Diagnostic accuracy of the Xpert® MTB/RIF assay for extra-pulmonary tuberculosis: a meta-analysis
Abstract
BACKGROUND: Xpert(®) MTB/RIF is a commercially available nucleic acid amplification test developed for the diagnosis of pulmonary tuberculosis (PTB). OBJECTIVE: To determine the diagnostic accuracy of Xpert for the detection of extra-pulmonary tuberculosis (EPTB). METHODS: We searched MEDLINE, EMBASE and Global Health databases from January 2010 to 15 August 2014 for studies of diagnostic performance in which Xpert was examined against culture for patients with clinically suspected EPTB. Bivariate random effects models were used to provide pooled estimates of diagnostic accuracy. RESULTS: Thirty-six studies were identified, with a pooled sensitivity and specificity of respectively 77% (95%CI 66-85) and 97% (95%CI 94-98). Substantial variations existed between study estimates of sensitivity (I(2) = 99%) and specificity (I(2) = 96%). Among site-specific estimates for lymph, pleural fluid, cerebrospinal fluid, gastro-intestinal and urinary samples, the pooled sensitivity was lower in pleural fluid (37%, 95%CI 26-50, meta-regression P < 0.001) and higher in lymph node samples (87%, 95%CI 75-95, meta-regression P = 0.03). CONCLUSION: Xpert has high specificity but limited sensitivity for the detection of EPTB. Although positive Xpert test results may be useful in rapidly identifying EPTB cases, negative test results provide less certainty for ruling out disease.
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An additional meta-analysis showed a pooled sensitivity of 87% and a specificity of 92% for Xpert MTB/RIF against TB culture for the diagnosis of TB lymphadenitis.
“An additional meta-analysis which also examined Xpert MTB/RIF against TB culture for the diagnosis of TB lymphadenitis showed a slightly better pooled sensitivity (87 %) and a similar specificity (92 %) [36].”
From Evaluation of Xpert® MTB/RIF and Ustar EasyNAT™ TB IAD for diagnosis of tuberculous lymphadenitis of children in Tanzania: a prospective descriptive study (2016) · cites this paper as [36]
The specificity of Xpert in the current study (91%) is consistent with previous studies (89-99%).
“The specificity (91%) of the Xpert in the current study was found to be consistent with previous studies reported by others (specificity, 89–99%) [20,21,22], but higher than the study done by Biadigilegn et al (specificity, 69.2%) [13].”
From GeneXpert MTB/RIF Assay for the Diagnosis of Tuberculous Lymphadenitis on Concentrated Fine Needle Aspirates in High Tuberculosis Burden Settings (2015) · cites this paper as [21]
Penz et al. reviewed 36 studies and confirmed Xpert pooled sensitivity of 87%.
“More recently, Penz et al reviewed 36 studies in their meta-analyses and confirmed Xpert pooled sensitivity of 87% that is similar to our study[21].”
From GeneXpert MTB/RIF Assay for the Diagnosis of Tuberculous Lymphadenitis on Concentrated Fine Needle Aspirates in High Tuberculosis Burden Settings (2015) · cites this paper as [21]
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“The specificity (91%) of the Xpert in the current study was found to be consistent with previous studies reported by others (specificity, 89–99%) [20,21,22], but higher than the study done by Biadigilegn et al (specificity, 69.”
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“Nevertheless, negative results cannot rule out the disease [40].”
BackgroundXpert® MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance
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“6 %) [24–27], leaving a significant proportion of TB disease reliant on suboptimal accuracy from diagnostic tests.”
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“paucibacillary nature of these specimens documented in other studies and meta-analysis [14, 16, 42].”
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“Many meta-analyses have been performed to evaluate the diagnostic accuracy of Xpert MTB/RIF for TPE (40-45).”
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“Systematic review and meta-analysis published in 2014 and 2015 showed good diagnostic efficiency of Xpert MTB/RIF for LNTB [3, 48].”
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“However, other studies have reported a higher sensitivity as compared to our findings [27, 28].”
ResultHow can gastro-intestinal tuberculosis diagnosis be improved? A prospective cohort study
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“An additional meta-analysis which also examined Xpert MTB/RIF against TB culture for the diagnosis of TB lymphadenitis showed a slightly better pooled sensitivity (87 %) and a similar specificity (92 %) [36].”
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“While urine Xpert MTB/RIF has shown utility in extrapulmonary TB (Atherton et al., 2019, Atherton et al., 2018, Penz et al., 2015), polymerase chain reaction (PCR) testing of urine for pulmonary TB has shown modest results.”
BackgroundRapid Molecular Diagnosis of Extra-Pulmonary Tuberculosis by Xpert/RIF Ultra
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“An example of GeneXpert was given which has very poor detection rate of TB in ascitic and pleural fluids.[4] Though liquid culture has reasonably acceptable detection rate, but it takes 2–3 weeks to grow the mycobacteria.”
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Xpert MTB/RIF assay for the diagnosis of rifampicin resistance in different regions: a meta-analysis
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“…MTB detection in bronchial alveolar lavage fluid (BALF) and non-respiratory samples, such as body fluid, fine needle aspiration, and different tissues, and it presents useful diagnostic value for extrapulmonary TB (Barnard et al., 2012; Penz et al., 2015; Sehgal et al., 2016; Rufai et al., 2017).”
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“[18], but still lower in comparison to other studies mentioned above [15-17,19,20].”
BackgroundResultDiagnostic accuracy of Xpert MTB/RIF assay for musculoskeletal tuberculosis: a meta-analysis
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“12 The WHO also recommended Xpert for the diagnosis of EPTB in 2013, 13 and this technology was indicated by another meta-analysis to have high specificity but relatively low sensitivity in the detection of EPTB.”
Evaluating diagnostic performance of Truenat MTB Plus for gastrointestinal tuberculosis
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“2014; Penz et al., 2015; Ligthelm et al., 2011), while it is almost same to a study (Sarfaraz et al., 2018).”
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“It means, a negative result does not exclude the disease [39].”
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- Authors
- Penz, E., Boffa, J., Roberts, D. J., Fisher, D., Cooper, R., Ronksley, P. E., & James, M. T.
- Affiliations
- University of Saskatchewan (CA)
- University of Calgary (CA)
- Foothills Medical Centre (CA)
- Royal Alexandra Hospital (CA)
- Ottawa Hospital (CA)
- Venue
- The International Journal of Tuberculosis and Lung Disease
- Published
- 2015-03-01
- Volume
- 19
- Issue
- 3
- Pages
- 278-284
- ISSN
- 1027-3719 (ISSN-L)
- OpenAlex
- W1998310606
- Cited by
- 97
- References
- 0
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 4 · 2023: 5 · 2022: 16 · 2021: 11 · 2020: 13 · 2019: 12 · 2018: 9 · 2017: 10 · 2016: 6 · 2015: 3
- FWCI
- 7.28
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The International Journal of Tuberculosis and Lung Disease (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
- Health Sciences › Medicine › Surgery › Diagnosis and treatment of tuberculosis
- Keywords
- Xpert MTB/RIF, extrapulmonary tuberculosis, diagnostic accuracy, nucleic acid amplification tests, sensitivity and specificity, pleural fluid, cerebrospinal fluid, gastrointestinal tuberculosis, urinary tuberculosis, cultural comparison
- MeSH terms
- Antibiotics, Antitubercular, Humans, Mycobacterium tuberculosis, Sensitivity and Specificity, Tuberculosis, Pulmonary, Nucleic Acid Amplification Techniques, Molecular Diagnostic Techniques
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