Diagnostic accuracy of the Xpert MTB/RIF assay for tuberculous pericarditis: A protocol of systematic review and meta-analysis.
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ABSTRACT: Background
Tuberculous pericarditis (TBP) can lead to serious consequences. Early diagnosis and treatment are very important for TBP, but early diagnosis is still very challenging. This study aims to evaluate the diagnostic accuracy of Xpert MTB/RIF for TBP using meta-analysis method.Methods
We will search Embase, PubMed, the Cochrane Library, China National Knowledge Infrastructure (CNKI), and the Wanfang database for researches assessing the diagnostic accuracy of Xpert MTB/RIF for TBP until April 2021. Any types of study design with full text will be selected and included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool will be used to assess the risk of bias. We will use version 15.0 of the STATA software with the midas command packages to carry out meta-analyses.Results
Evidence for diagnostic accuracy of Xpert MTB/RIF for TBP will be provided through the study, and this protocol will be submitted to a peer-reviewed journal for publication.Conclusion
This study will provide evidence of Xpert MTB/RIF for TBP.
SUBMITTER: Yu G
PROVIDER: S-EPMC8153464 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThe purpose of this study was to evaluate the diagnostic efficacy of Xpert MTB/RIF for tuberculous pericarditis (TBP).MethodsWe searched relevant databases for Xpert MTB/RIF for TBP diagnosis until April 2021 and screened eligible studies for study inclusion. We evaluated the effectiveness of Xpert MTB/RIF when the composite reference standard (CRS) and mycobacterial culture were the gold standards, respectively. We performed meta-analyses using a bivariate random-effects model, and when the heterogeneity was obvious, the source of heterogeneity was further discussed.ResultsWe included seven independent studies comparing Xpert MTB/RIF with the CRS and six studies comparing it with culture. The pooled sensitivity, specificity, and area under the curve of Xpert MTB/RIF were 65% (95% confidence interval, 59-72%), 99% (97-100%), and 0.99 (0.97-0.99) as compared with the CRS, respectively, and 75% (53-88%), 99% (90-100%), and 0.94 (0.92-0.96) as compared with culture, respectively. There was no significant heterogeneity between studies when CRS was the gold standard, whereas heterogeneity was evident when culture was the gold standard.ConclusionsThe sensitivity of Xpert MTB/RIF for diagnosing TBP was moderate and the specificity was good; thus, Xpert MTB/RIF can be used in the initial diagnosis of TBP.
| S-EPMC8432788 | biostudies-literature
Project description:Introduction: Xpert MTB/RIF is a rapid diagnostic instrument for pulmonary tuberculosis (TB). However, studies reported varied accuracy of Xpert MTB/RIF in detecting Mycobacterium tuberculosis in pericardial effusion. Methods: We performed a systematic review of literature in PubMed, published up to February 1, 2020, according to PRISMA guidelines. We screened cross-sectional studies, observational cohort studies, and randomized control trials that evaluated the accuracy of Xpert MTB/RIF in diagnosing TB pericarditis. Papers with noninterpretable results of sensitivity and specificity, non-English articles, and unpublished studies were excluded. The primary outcomes were the sensitivity and specificity of Xpert MTB/RIF. We conducted a quality assessment using QUADAS-2 to evaluate the quality of the studies. A bivariate model pooled the overall sensitivity, specificity, positive likelihood ratios (PLRs), and negative likelihood ratios (NLRs) of included studies. Results: In total, 581 subjects from nine studies were analyzed in this meta-analysis. Our pooled analysis showed that the overall sensitivity, specificity, PLRs and NLRs of included studies were 0.676 (95% CI: 0.580-0.759), 0.994 (95% CI: 0.919-1.000), 110.11 (95% CI: 7.65-1584.57) and 0.326 (95% CI: 0.246-0.433), respectively. Conclusions: Xpert MTB/RIF had a robust specificity but unsatisfactory sensitivity in diagnosing TB pericarditis. These findings indicated that although positive Xpert MTB/RIF test results might be valuable in swiftly distinguishing the diagnosis of TB pericarditis, negative test results might not be able to rule out TB pericarditis. Registration: PROSPERO CRD42020167480 28/04/2020.
| S-EPMC7417956 | biostudies-literature
Project description:ObjectiveThis systematic review evaluated the diagnostic accuracy of Xpert MTB/RIF to detect tuberculous meningitis (TBM).MethodsPubMed and five other databases were systematically searched through March 2019. All studies evaluating diagnostic accuracy of Xpert MTB/RIF on cerebrospinal fluid (CSF) samples were included. Reference standards were definitive or definite plus probable TBM. The quality of studies was assessed by the QUADAS-2 tool. We performed bivariate random-effects meta-analysis and calculated summary diagnostic statistics.ResultsWe identified 30 studies (n = 3972 participants), including 5 cohort studies and 25 cross-sectional studies. Reference standards were definite TB (n = 28 studies) or definite plus probable TBM (n = 6 studies). The pooled Xpert MTB/RIF sensitivity was 85% (95% CI, 70-93%), and specificity was 98% (95% CI, 97-99%) with a negative likelihood ratio of 0.15 (95% CI, 0.04-0.27) for definite TBM. For probable TBM cases, pooled sensitivity was 81% (95% CI, 66-90%), and specificity was 99% (95% CI, 97-99%). For both reference standard types, meta-analyses showed a C-statistic area under the curve of 0.98. The QUADAS-2 tool revealed low risk of bias as well as low concerns regarding applicability. Methodological heterogeneity was high among studies.ConclusionsXpert MTB/RIF showed high accuracy for TBM diagnosis, but a negative Xpert MTB/RIF test does not rule out TBM. Repeat Xpert testing may be necessary. In clinical practice, Xpert MTB/RIF adds speed and sensitivity when compared to classic TBM diagnostic methods or previous commercial nucleic acid amplification techniques. More studies and better strategies for rapidly confirming a diagnosis of TBM in children are urgently needed.
| S-EPMC7902353 | biostudies-literature
Project description:BackgroundXpert MTB/RIF Ultra (Xpert Ultra) might have higher sensitivity than its predecessor, Xpert MTB/RIF (Xpert), but its role in tuberculous meningitis diagnosis is uncertain. We aimed to compare Xpert Ultra with Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults.MethodsIn this prospective, randomised, diagnostic accuracy study, adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam were randomly assigned to cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline and, if treated for tuberculous meningitis, after 3-4 weeks of treatment. Test performance (sensitivity, specificity, and positive and negative predictive values) was calculated for Xpert Ultra and Xpert and compared against clinical and mycobacterial culture reference standards. Analyses were done for all patients and by HIV status.FindingsBetween Oct 16, 2017, and Feb 10, 2019, 205 patients were randomly assigned to Xpert Ultra (n=103) or Xpert (n=102). The sensitivities of Xpert Ultra and Xpert for tuberculous meningitis diagnosis against a reference standard of definite, probable, and possible tuberculous meningitis were 47·2% (95% CI 34·4-60·3; 25 of 53 patients) for Xpert Ultra and 39·6% (27·6-53·1; 21 of 53) for Xpert (p=0·56); specificities were 100·0% (95% CI 92·0-100·0; 44 of 44) and 100·0% (92·6-100·0; 48 of 48), respectively. In HIV-negative patients, the sensitivity of Xpert Ultra was 38·9% (24·8-55·1; 14 of 36) versus 22·9% (12·1-39·0; eight of 35) by Xpert (p=0·23). In HIV co-infected patients, the sensitivities were 64·3% (38·8-83·7; nine of 14) for Xpert Ultra and 76·9% (49·7-91·8; ten of 13) for Xpert (p=0·77). Negative predictive values were 61·1% (49·6-71·5) for Xpert Ultra and 60·0% (49·0-70·0) for Xpert. Against a reference standard of mycobacterial culture, sensitivities were 90·9% (72·2-97·5; 20 of 22 patients) for Xpert Ultra and 81·8% (61·5-92·7; 18 of 22) for Xpert (p=0·66); specificities were 93·9% (85·4-97·6; 62 of 66) and 96·9% (89·5-91·2; 63 of 65), respectively. Six (22%) of 27 patients had a positive test by Xpert Ultra after 4 weeks of treatment versus two (9%) of 22 patients by Xpert.InterpretationXpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. A negative Xpert Ultra or Xpert test does not rule out tuberculous meningitis. New diagnostic strategies are urgently required.FundingWellcome Trust and the Foundation for Innovative New Diagnostics.
| S-EPMC7045088 | biostudies-literature
Project description:BackgroundTuberculosis poses a severe threat to human health. At present, compared with the traditional diagnostic methods for tuberculosis pleural effusion, such as Löwenstein-Jensen culture, pleural biopsy, and Ziehl-Neelsen smear microscopy, Xpert MTB/RIF was regarded as an emerging technology for its efficiency. The Xpert MTB/RIF accuracy for tuberculous pleural effusion diagnosis was evaluated in this systematic study.Materials and methodsWe searched the relevant literature published before January 2021 in PubMed, Cochrane, EMBASE, and Web of Science databases. Utilizing Review Manager 5.3 software, the quality of the included literature was evaluated based on the Quality Assessment of Diagnostic Accuracy Studies criteria. Sensitivity, specificity, and the summary receiver operating characteristic curves were plotted and analyzed with Metadisc 1.40 software. We used Stata 12.0 software to evaluate the publication bias of this study.ResultsEighteen articles were identified in total. The sensitivity of Xpert MTB/RIF in the pleural effusion was 0.24, and specificity was 1.00, respectively. The area under the summary receiver operating characteristic curve was 0.9737, which indicated that the overall accuracy of the Xpert MTB/RIF was high. In addition, based on the Deeks funnel plot, no publication bias of the study was found.ConclusionXpert MTB/RIF is a rapid method with high specificity but relatively low sensitivity for detecting Mycobacterium tuberculosis in pleural effusion. Its less sensitivity made it difficult to be used clinically, but the high specificity suggests that it can be used as a specific diagnostic method for tuberculous pleural effusion.
| S-EPMC8761404 | biostudies-literature
Project description:BACKGROUND:This study aimed to evaluate the accuracy of the Xpert MTB/RIF assay for the diagnosis of bone and joint tuberculosis. METHODS:We searched databases from their inception to May 7, 2019 for published articles and reviewed them to assess the accuracy of Xpert MTB/RIF with respect to a composite reference standard (CRS) and mycobacterial culture. Meta-analyses were performed using a bivariate random-effects model, and the sources of heterogeneity were assessed via subgroup analysis and meta-regression. RESULTS:Nineteen independent (9 prospective, 5 retrospective, and 5 case-control) studies that compared Xpert MTB/RIF with the CRS and 14 (6 prospective, 7 retrospective, and 1 case-control) studies that compared it with culture were included. The pooled sensitivity and specificity of Xpert MTB/RIF were 81% (95% confidence interval [CI], 77-84) and 99% (95% CI, 97-100) compared to the CRS, respectively, and 96% (95% CI, 90-98) and 85% (95% CI, 57-96) compared to culture, respectively. The pooled sensitivity and specificity using pus samples vs. the CRS were 82% (95% CI, 76-86) and 99% (95% CI, 95-100), respectively. The proportions obtained while working with tissue samples vs. the CRS were 84% (95% CI, 76-90) and 98% (95% CI, 94-99), respectively. There was no significant difference in diagnostic accuracy among the types of specimens. CONCLUSIONS:Xpert MTB/RIF demonstrates good diagnostic accuracy for bone and joint tuberculosis, the results of which are not related to the type of specimen.
| S-EPMC6705841 | biostudies-literature
Project description:BACKGROUND:This study aimed to assess the diagnostic performance of Xpert MTB/RIF for tuberculous pericarditis (TBP) using pericardial tissues. METHODS:The study involved 30 patients admitted with suspected TBP from January-December 2016; three patients were later excluded. The interferon-? release assay (T-SPOT.TB) and the Xpert MTB/RIF test were performed using peripheral blood and pericardial tissues, respectively. TBP was confirmed using pericardial histopathology and a composite reference standard (CRS). We analyzed the sensitivity, specificity, predictive value (PV), likelihood ratio (LR), and area under curve (AUC) of both assays. RESULTS:Fourteen patients were confirmed as TBP, 10 as non-TBP, and 3 as probable TBP. The sensitivity, specificity, positive PV (PPV), negative PV (NPV), PLR, NLR, and AUC (95% confidence interval [CI]) of the Xpert MTB/RIF assay were 78.6% (49.2-95.3%) and 70.6% (44.0-89.7%); 92.3% (64.0-99.8%) and 100% (69.2-100%); 91.7% (61.5-99.8%) and 100% (73.5-100%); 80.0% (51.9-95.7%) and 66.7% (38.4-88.2%); 10.21 (1.52-68.49) and the PLR value was undefined with CRS as the reference; 0.23 (0.08-0.64) and 0.29(0.14-0.61); and 0.854 (0.666-0.959) and 0.853 (0.664-0.959), against histopathology and CRS, respectively. The sensitivity, specificity, PPV, NPV, PLR, NLR, and AUC values (95% CI) of T-SPOT.TB were 92.9% (66.1-99.8%) and 94.1% (71.3-99.9%); 15.4% (1.9-45.5%) and 20.0% (2.5-55.6%); 54.2% (32.8-74.5%) and 66.7% (44.7-84.4%); 66.7% (9.4-99.2%) and 66.7% (9.4-99.2%); 1.10 (0.83-1.44) and 1.18 (0.84-1.6); 0.46 (0.05-4.53) and 0.29 (0.03-2.85); and 0.541(0.340-0.733) and 0.571(0.367-0.758), against histopathology and CRS, respectively. The differences in sensitivity, PPV, and AUC of Xpert MTB/RIF and T-SPOT.TB were not statistically significant (P > 0.05), compared to those of histopathology and CRS. However, the differences in specificity and NPV of the two assays were significant (P < 0.05), compared to those of histopathology and CRS. CONCLUSIONS:Xpert MTB/RIF test is a valid diagnostic technique for TBP with higher sensitivity and specificity than T-SPOT.TB.
| S-EPMC5718425 | biostudies-literature
Project description:A systematic review investigating the role of Xpert MTB/RIF in the diagnosis of tuberculous pleural effusion (TPE) was conducted. The pooled sensitivities and specificities of Xpert MTB/RIF were 51.4% and 98.6%, respectively, with culture used as a reference standard and 22.7% and 99.8%, respectively, with a composite reference standard (CRS) used as the benchmark. Xpert MTB/RIF has low sensitivity but excellent specificity in the diagnosis of TPE.
| S-EPMC4809962 | biostudies-literature
Project description:ObjectivesTo evaluate the performance of Xpert MTB/RIF for lymph node tuberculosis (LNTB).MethodsWe searched databases for published reports. We reviewed the studies and identified the performance of Xpert MTB/RIF with respect to a composite reference standard (CRS) and culture. We used a bivariate random-effects model to perform meta-analyses and used metaregression to analyze sources of heterogeneity.Results15 independent studies compared Xpert MTB/RIF with CRS while 21 comparing it with culture were included. The pooled sensitivity and specificity of Xpert MTB/RIF were 79% and 98% compared to that of CRS, respectively, and 84% and 91% compared to that of culture, respectively. The pooled sensitivity and specificity using fine needle aspiration (FNA) samples versus CRS were 80% and 96%, whereas those against culture were 90% and 89%, respectively. The percentages while working with tissue samples versus CRS were 76% and 100%, respectively, whereas those against culture were 76% and 92%, respectively. There was no significant difference in diagnostic efficiency among the types of specimen.ConclusionsXpert MTB/RIF demonstrates good diagnostic efficiency for LNTB and is not related to the type of specimen, obtained via different routes.
| S-EPMC6545759 | biostudies-literature
Project description:ObjectiveWe compared diagnostic accuracy of pleural fluid Xpert MTB/RIF (Xpert) and Xpert MTB/RIF Ultra (Ultra) assays for diagnosing tuberculous pleural effusion (TPE), through systematic review and comparative meta-analysis.MethodsWe searched PubMed and Embase databases for publications reporting diagnostic accuracy of Xpert or Ultra for TPE. We used bivariate random-effects modeling to summarize diagnostic accuracy information from individual studies using either mycobacterial culture or composite criteria as reference standard. We performed meta-regression through hierarchical summary receiver operating characteristic (HSROC) modeling to evaluate comparative performance of the two tests from studies reporting diagnostic accuracy of both in the same study population.ResultsWe retrieved 1097 publications, and included 74 for review. Summary estimates for sensitivity and specificity for Xpert were 0.52 (95% CI 0.43-0.60, I2 82.1%) and 0.99 (95% CI 0.97-0.99, I2 85.1%), respectively, using culture-based reference standard; and 0.21 (95% CI 0.17-0.26, I2 81.5%) and 1.00 (95% CI 0.99-1.00, I2 37.6%), respectively, using composite reference standard. Summary estimates for sensitivity and specificity for Ultra were 0.68 (95% CI 0.55-0.79, I2 80.0%) and 0.97 (95% CI 0.97-0.99, I2 92.1%), respectively, using culture-based reference standard; and 0.47 (95% CI 0.40-0.55, I2 64.1%) and 0.98 (95% CI 0.95-0.99, I2 54.8%), respectively, using composite reference standard. HSROC meta-regression yielded relative diagnostic odds ratio of 1.28 (95% CI 0.65-2.50) and 1.80 (95% CI 0.41-7.84) respectively in favor of Ultra, using culture and composite criteria as reference standard.ConclusionUltra provides superior diagnostic accuracy over Xpert for diagnosing TPE, mainly because of its higher sensitivity.
| S-EPMC9273090 | biostudies-literature