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Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition) ›› 2025, Vol. 19 ›› Issue (06): 345-352. doi: 10.3877/cma.j.issn.1674-1358.2025.06.004

• Research Article • Previous Articles    

Consistency and influencing factors of gene Xpert Mycobacterium Tuberculosis/Rifampicin resistance assay and targeted metagenomic sequencing in the diagnosis of Mycobacterium tuberculosis infection

Hui Quan, Mengchao Hu, Xiaohui Lu, Rongrong Zhai()   

  1. Department of Medical Laboratory, Lu’an People’s Hospital, Lu’an 237005, China
  • Received:2025-04-28 Online:2025-12-15 Published:2026-02-12
  • Contact: Rongrong Zhai

Abstract:

Objective

To analyze the consistency of gene Xpert Mycobacterium Tuberculosis (MTB)/Rifampicin resistance assay (Xpert-MTB/RIF) and targeted metagenomic sequencing (tNGS) in detection of MTB, and to analyze the influencing factors of consistency differences.

Methods

The clinical data of 95 patients with suspected tuberculosis (TB) admitted to Lu’an People’s Hospital from October 2023 to May 2025 were analyzed, retrospectively. The consistency analysis was performed on MTB detection results from Xpert MTB/RIF and tNGS technologies, and the efficacy of the two methods in assisting TB diagnosis were analyzed by receiver operating characteristic (ROC) curves. The influencing factors of the consistency of Xpert MTB/RIF and tNGS detection results were analyzed by Logistic regression analysis. Cluster analysis was used to divide the enrolled patients into high-risk group (35 cases) and low-risk group (60 cases) based on different uric acid (UA) levels, and the differences in distribution characteristics of influencing factors of MTB detection consistency using Xpert MTB/RIF and tNGS technologies between the two groups were compared.

Results

According to the final clinical diagnostic criteria, there were 55 TB cases and 40 non-TB cases. ROC curve analysis showed that the area under the ROC curve (AUC) for Xpert MTB/RIF and tNGS in assisting TB diagnosis were 0.931 (0.834-0.983) and 0.941 (0.884-0.975), respectively. The sensitivity and specificity of Xpert MTB/RIF were 90.91% and 90.00%, while those of tNGS were 90.91% and 92.50%, respectively. Logistic regression analysis indicated that age≥54 years old (OR=1.154, 95%CI: 1.059-1.226, P=0.019), disease type was non-TB (OR=6.836, 95%CI: 1.813-25.776, P=0.005), specimen type was sputum (OR=7.215, 95%CI: 5.264-8.965, P=0.005), and UA≥435.52 µmol/L (OR=5.643, 95%CI: 2.565-8.643, P=0.005) were all independent risk factors affecting the diagnostic concordance between Xpert MTB/RIF and tNGS. The diagnostic concordance between the two methods was higher in TB patients than that of non-TB patients, and alveolar lavage fluid specimens showed higher diagnostic concordance than sputum specimens. In the high-risk group, the proportion of “fewer risk factors distribution” type was significantly lower than that in the low-risk group, with significant difference (χ2=10.887, P=0.023).

Conclusions

Xpert MTB/RIF and tNGS demonstrated good consistency in MTB detection, the consistency is significantly affected by age, disease type, sample type and uric acid level.

Key words: Real-time fluorescent quantitative nucleic acid amplification test for rifampicin-resistant Mycobacterium tuberculosis, Targeted metagenomic sequencing, Mycobacterium tuberculosis, Tuberculosis

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