{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T09:18:08Z","timestamp":1790673488562,"version":"4.1.0"},"reference-count":40,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T00:00:00Z","timestamp":1643846400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005068","name":"Jimma University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005068","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Ethiopia is one of the high burden countries for extrapulmonary tuberculosis (EPTB); however, the prompt diagnosis of EPTB remains challenging. This study is aimed to evaluate the diagnostic performance of Xpert MTB\/RIF and Determine<jats:sup>TM<\/jats:sup> TB-LAM Ag (TB-LAM) for the prompt diagnosis of EPTB in Ethiopia.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>A total of 147 presumptive EPTB patients, including 23 HIV- positive participants were enrolled. Extra-pulmonary samples were collected from all presumptive EPTB cases and tested for <jats:italic>Mycobacterium tuberculosis<\/jats:italic> complex (MTBC) using fluorescent microscopy, Xpert MTB\/RIF, and culture. Additionally, urine samples were also collected from 126 participants and were tested by Determine<jats:sup>TM<\/jats:sup> TB-LAM Ag (Alere Inc, Waltham, USA). The Sensitivity and specificity of Xpert and TB- LAM tests were calculated by comparing with a composite reference standard (CRS), which comprises smear microscopy, culture and response to empirical anti-TB treatment.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Of 147 patients, 23 (15.6%) were confirmed EPTB cases (culture-positive), 14 (9.5%) were probable EPTB (clinically, radiologically or cytologically positive and received anti-TB treatment with good response), and 110 (74.8%) were classified as \u201cnon- TB\u201d cases. Compared to the composite reference standard (CRS), the overall sensitivity and specificity of Xpert MTB\/RIF were 43.2% and 100%, respectively with the highest sensitivity for Lymph node aspirate (85.7%) and lower sensitivity for pleural fluid (14.3%) and 100% specificity for all specimen types. The sensitivity and specificity of TB-LAM were 33.3% and 94.4% respectively with the highest sensitivity for HIV co-infected participants (83.3%). The sensitivity of the combination of Xpert MTB\/RIF and TB-LAM tests regardless of HIV status was 61.1% whereas the sensitivity was improved to 83.3% for HIV-positive cases.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>TB-LAM alone has low sensitivity for EPTB diagnosis; however, the combination of TB-LAM and Xpert MTB\/RIF improves the diagnosis of EPTB particularly for countries with high EPTB and HIV cases.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0263172","type":"journal-article","created":{"date-parts":[[2022,2,3]],"date-time":"2022-02-03T18:46:03Z","timestamp":1643913963000},"page":"e0263172","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":21,"title":["Combination of Xpert\u00ae MTB\/RIF and DetermineTM TB-LAM Ag improves the diagnosis of extrapulmonary tuberculosis at Jimma University Medical Center, Oromia, Ethiopia"],"prefix":"10.1371","volume":"17","author":[{"given":"Asnake","family":"Simieneh","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4751-2225","authenticated-orcid":true,"given":"Mulualem","family":"Tadesse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wakjira","family":"Kebede","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mulatu","family":"Gashaw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7172-9136","authenticated-orcid":true,"given":"Gemeda","family":"Abebe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2022,2,3]]},"reference":[{"key":"pone.0263172.ref001","volume-title":"Global Tuberculosis 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KR. Xpert MTB\/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis","volume":"44","author":"Claudia M. Denkinger","year":"2014","journal-title":"Eur Respir J"},{"issue":"6","key":"pone.0263172.ref026","doi-asserted-by":"crossref","first-page":"1818","DOI":"10.1128\/JCM.03553-13","article-title":"Diagnostic accuracy of Xpert MTB\/RIF for extrapulmonary tuberculosis specimens: establishing a laboratory testing algorithm for South Africa","volume":"52","author":"LE Scott","year":"2014","journal-title":"J Clin Microbiol"},{"issue":"8","key":"pone.0263172.ref027","doi-asserted-by":"crossref","first-page":"e0201934","DOI":"10.1371\/journal.pone.0201934","article-title":"Improvement of Mycobacterium tuberculosis detection by Xpert MTB\/RIF Ultra: A head-to-head comparison on Xpert-negative samples","volume":"13","author":"F Bisognin","year":"2018","journal-title":"PLoS One"},{"issue":"4","key":"pone.0263172.ref028","article-title":"The New Xpert MTB\/RIF Ultra:improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing.","volume":"8","author":"S Chakravortya","year":"2017","journal-title":"MBio"},{"key":"pone.0263172.ref029","article-title":"A New Tool to Diagnose Tuberculosis:The Xpert MTB\/RIF Assay","author":"Center for Disease Control and Prevention. 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