{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T12:16:18Z","timestamp":1788264978612,"version":"build-2803163510"},"reference-count":18,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2021,6,14]],"date-time":"2021-06-14T00:00:00Z","timestamp":1623628800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>India has been engaged in tuberculosis (TB) control activities for over 50 years and yet TB continues to remain India\u2019s important public health problem. The present study was conducted to compare the performance of GeneXpert MTB\/RIF (GXpert) assay with composite reference standard in diagnosing cases of tubercular pleural effusion (TPE) and to evaluate the reliability of rifampicin resistance. A cross-sectional study was performed in a Department of Medicine of a rural teaching tertiary care hospital in central India. In all consecutive patients with pleural effusion on chest radiograph presenting to Department of Medicine, GXpert assay and composite reference standard was performed to evaluate the diagnostic accuracy of GXpert assay for detecting TPE in comparison to composite reference standard. Standard formulae were used to calculate the sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV), positive likelihood ratios (LR+) and negative likelihood ratios (LR-). Mc-Nemar\u2019s test was applied to compare variables. All comparisons were two-tailed. We considered the difference to be statistically significant if the P value was less than 0.05. The sensitivity of the GXpert assay in diagnosing TPE was 16.6% among 158 study participants, the specificity was 100% and diagnostic accuracy was 52.5% which was statistically significant (p value &lt; 0.05). It had a PPV of 100% (95%CI: 88.3% - 100%) and a NPV of 47.5% (95%CI: 39.3% - 55.7%). The LR+ and LR-were 23.5 (95%CI: 1.43\u201338.6) and 0.83 (95%CI: 0.76\u20130.91) respectively. GXpert assay has a very high specificity in diagnosing TPE but has a low sensitivity. In comparison to composite reference standard Thus its clinical utility is limited when used as a standalone test. A physician\u2019s clinical acumen in combination with routine pleural fluid analysis should be the key factor in the diagnosis of TPE in clinically and radiologically suspected patients, especially in high TB burden countries.<\/jats:p>","DOI":"10.1371\/journal.pone.0251618","type":"journal-article","created":{"date-parts":[[2021,6,14]],"date-time":"2021-06-14T17:22:01Z","timestamp":1623691321000},"page":"e0251618","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":14,"title":["Diagnostic accuracy of GeneXpert MTB\/RIF assay for detection of tubercular pleural effusion"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7631-0791","authenticated-orcid":true,"given":"Jyoti","family":"Jain","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0012-6629","authenticated-orcid":true,"given":"Pooja","family":"Jadhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6541-4234","authenticated-orcid":true,"given":"Shashank","family":"Banait","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Preetam","family":"Salunkhe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2021,6,14]]},"reference":[{"key":"pone.0251618.ref001","unstructured":"Programme WHOGT (2013) Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB\/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children."},{"key":"pone.0251618.ref002","first-page":"316","article-title":"Extrapulmonary tuberculosis","volume":"120","author":"SK S","year":"2004","journal-title":"Indian J Med Res"},{"key":"pone.0251618.ref003","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1128\/JCM.01463-09","article-title":"Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of","volume":"48","author":"D H","year":"2010","journal-title":"J Clin Microbiol"},{"key":"pone.0251618.ref004","doi-asserted-by":"crossref","first-page":"2540","DOI":"10.1128\/JCM.02319-10","article-title":"Xpert MTB\/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis?","volume":"49","author":"V V","year":"2011","journal-title":"J Clin Microbiol"},{"key":"pone.0251618.ref005","doi-asserted-by":"crossref","first-page":"877","DOI":"10.1080\/00365510701459742","article-title":"Pleural fluid ADA, IgA-ELISA and PCR sensitivities for the diagnosis of pleural","volume":"67","author":"A T","year":"2007","journal-title":"Scand J Clin Lab Invest"},{"key":"pone.0251618.ref006","unstructured":"(2016) Technical and Operational Guidelines for TB Control in India, Revised National Tuberculosis Control Programme.Central tuberculosis division."},{"key":"pone.0251618.ref007","unstructured":"Programme WHOGT (2014) Xpert MTB\/RIF implementation manual: technical and operational \u2019how-to\u2019: practical considerations."},{"key":"pone.0251618.ref008","doi-asserted-by":"crossref","first-page":"1067","DOI":"10.2217\/fmb.11.84","article-title":"Xpert(R) MTB\/RIF assay: development, evaluation and implementation of a new rapid","volume":"6","author":"SD L","year":"2011","journal-title":"Future Microbiol"},{"key":"pone.0251618.ref009","doi-asserted-by":"crossref","first-page":"910","DOI":"10.1099\/jmm.0.000522","article-title":"Rapid diagnosis of extrapulmonary tuberculosis with Xpert Mycobacterium","volume":"66","author":"Y L","year":"2017","journal-title":"J Med Microbiol"},{"key":"pone.0251618.ref010","doi-asserted-by":"crossref","first-page":"1133","DOI":"10.1128\/JCM.03205-15","article-title":"Diagnostic Performance of Xpert MTB\/RIF in Tuberculous Pleural Effusion","volume":"54","author":"IS S","year":"2016","journal-title":"J Clin Microbiol"},{"key":"pone.0251618.ref011","doi-asserted-by":"crossref","first-page":"917","DOI":"10.5588\/ijtld.12.0885","article-title":"Diagnostic accuracy of Xpert\u00ae MTB\/RIF on bronchoscopy specimens in patients with suspected pulmonary tuberculosis","volume":"17","author":"HY Lee","year":"2013","journal-title":"Int J Tuberc Lung Dis"},{"key":"pone.0251618.ref012","doi-asserted-by":"crossref","first-page":"3636","DOI":"10.1128\/JCM.02182-15","article-title":"Performance of Xpert MTB\/RIF Assay in Diagnosis of Pleural Tuberculosis by Use of","volume":"53","author":"SB R","year":"2015","journal-title":"J Clin Microbiol"},{"key":"pone.0251618.ref013","doi-asserted-by":"crossref","first-page":"4341","DOI":"10.1128\/JCM.05454-11","article-title":"Xpert MTB\/RIF assay for diagnosis of pleural tuberculosis","volume":"49","author":"SO F","year":"2011","journal-title":"J Clin Microbiol"},{"key":"pone.0251618.ref014","first-page":"26","article-title":"Rapid diagnosis of pleural tuberculosis by Xpert MTB\/RIF assay using pleural","volume":"20","author":"J D","year":"2015","journal-title":"J Res Med Sci"},{"key":"pone.0251618.ref015","doi-asserted-by":"crossref","first-page":"0102702","DOI":"10.1371\/journal.pone.0102702","article-title":"Evaluation of Cepheid\u2019s Xpert MTB\/Rif test on pleural fluid in the diagnosis of","volume":"9","author":"JK L","year":"2014","journal-title":"PLoS One"},{"key":"pone.0251618.ref016","first-page":"1471","article-title":"Comparison of same day diagnostic tools including Gene Xpert and unstimulated","volume":"14","author":"R M","year":"2014","journal-title":"BMC Pulm Med"},{"key":"pone.0251618.ref017","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.5588\/ijtld.13.0178","article-title":"Xpert(R) MTB\/RIF in pleural fluid for the diagnosis of tuberculosis","volume":"17","author":"JM P","year":"2013","journal-title":"Int J Tuberc Lung Dis"},{"key":"pone.0251618.ref018","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1183\/09031936.00007814","article-title":"Xpert MTB\/RIF assay for the diagnosis of extrapulmonary tuberculosis: a","volume":"44","author":"D CM","year":"2014","journal-title":"Eur Respir J"}],"container-title":["PLOS 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