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Journal of Peking University (Health Sciences) ›› 2021, Vol. 53 ›› Issue (2): 320-326. doi: 10.19723/j.issn.1671-167X.2021.02.015

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Accuracy of Xpert®MTB/RIF for the detection of tuberculosis and rifampicin-resistance tuberculosis in China: A systematic review and meta-analysis

FENG Jing-nan,GAO Le,SUN Yi-xin,YANG Ji-chun,DENG Si-wei,SUN Feng,ZHAN Si-yan()   

  1. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China
  • Received:2019-01-18 Online:2021-04-18 Published:2021-04-21
  • Contact: Si-yan ZHAN E-mail:siyan-zhan@bjmu.edu.cn

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Abstract:

Objective: To systematically review the diagnostic accuracy of Xpert® Mycobacterium tuberculosis/rifampicin (Xpert® MTB/RIF) for the detection of active tuberculosis (TB) and rifampicin-resistance TB in Chinese patients. Methods: Four Chinese databases (SinoMed, CNKI, WanFang database, and VIP) and three English databases (PubMed, Embase, and The Cochrane Library) were searched from January 1, 2000 to September 15, 2017, to identify diagnostic tests about the accuracy of Xpert® MTB/RIF in Chinese patients. Two investigators screened the articles and extracted the information independently, and then the quality of each included study was evaluated by Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2. Bivariate random-effects meta-analysis was conducted to pool the sensitivity and specificity. In addition, subgroup analyses were performed based on patient type (TB patient and TB suspected patient), sample type (sputum, bronchoalveolar lavage fluid and others). All statistical analyses were conducted with Stata version 13.0. Results: A total of 47 articles were included in this systematic review. Most of them (38 articles) were in Chinese and only 9 articles were in English. All the articles were published during 2014 to 2017, and the sample size ranged from 31 to 3 151. Forty articles including 42 comparisons about TB were finally included with the pooled sensitivity of 0.94 (95%CI: 0.92, 0.95) and the pooled specificity of 0.87 (95%CI: 0.84, 0.91). Subgroup analysis showed that different patient and specimen types had no significant differences on sensitivity, but the specificity of sputum group was higher than that of bronchoalveolar lavage fluid. As for the detection of rifampicin-resistant TB, 33 articles (38 comparisons) were analyzed, the pooled sensitivity and specificity were 0.92 (95%CI: 0.89, 0.94) and 0.98 (95%CI: 0.97, 0.99) respectively. There were no significant differences between the patient and specimen in the subgroup analyses. The Deeks funnel plot showed a possible publication bias for detecting active tuberculosis (P=0.08) and no publication bias for rifampicin-resistant TB (P=0.24). The likelihood ratio scatter gram showed that in clinical applications, Xpert® MTB/RIF had a good diagnostic ability for detecting active tuberculosis, and it had good clinical diagnostic value in detecting rifampicin-resistant TB. Conclusion: Xpert® MTB/RIF has good sensitivity and specificity in detecting TB and rifampicin-resistant TB in Chinese people. In particular, it has good clinical value in diagnosing rifampicin-resistance TB.

Key words: Pulmonary tuberculosis, Multidrug-resistant tuberculosis, Xpert®MTB/RIF, Meta-analysis

CLC Number: 

  • R181.2

Figure 1

Flow diagram showing study selection process TB, tuberculosis; MTB/RIF, Mycobacterium tuberculosis/rifampicin; DST, drug sensitivity test."

Figure 2

Quality assessment of included articles"

Table 1

Meta-analysis results and subgroups analysis"

Group Subgroups No. of studies No. of comparisons Pooled sensitivity (95%CI) Pooled specificity (95%CI) I2
Active tuberculosis
Total 40 42 0.94 (0.92, 0.95) 0.87 (0.84, 0.91) 99%
Patient TB suspected patient 21 21 0.92 (0.88, 0.94) 0.90 (0.86, 0.92) 98%
TB patient 18 20 0.95 (0.93, 0.97) 0.84 (0.75, 0.90) 98%
Both* 1 1 0.95 (0.92, 0.98) 0.95 (0.93, 0.97)
Specimen Sputum 33 35 0.93 (0.91, 0.95) 0.90 (0.87, 0.92) 98%
BALF 6 6 0.97 (0.93, 0.99) 0.68 (0.56, 0.78) 38%
Others* 1 1 0.65 (0.40, 0.83) 0.70 (0.63, 0.76)
Rifampicin-resistant tuberculosis
Total 33 38 0.92 (0.89, 0.94) 0.98 (0.97, 0.99) 72%
Patient TB suspected patient 17 22 0.90 (0.87, 0.93) 0.98 (0.97, 0.98) 35%
TB patient 13 13 0.91 (0.87, 0.95) 0.98 (0.96, 0.99) 73%
Both* 3 3 0.94 (0.87, 0.98) 0.98 (0.97, 0.99) Se: 18.6%, Sp: 0
Specimen Sputum 26 31 0.90 (0.88, 0.92) 0.98 (0.97, 0.99) 80%
BALF 3 3 0.87 (0.59, 0.97) 0.94 (0.87, 0.97) Se: 0, Sp: 0
Others* 4 4 0.98 (0.94, 1.00) 0.98 (0.96, 0.99) Se: 31.1%, Sp: 0

Figure 3

Results of publication bias tests A, active tuberculosis; B, rifampicin-resistant tuberculosis. ESS, effective sample size."

Figure 4

Likelihood ratio scatter gram A, active tuberculosis; B, rifampicin-resistant tuberculosis. LUQ, left upper quadrant; RUQ, right upper quadrant; LLQ, left lower quadrant; RLQ, right lower quadrant; LRP, positive likelihood ratio; LRN, negative likelihood ratio."

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