 36, no. 4, pp. 245–251. doi: 10.1002/dc.20788
27. Zeka A.N., Tasbakan S., Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in pulmonary and extrapulmonary specimens. J. Clin. Microbiol., 2011, vol. 49, no. 12, pp. 4138– 4141. doi: 10.1128/JCM.05434-11
Russian Journal of Infection and Immunity. 2022; 12: 78-84
Performance of GeneXpert MTB/RIF in the diagnosis of extrapulmonary tuberculosis in Morocco
https://doi.org/10.15789/2220-7619-POG-1695Abstract
Tuberculosis (TB), a chronic bacterial disease caused by Mycobacterium tuberculosis, commonly affects the lung but can also affect other parts of the body (extrapulmonary tuberculosis, EPT). A rapid diagnosis is essential to initiate a specific and effective treatment. Although mycobacterial culture remains the gold standard for EPT diagnosis, molecular tools are attracting increasing interest. GeneXpert MTB/RIF, a rapid automated diagnostic test, allows the detection of Mycobacterium tuberculosis as well as mutations in the hot-spot region of the rpoB gene associated with Rifampicin resistance. The present study was performed to evaluate the performance of the GeneXpert MTB/RIF test for the diagnosis of EPT compared to the standard method. This prospective study was conducted on 304 clinical samples collected from 192 patients attending the Laboratory of Mycobacteria and Tuberculosis of Pasteur Institute of Morocco, between 2016 and 2017. Out of the 304 samples, 113 were pleural f luids decontaminated using the Petroff method and 191 were biopsies (78 lymph nodes and 113 pleural biopsies) decontaminated using the Löwenstein method. Mycobacterium tuberculosis detection and identification were performed on all samples using smear microscopy, Löwenstein–Jensen medium culture and the GeneXpert MTB/RIF test. Our results showed that 54.5 (103/189) were men and 45.5% (86/189) were women. The age of patients ranged from 2–78 years and the majority of patients was in the age group 25–45 years. Extrapulmonary samples were derived from lymph nodes, pleural f luids and pleural tissues, with a percentage of 25.66, 37.17 and 37.17%, respectively. Interestingly, the sensitivity of the GeneXpert was 51.4 for all samples and 83.3% for lymph nodes. In conclusion, the present study revealed that the performance of the GeneXpert test depends highly on the type of sample, with a high sensitivity observed for lymph nodes. Additionally, we clearly showed that the GeneXpert MTB/RIF test presents limitations in the diagnosis of pleural TB. Thus, we recommend the coupled use of the GeneXpert MTB/RIF and the conventional techniques for EPT diagnosis.
References
1. Bennani K., Khattabi A., Akrim M., Mahtar M., Benmansour N., Essakalli Hossyni L., Karkouri M., Cherradi N., El Messaoudi M.D., Lahlou O., Cherkaoui I., Khader Y., Maaroufi A., Ottmani S.E. Evaluation of the yield of histopathology in the diagnosis of lymph node tuberculosis in Morocco, 2017. JMIR Public Health Surveill., 2019, vol. 5, no. 4: e14252. doi: 10.2196/14252
2. Christopher D.J., Schumacher S.G., Michael J.S., Luo R., Balamugesh T., Duraikannan P., Pollock N.R., Pai M., Denkinger C.M. Performance of Xpert MTB/RIF on pleural tissue for the diagnosis of pleural tuberculosis. Eur. Respir. J., 2013, vol. 42, no. 5, pp. 1427–1429. doi: 10.1183/09031936.00103213
3. Du J., Huang Z., Luo Q., Xiong G., Xu X., Li W., Liu X., Li J. Rapid diagnosis of pleural tuberculosis by Xpert MTB/RIF assay using pleural biopsy and pleural fluid specimens. J. Res. Med. Sci., 2015, vol. 20, no. 1, pp. 26–31.
4. Friedrich S.O., von Groote-Bidlingmaier F., Diacon A.H. Xpert MTB/RIF assay for diagnosis of pleural tuberculosis. J. Clin. Microbiol., 2011, vol. 49, no. 12, pp. 4341–4342. doi: 10.1128/JCM.05454-11
5. Ghariani A., Jaouadi T., Smaoui S., Mehiri E., Marouane C., Kammoun S., Essalah L., Driss M., Messadi F., Slim-Saidi L. Diagnosis of lymph node tuberculosis using the GeneXpert MTB/RIF in Tunisia. Int. J. Mycobacteriol., 2015, vol. 4, no. 4, pp. 270–275. doi: 10.1016/j.ijmyco.2015.05.011
6. GLI. GLI model TB diagnostic algorithms. 2018. 37 p. URL: http://www.stoptb.org/wg/gli/assets/documents/gli_algorithms.pdf
7. Hamzaoui G., Amro L., Sajiai H., Serhane H., Moumen N., Ennezari A., Yazidi A.A. Tuberculose ganglionnaire: aspects épidémiologiques, diagnostiques et thérapeutiques, à propos de 357 cas. Pan Afr. Med. J., 2014, vol. 19: 157. doi: 10.11604/pamj.2014.19.157.4916
8. Ketata W., Rekik W.K., Ayadi H., Kammoun S. Les tuberculoses extrapulmonaires. Rev. Pneumol. Clin., 2015, vol. 71, no. 2–3, pp. 83–92. doi: 10.1016/j.pneumo.2014.04.001
9. Lawn S.D., Zumla A.I. Diagnosis of extrapulmonary tuberculosis using the Xpert® MTB/RIF assay. Expert Rev. Anti. Infect. Ther., 2012, vol. 10, no. 6, pp. 631–635. doi: 10.1586/eri.12.43
10. Le Ministre de la santé du Maroc. Ensemble pour un Maroc sans tuberculose, 2018. URL: https://www.sante.gov.ma/Pages/Communiques.aspx?IDCom=277
11. Lu Y., Zhu Y., Shen N., Tian L, Sun Z. Evaluating the diagnostic accuracy of the Xpert MTB/RIF assay on bronchoalveolar lavage fluid: a retrospective study. Int. J. Infect. Dis., 2018, vol. 71, pp. 14–19. doi: 10.1016/j.ijid.2018.01.030
12. Marouane C., Smaoui S., Kammoun S., Slim L., Messadi-Akrout F. Evaluation of molecular detection of extrapulmonary tuberculosis and resistance to rifampicin with GeneXpert® MTB/RIF. Med. Mal. Infect., 2016, vol. 46, no. 1, pp. 20–24. doi: 10.1016/j.medmal.2015.10.012
13. Marrakchi C., Maâloul I., Lahiani D., Hammami B., Boudawara T., Zribi M., Ben Jemaâ M. Diagnostic de la tuberculose ganglionnaire périphérique en Tunisie. Méd. Mal. Infect., 2010, vol. 40, no. 2, pp. 119–122. doi: 10.1016/j.medmal.2009.10.014
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. Evaluation of GeneXpert MTB/RIF System performances in the diagnosis of extrapulmonary tuberculosis. BMC Infect. Dis., 2019, vol. 19, no. 1: 1069. doi: 10.1186/s12879-019-4687-7
15. Moure R., Martin R., Alcaide F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. J. Clin. Microbiol., 2012, vol. 50, no. 2, pp. 513–515. doi: 10.1128/JCM.06467-11
16. Naveen P., Nirmal C.K., Balbir M., Kuldip K. Role of geneXpert MTB/RIF in diagnosis of extrampulmonary tuberculosis at Gouvernment Medical College, Amritsar. Int. J. Curr. Res. Med. Sci., 2018, vol. 4, no. 3, pp. 134–141. doi: 10.22192/ijcrms.2018.04.03.017
17. Nicol M.P., Whitelaw A., Wendy S. Using Xpert MTB/RIF. Curr. Respir. Med. Rev., 2013, vol. 9, no. 3, pp. 187–192. doi: 10.2174/1573398X113099990015
18. Peirse M., Houston A. Extrapulmonary tuberculosis. Medicine, 2017, vol. 45, no. 12, pp. 747–752. doi: 10.1016/j.mpmed.2017.09.008
19. Porcel J.M., Palma R., Valdés L., Bielsa S., San-José E., Esquerda A. Xpert® MTB/RIF in pleural fluid for the diagnosis of tuberculosis. Int. J. Tuberc. Lung Dis., 2013, vol. 17, no. 9, pp. 1217–1219. doi: 10.5588/ijtld.13.0178
20. Rakotoarivelo R., Ambrosioni J., Rasolofo V., Raberahona M., Rakotosamimanana N., Andrianasolo R., Ramanampamonjy R., Tiaray M., Razafimahefa J., Rakotoson J., Randria M., Bonnet F., Calmy A.; MadaXpert Study Group. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. Int. J. Infect. Dis., 2018, vol. 69, pp. 20–25. doi: 10.1016/j.ijid.2018.01.017
21. Sharma B. Polyfunctional T cells as biomarkers in diagnosis of extrapulmonary tuberculosis. Respir. Med., 2017, vol. 5, no. 1, 2 p.
22. Tortoli E., Russo C., Piersimoni C., Mazzola E., Dal Monte P., Pascarella M., Borroni E., Mondo A., Piana F., Scarparo C., Coltella L., Lombardi G., Cirillo D.M. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. Eur. Respir. J., 2012, vol. 40, no. 2, pp. 442–447. doi: 10.1183/09031936.00176311
23. Tripathi K., Tripathi P.C., Nema S., Shrivastava A.K., Dwiwedi K., Dhanvijay A.K. Modified Petroff’s Method: an excellent simplified decontamination technique in comparison with Petroff’s method, IJRTSAT, 2014, vol. 10, no. 3, pp. 461–464.
24. WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Geneva: WHO, 2013. URL: https://pubmed.ncbi.nlm.nih.gov/25473701
25. WHO. Global tuberculosis report, 2019. Geneva: WHO, 2019, pp. 88–92.
26. Wright C.A., van der Burg M., Geiger D., Noordzij J.G., Burgess S.M., Marais B.J. Diagnosing mycobacterial lymphadenitis in children using fine needle aspiration biopsy: Cytomorphology, ZN staining and autofluorescence — making more of less. Diagn. Cytopathol., 2008, vol. 36, no. 4, pp. 245–251. doi: 10.1002/dc.20788
27. Zeka A.N., Tasbakan S., Cavusoglu C. Evaluation of the GeneXpert MTB/RIF assay for rapid diagnosis of tuberculosis and detection of rifampin resistance in pulmonary and extrapulmonary specimens. J. Clin. Microbiol., 2011, vol. 49, no. 12, pp. 4138– 4141. doi: 10.1128/JCM.05434-11
