Application value of GeneXpert <i>Mycobacterium tuberculosis</i> / rifampin in urine samples for tuberculosis diagnosis_West China Medical Journal

Authors：

CHEN Yi , ZHAO Zhenzhen , SONG Xingbo ,  YING Binwu

Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

YING Binwu, Email: yingbinwu@scu.edu.cn

Keywords：

Tuberculosis; urinary system; urine; GeneXpert Mycobacterium tuberculosis / rifampin; diagnostic value

DOI：

10.7507/1002-0179.202307063

Video：

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Objective To investigate the clinical application value of GeneXpert Mycobacterium tuberculosis (MTB)/ rifampin (RIF) in urine samples for tuberculosis diagnosis. Methods The patients with clinically highly suspected tuberculosis admitted to West China Hospital of Sichuan University between January 1, 2018 and June 1, 2023 were selected retrospectively. The diagnostic efficacy of urine GeneXpert MTB/RIF detection, such as sensitivity, specificity, positive predictive value, and negative predictive value, were retrospectively analyzed to evaluate its clinical value in the diagnosis of tuberculosis. Correlation analysis was further conducted to explore the correlation between positive levels of GeneXpert MTB/RIF in urine samples and laboratory test indicators. Results A total of 400 patients were included. Among them, 163 cases were in the clinical tuberculosis group and 237 cases were in the clinical non tuberculosis group. In the clinical tuberculosis group, 112 cases were urogenital tuberculosis patients and 51 cases were non-urogenital tuberculosis patients. The sensitivity, specificity, positive predictive value, and negative predictive value of urine GeneXpert MTB/RIF in the diagnosis of tuberculosis were 55.2%, 97.5%, 93.8% and 76.0%, respectively. The sensitivity, specificity, positive predictive value, and negative predictive value of urine GeneXpert MTB/RIF in the diagnosis of urogenital tuberculosis were 65.2%, 92.0%, 76.0% and 87.2%, respectively, and the diagnostic sensitivity was further improved. Correlation analysis showed that the positive degree of urine GeneXpert MTB/RIF was correlated with the levels of hemoglobin, serum total protein, blood serum albumin, and other indicators. Conclusions Urine GeneXpert MTB/RIF detection offers high sensitivity and specificity in the diagnosis of tuberculosis, especially in urogenital tuberculosis, which is helpful for the early and rapid diagnosis of tuberculosis patients. The positive degree reported by the GeneXpert MTB/RIF in urine may indicate disease severity.

Citation： CHEN Yi, ZHAO Zhenzhen, SONG Xingbo, YING Binwu. Application value of GeneXpert Mycobacterium tuberculosis / rifampin in urine samples for tuberculosis diagnosis. West China Medical Journal, 2023, 38(8): 1133-1141. doi: 10.7507/1002-0179.202307063 Copy

1.	卓文基, 张晨晨, 陈珣珣, 等. 2014—2020 年广东省儿童肺结核耐药特征分析. 中国防痨杂志, 2023, 45(7): 687-692.
2.	Helb D, Jones M, Story E, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol, 2010, 48(1): 229-237.
3.	Chakravorty S, Simmons AM, Rowneki M, et al. The new Xpert MTB/RIF ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio, 2017, 8(4): e00812-17.
4.	World Health Organization. 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: policy update. Geneva: World Health Organization, 2013.
5.	Dorman SE, Schumacher SG, Alland D, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis, 2018, 18(1): 76-84.
6.	Kohli M, Schiller I, Dendukuri N, et al. Xpert^® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database Syst Rev, 2018(8): CD012768.
7.	Tortoli E, Russo C, Piersimoni C, et al. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. Eur Respir J, 2012, 40(2): 442-447.
8.	陈禹, 刘旭晖, 付亮, 等. GeneXpert MTB/RIF 在 HIV 阴性泌尿系结核中的诊断价值. 中国防痨杂志, 2017, 39(10): 1100-1106.
9.	吴硕, 袁通, 邹绍祺, 等. 3 种方法诊断泌尿生殖系统结核感染的诊断价值分析. 潍坊医学院学报, 2023, 45(3): 161-168.
10.	中华人民共和国国家卫生和计划生育委员会. 肺结核诊断标准 (WS 288—2017). 新发传染病电子杂志, 2018, 3(1): 59-61.
11.	中华人民共和国国家卫生和计划生育委员会. 结核病分类(WS196—2017). 新发传染病电子杂志, 2018, 3(3): 191-192.
12.	Peter JG, Theron G, Muchinga TE, et al. The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalized patients who are smear-negative or sputum scarce. PLoS One, 2012, 7(7): e39966.
13.	Pang Y, Shang Y, Lu J, et al. GeneXpert MTB/RIF assay in the diagnosis of urinary tuberculosis from urine specimens. Sci Rep, 2017, 7(1): 6181.
14.	赵雁林, 逄宇. 结核病实验室检验规程. 北京: 人民卫生出版社, 2015.
15.	Deggim V, Somoskovi A, Voit A, et al. Integrating the Xpert MTB/RIF assay into a diagnostic workflow for rapid detection of Mycobacterium tuberculosis in a low-prevalence area. J Clin Microbiol, 2013, 51(7): 2396-2399.
16.	Rufai SB, Singh A, Singh J, et al. Diagnostic usefulness of Xpert MTB/RIF assay for detection of tuberculous meningitis using cerebrospinal fluid. J Infect, 2017, 75(2): 125-131.
17.	Cresswell FV, Tugume L, Bahr NC, et al. Xpert MTB/RIF Ultra for the diagnosis of HIV-associated tuberculous meningitis: a prospective validation study. Lancet Infect Dis, 2020, 20(3): 308-317.
18.	Ghariani A, Jaouadi T, Smaoui S, et al. Diagnosis of lymph node tuberculosis using the GeneXpert MTB/RIF in Tunisia. Int J Mycobacteriol, 2015, 4(4): 270-275.
19.	Huang S, Qin M, Shang Y, et al. Performance of Xpert MTB/RIF in diagnosis of lymphatic tuberculosis from fresh and formaldehyde-fixed and paraffin embedded lymph nodes. Tuberculosis (Edinb), 2020, 124: 101967.
20.	Chen HK, Liu RS, Wang YX, et al. Xpert MTB/RIF assay for the diagnosis of lymph node tuberculosis in children: a systematic review and meta-analysis. J Clin Med, 2022, 11(15): 4616.
21.	苏丹, 车南颖, 欧喜超, 等. 不同细菌学与病理学检查技术对骨关节结核诊断的效能研究. 中国防痨杂志, 2022, 44(4): 362-367.
22.	Gu Y, Wang G, Dong W, et al. Xpert MTB/RIF and GenoType MTBDRplus assays for the rapid diagnosis of bone and joint tuberculosis. Int J Infect Dis, 2015, 36: 27-30.
23.	Yu X, Wang F, Ren R, et al. Xpert MTB/RIF ultra assay using stool: an effective solution for bacilli identification from adult pulmonary tuberculosis suspects without expectorated sputum. Microbiol Spectr, 2023: e0126523.
24.	Prihadi JC, Putra AC, Wahyudi Y. Biopsy-confirmed genitourinary tuberculosis in a secondary health care hospital: an evidence-based clinical review. Res Rep Urol, 2021, 13: 133-137.
25.	李静, 赵涛, 梁亚萍, 等. MGIT 960 培养联合 GeneXpert MTB/RIF 检测在泌尿系结核诊断中的价值. 陕西医学杂志, 2021, 50(11): 1441-1445.
26.	Liu P, Wang Y, Hao S, et al. Comparison of the CapitalBio^TM mycobacterium RT-PCR detection test and Xpert MTB/RIF assay for diagnosis of renal tuberculosis. Eur J Clin Microbiol Infect Dis, 2021, 40(3): 559-563.
27.	van Vollenhoven P, Heyns CF, de Beer PM, et al. Polymerase chain reaction in the diagnosis of urinary tract tuberculosis. Urol Res, 1996, 24(2): 107-111.
28.	Lawn SD, Mwaba P, Bates M, et al. Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test. Lancet Infect Dis, 2013, 13(4): 349-361.
29.	Tadesse M, Abebe G, Bekele A, et al. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a diagnostic evaluation study. Clin Microbiol Infect, 2019, 25(8): 1000-1005.
30.	Denkinger CM, Schumacher SG, Boehme CC, et al. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis. Eur Respir J, 2014, 44(2): 435-446.
31.	Minnies S, Reeve BWP, Rockman L, et al. Xpert MTB/RIF ultra is highly sensitive for the diagnosis of tuberculosis lymphadenitis in a high-HIV Setting. J Clin Microbiol, 2021, 59(12): e0131621.
32.	Martyn EM, Bangdiwala AS, Kagimu E, et al. Cerebrospinal fluid bacillary load by Xpert MTB/RIF ultra polymerase chain reaction cycle threshold value predicts 2-week mortality in human immunodeficiency virus-associated tuberculous meningitis. Clin Infect Dis, 2021, 73(9): e3505-e3510.
33.	罗小青, 段思雨, 林铭钰, 等. 结核病并发糖尿病住院患者的营养风险及其影响因素. 中国防痨杂志, 2021, 43(1): 42-46.
34.	周伊南, 朱惠莉. 慢性阻塞性肺疾病合并肺结核的研究进展. 结核与肺部疾病杂志, 2022, 3(4): 338-342.
35.	王红红, 郭少晨, 周文强, 等. 耐药结核病患者利奈唑胺血药浓度对血液系统毒性发生的影响. 中国防痨杂志, 2023, 45(2): 165-171.

1. 卓文基, 张晨晨, 陈珣珣, 等. 2014—2020 年广东省儿童肺结核耐药特征分析. 中国防痨杂志, 2023, 45(7): 687-692.
2. Helb D, Jones M, Story E, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. J Clin Microbiol, 2010, 48(1): 229-237.
3. Chakravorty S, Simmons AM, Rowneki M, et al. The new Xpert MTB/RIF ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio, 2017, 8(4): e00812-17.
4. World Health Organization. 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: policy update. Geneva: World Health Organization, 2013.
5. Dorman SE, Schumacher SG, Alland D, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis, 2018, 18(1): 76-84.
6. Kohli M, Schiller I, Dendukuri N, et al. Xpert^® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance. Cochrane Database Syst Rev, 2018(8): CD012768.
7. Tortoli E, Russo C, Piersimoni C, et al. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. Eur Respir J, 2012, 40(2): 442-447.
8. 陈禹, 刘旭晖, 付亮, 等. GeneXpert MTB/RIF 在 HIV 阴性泌尿系结核中的诊断价值. 中国防痨杂志, 2017, 39(10): 1100-1106.
9. 吴硕, 袁通, 邹绍祺, 等. 3 种方法诊断泌尿生殖系统结核感染的诊断价值分析. 潍坊医学院学报, 2023, 45(3): 161-168.
10. 中华人民共和国国家卫生和计划生育委员会. 肺结核诊断标准 (WS 288—2017). 新发传染病电子杂志, 2018, 3(1): 59-61.
11. 中华人民共和国国家卫生和计划生育委员会. 结核病分类(WS196—2017). 新发传染病电子杂志, 2018, 3(3): 191-192.
12. Peter JG, Theron G, Muchinga TE, et al. The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalized patients who are smear-negative or sputum scarce. PLoS One, 2012, 7(7): e39966.
13. Pang Y, Shang Y, Lu J, et al. GeneXpert MTB/RIF assay in the diagnosis of urinary tuberculosis from urine specimens. Sci Rep, 2017, 7(1): 6181.
14. 赵雁林, 逄宇. 结核病实验室检验规程. 北京: 人民卫生出版社, 2015.
15. Deggim V, Somoskovi A, Voit A, et al. Integrating the Xpert MTB/RIF assay into a diagnostic workflow for rapid detection of Mycobacterium tuberculosis in a low-prevalence area. J Clin Microbiol, 2013, 51(7): 2396-2399.
16. Rufai SB, Singh A, Singh J, et al. Diagnostic usefulness of Xpert MTB/RIF assay for detection of tuberculous meningitis using cerebrospinal fluid. J Infect, 2017, 75(2): 125-131.
17. Cresswell FV, Tugume L, Bahr NC, et al. Xpert MTB/RIF Ultra for the diagnosis of HIV-associated tuberculous meningitis: a prospective validation study. Lancet Infect Dis, 2020, 20(3): 308-317.
18. Ghariani A, Jaouadi T, Smaoui S, et al. Diagnosis of lymph node tuberculosis using the GeneXpert MTB/RIF in Tunisia. Int J Mycobacteriol, 2015, 4(4): 270-275.
19. Huang S, Qin M, Shang Y, et al. Performance of Xpert MTB/RIF in diagnosis of lymphatic tuberculosis from fresh and formaldehyde-fixed and paraffin embedded lymph nodes. Tuberculosis (Edinb), 2020, 124: 101967.
20. Chen HK, Liu RS, Wang YX, et al. Xpert MTB/RIF assay for the diagnosis of lymph node tuberculosis in children: a systematic review and meta-analysis. J Clin Med, 2022, 11(15): 4616.
21. 苏丹, 车南颖, 欧喜超, 等. 不同细菌学与病理学检查技术对骨关节结核诊断的效能研究. 中国防痨杂志, 2022, 44(4): 362-367.
22. Gu Y, Wang G, Dong W, et al. Xpert MTB/RIF and GenoType MTBDRplus assays for the rapid diagnosis of bone and joint tuberculosis. Int J Infect Dis, 2015, 36: 27-30.
23. Yu X, Wang F, Ren R, et al. Xpert MTB/RIF ultra assay using stool: an effective solution for bacilli identification from adult pulmonary tuberculosis suspects without expectorated sputum. Microbiol Spectr, 2023: e0126523.
24. Prihadi JC, Putra AC, Wahyudi Y. Biopsy-confirmed genitourinary tuberculosis in a secondary health care hospital: an evidence-based clinical review. Res Rep Urol, 2021, 13: 133-137.
25. 李静, 赵涛, 梁亚萍, 等. MGIT 960 培养联合 GeneXpert MTB/RIF 检测在泌尿系结核诊断中的价值. 陕西医学杂志, 2021, 50(11): 1441-1445.
26. Liu P, Wang Y, Hao S, et al. Comparison of the CapitalBio^TM mycobacterium RT-PCR detection test and Xpert MTB/RIF assay for diagnosis of renal tuberculosis. Eur J Clin Microbiol Infect Dis, 2021, 40(3): 559-563.
27. van Vollenhoven P, Heyns CF, de Beer PM, et al. Polymerase chain reaction in the diagnosis of urinary tract tuberculosis. Urol Res, 1996, 24(2): 107-111.
28. Lawn SD, Mwaba P, Bates M, et al. Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test. Lancet Infect Dis, 2013, 13(4): 349-361.
29. Tadesse M, Abebe G, Bekele A, et al. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a diagnostic evaluation study. Clin Microbiol Infect, 2019, 25(8): 1000-1005.
30. Denkinger CM, Schumacher SG, Boehme CC, et al. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis. Eur Respir J, 2014, 44(2): 435-446.
31. Minnies S, Reeve BWP, Rockman L, et al. Xpert MTB/RIF ultra is highly sensitive for the diagnosis of tuberculosis lymphadenitis in a high-HIV Setting. J Clin Microbiol, 2021, 59(12): e0131621.
32. Martyn EM, Bangdiwala AS, Kagimu E, et al. Cerebrospinal fluid bacillary load by Xpert MTB/RIF ultra polymerase chain reaction cycle threshold value predicts 2-week mortality in human immunodeficiency virus-associated tuberculous meningitis. Clin Infect Dis, 2021, 73(9): e3505-e3510.
33. 罗小青, 段思雨, 林铭钰, 等. 结核病并发糖尿病住院患者的营养风险及其影响因素. 中国防痨杂志, 2021, 43(1): 42-46.
34. 周伊南, 朱惠莉. 慢性阻塞性肺疾病合并肺结核的研究进展. 结核与肺部疾病杂志, 2022, 3(4): 338-342.
35. 王红红, 郭少晨, 周文强, 等. 耐药结核病患者利奈唑胺血药浓度对血液系统毒性发生的影响. 中国防痨杂志, 2023, 45(2): 165-171.

West China Medical Journal

Application value of GeneXpert Mycobacterium tuberculosis / rifampin in urine samples for tuberculosis diagnosis

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