The diagnostic value of Xpert MTB/RIF detection in different types of samples of tuberculosis patients

doi:10.19871/j.cnki.xfcrbzz.2026.04.002

Abstract

Abstract: Objective This study aimed to evaluate the diagnostic performance of the GeneXpert Mycobacterium tuberculosis/rifampicin assay (Xpert MTB/RIF), a real-time fluorescent quantitative nucleic acid amplification test, in different clinical specimens from patients with active tuberculosis (TB), so as to provide evidence for specimen selection in clinical TB diagnosis. Method A retrospective analysis was performed. Clinical data and Xpert MTB/RIF test results of various specimens were collected from patients diagnosed with active TB at the Third People's Hospital of Shenzhen between January and December 2023. The positive detection rates across specimen types were statistically compared. Paired samples of bronchoalveolar lavage fluid (BALF) versus sputum, and tissue versus pus were analyzed for detection rate differences. The prevalence of rifampicin resistance was also compared between patients with newly treated TB and retreated TB. Result A total of 1,443 specimens were enrolled. The overall positive detection rate of Xpert MTB/RIF was 69.02% (996/1443). The positive rates of different specimens sorted in descending order were as follows: pus 89.11% (221/248), bronchoalveolar lavage fluid 84.50% (169/200), sputum 74.74% (361/483), tissue 71.42% (100/140), urine 56.96% (45/79), stool 42.86% (42/98), cerebrospinal fluid 34.14% (28/82), and pleural effusion 26.55% (30/113). Paired analysis for pulmonary TB patients revealed that the detection rate of BALF (87.90%, 109/124) was significantly higher than that of sputum (67.74%, 84/124), with a statistically significant difference (χ²=18.939,P<0.001). For extrapulmonary TB patients, the detection rate of pus (86.76%, 59/68) was markedly higher than that of tissue specimens (64.71%, 44/68) (χ²=9.000, P=0.002). Rifampicin resistance testing showed an overall resistance rate of 8.59% (124/1443), including a resistance rate of 2.84% in newly treated TB patients and 5.75% in retreated TB patients. Conclusion Xpert MTB/RIF assay features rapid detection, simple operation, high specificity, and the capability to identify rifampicin resistance. However, its diagnostic yield varies substantially by specimen type. Targeted selection of clinical specimens can effectively improve the etiological diagnostic accuracy of tuberculosis.

Key words: Xpert MTB/RIF, Tuberculosis, Molecular diagnosis, Rifampicin resistance, Diagnostic efficiency, Paired detection

CLC Number:

R446

Zhang Yaxi, Li Jing, Yang Qianting, Wang Min, Zhan Senlin, Chen Qi. The diagnostic value of Xpert MTB/RIF detection in different types of samples of tuberculosis patients[J]. Electronic Journal of Emerging Infectious Diseases, 2026, 11(4): 13-17.

References

[1] Kedige A R, Dinesh U S.Role of bronchoscopic cytology indiagnosis of pulmonary lesions[J]. J Cytol, 2023, 40(1):35-41.
[2] 杨松,郭建琼,唐神结, 等.结核病介入诊断与治疗年度进展2023[J].中华结核和呼吸杂志. 2024, 47(4):363-370.
[3] Ye J, Huang K, Xu Y.et al. Clinical application of nanopore-targeted sequencing technology in bronchoalveolar lavage fluid from patients with pulmonary infections[J]. Microbiol Spectr, 2024-06-04;12(6):e0002624.
[4] Kay A,Vasiliu A,Carratala-castro L. et al.Performance of a stool-based quantitative PCR assay for the diagnosis of tuberculosis in adolescents and adults: a multinational, prospective diagnostic accuracy study[J].Lancet Microbe, 2024, 5(5):e433-e441.
[5] Kumbi H, Ali M M, ABATE A.et al.Performance of fine needle aspiration cytology and Ziehl-Neelsen staining technique in the diagnosis of tuberculosis lymphadenitis[J]. BMC Infect Dis, 2024, 24(1):633.
[6] 中华人民共和国国家卫生和计划生育委员会. 肺结核诊断(WS 288-2017)[J/CD].新发传染病电子杂志,2018,3(1):59-61.
[7] Auld S C, Barczak A K, Bishai W, et al.Pathogenesis of Post-Tuberculosis Lung Disease: Defining Knowledge Gaps and Research Priorities at the Second International Post-Tuberculosis Symposium[J]. Am J Respir Crit Care Med, 2024, 210(8):979-993.
[8] Qadir M, Khan M T, Khan S A, et al.Unveiling the complexity of rifampicin drug susceptibility testing in Mycobacterium tuberculosis: comparative analysis with next-generation sequencing[J]. J Med Microbiol, 2024, 73(9).
[9] Cabibbe A M, Moghaddasi K, Batignani V.et al.Nanopore-based targeted sequencing test for direct tuberculosis identification, genotyping, and detection of drug resistance mutations: a side-by-side comparison of targeted next-generation sequencing technologies[J]. J Clin Microbiol, 2024, 62(10):e0081524.
[10] Van Stigt A C, Von Der Thüsen J H, Mustafa D A M, et al. Granulomas in Common Variable Immunodeficiency Display Different Histopathological Features Compared to Other Granulomatous Diseases[J]. J Clin Immunol, 2024, 45(1):22.
[11] Jung M K, Lee S Y, Min E J, et al.CT Scan Differences of Pulmonary TB According to Presence of Pleural Effusion[J]. Chest, 2023, 164(6):1387-1395.
[12] Ayers T, Hill A N, Raykin J, et al.Comparison of Tuberculin Skin Testing and Interferon-γ Release Assays in Predicting Tuberculosis Disease[J]. JAMA Netw Open, 2024, 7(4):e244769.
[13] Ho J, Nguyen P T B, Nguyen T A, et al.Reassessment of the positive predictive value and specificity of Xpert MTB/RIF:a diagnostic accuracy study in the context of community-wide screening for tuberculosis[J].Lancet Infect Dis, 2016, 16(9):1045-1051.
[14] 陈涛, 王玉香, 郑俊峰, 等. Xpert MTB/RIF在呼吸道标本检出极低值并利福平耐药时的诊断可靠性分析[J]. 新发传染病电子杂志, 2021, 6(4): 319-322.
[15] Ramachandran S, Pajanivel R.The Imperative Role of Xpert® Mycobacterium Tuberculosis Complex/Resistance to Rifampin (MTB/RIF) in Rapid Diagnosis of Pulmonary and Extrapulmonary Tuberculosis[J]. Cureus, 2024, 16(12): e76706.
[16] Qin L, Huo F, Ren W, et al.Dependence of Xpert MTB/RIF Accuracy for Detecting Rifampin Resistance in Bronchoalveolar Lavage Fluid on Bacterial Load: A Retrospective Study in Beijing, China[J]. Infect Drug Resist, 2021, 14:2429-2435.
[17] Goyal N, Kashyap B, Puneeta H, et al.Comparative Diagnostic Accuracy of Mean and Lowest Cycle Threshold Levels in Xpert MTB/RIF Assay and Molecular Epidemiology of Missing Probes In Rifampicin Resistant Tubercular Cases From A Tertiary Care Hospital[J]. Perspectives In Medical Research, 2022, 9(3): 58-63.
[18] Zong K, Luo C, Zhou H, et al.Xpert MTB/RIF assay for the diagnosis of rifampicin resistance in different regions: a meta-analysis[J]. BMC Microbiol, 2019, 19(1): 177.
[19] World Health Organization.WHO consolidated guidelines on tuberculosis rapid diagnostics for tuberculosis detection; Module 3: Diagnosis. 3rd ed[R]. Geneva: World Health Organization, 2024.
[20] Kohli M, Schiller I, Dendukuri N, et al. Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults[J]. Cochrane Database Syst Rev, 2021, 1(1):CD012768.
[21] Dudnyk A, Lutchmun W, Duarte R, et al.The importance of getting the dose right in the treatment of tuberculosis[J]. Breathe, 2025, 21(1): 240177.