{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T10:30:11Z","timestamp":1788604211924,"version":"build-2803163510"},"reference-count":31,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"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>\n                    Tuberculosis (TB), caused by\n                    <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                    remains a global threat, affecting 10.8 million people and causes 1.3 million deaths annually. Over 2.5 million cases go undiagnosed partly due to current diagnostic limitations. In particular, smear microscopy is less sensitive, culture is slow and prone to contamination, and the rapid Xpert\u00ae MTB\/RIF Ultra (Ultra) needs advanced infrastructure. This study assessed the diagnostic accuracy of TrueNat\u2122 MTB Plus assay (TrueNat), a portable, WHO-endorsed point-of-care tool, compared to Ultra, smear microscopy, and L\u00f6wenstein\u2013Jensen (LJ) culture. This cross-sectional study enrolled 260 consenting adult participants (\u226518 years) with presumptive TB in northern Tanzania. Participants\u2019 sputum samples were tested for\n                    <jats:italic>M. tuberculosis<\/jats:italic>\n                    using smear microscopy, LJ culture, Ultra and TrueNat. TrueNat performance was assessed using sensitivity, specificity, predictive values and area under the curve (AUC) against the standard-of-care and a composite reference standard. Age and body-mass-index were summarised using median and interquatile range (IQR). Categorical variables were reported as proportions. Multivariate logistic regression identified TB predictors (p\u2009&lt;\u20090.05). Data analysis and visualization were conducted using R. Among 260 participants, 165 (63.5%) were male, with a median age of 46.0 years (IQR: 35.5\u201357.3); 15 (5.8%) were HIV-positive, and 52 (20%) had undernutrition. TB was detected in 109 (41.9%) participants by at least one test. TrueNat showed sensitivity\/specificity of 34.4%\/94.7% vs. smear microscopy, 98.9%\/95.3% vs. culture, and 86.2%\/95.2% vs. Ultra. The AUC values were 0.75, 0.92, 0.96, and 0.91 compared to smear microscopy, LJ culture, Ultra, and a composite reference method, respectively. Participants reporting weight loss were 2.84 times more likely (95% CI: 1.68\u20134.84, p\u2009&lt;\u20090.001) to test positive for TB by TrueNat. The TrueNat compared favorably to both Ultra and culture in terms of diagnostic accuracy, offering the added benefits of faster results and greater suitability for resource-limited settings. These findings suggest that TrueNat is a promising test for rapid TB detection in low-resource settings, warranting further studies to evaluate its implementation and impact on patient management.\n                  <\/jats:p>","DOI":"10.1371\/journal.pone.0327936","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T18:25:04Z","timestamp":1766427904000},"page":"e0327936","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["Diagnostic accuracy of the TrueNat\u2122 MTB plus assay for detecting pulmonary tuberculosis in adults"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9436-1098","authenticated-orcid":true,"given":"Sarapia P.","family":"Mallya","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2693-187X","authenticated-orcid":true,"given":"Peter M.","family":"Mbelele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riziki M.","family":"Kisonga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daphine D.","family":"Mtunga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haroun H.","family":"Banzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen S.","family":"Mpiima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muzafaru","family":"Twinomujuni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Bazira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kennedy","family":"Kassaza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,12,22]]},"reference":[{"key":"pone.0327936.ref001","unstructured":"WHO. Global tuberculosis report, 2023. 2023."},{"key":"pone.0327936.ref002","unstructured":"Report of the Tanzania Mid-Term Review of the National Tuberculosis and Leprosy Programme Strategic Plan VI, 1 Table of Contents. 2023."},{"key":"pone.0327936.ref003","first-page":"133","article-title":"Performance of the Truenat tuberculosis and rifampicin-resistance assays in the microscopy centre: a prospective multicentre diagnostic accuracy study","author":"m Penn-Nicholson A d a","year":"2022","journal-title":"Lancet Psych"},{"key":"pone.0327936.ref004","unstructured":"WHO. Consolidated guidelines on tuberculosis. 2021."},{"issue":"4","key":"pone.0327936.ref005","doi-asserted-by":"crossref","first-page":"912","DOI":"10.1128\/JCM.02505-15","article-title":"MTBDRplus and MTBDRsl Assays: Absence of Wild-Type Probe Hybridization and Implications for Detection of Drug-Resistant Tuberculosis","volume":"54","author":"M Seifert","year":"2016","journal-title":"J Clin Microbiol"},{"key":"pone.0327936.ref006","unstructured":"NTLP. Tuberculosis Cases Notified in 2022. Report. 2022;2022."},{"key":"pone.0327936.ref007","unstructured":"FIND, ICMR. World health organization endorses Truenat tests for initial diagnosis of tuberculosis and detection of rifampicin resistance. 2020."},{"issue":"8","key":"pone.0327936.ref008","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1080\/14787210.2024.2389876","article-title":"Evaluation of truenat assays for the diagnosis of pulmonary and extrapulmonary tuberculosis: a systematic review and meta-analysis","volume":"22","author":"S Mahmoudi","year":"2024","journal-title":"Expert Rev Anti Infect Ther"},{"key":"pone.0327936.ref009","doi-asserted-by":"crossref","unstructured":"Ssengooba W, Katamba A, Sserubiri J, Semugenze D, Nyombi A, Byaruhanga R, et al. Performance evaluation of Truenat MTB and Truenat MTB-RIF DX assays in comparison to gene XPERT MTB\/ RIF ultra for the diagnosis of pulmonary tuberculosis in Uganda. 2024:1\u20138.","DOI":"10.1186\/s12879-024-09063-z"},{"key":"pone.0327936.ref010","doi-asserted-by":"crossref","first-page":"100709","DOI":"10.1016\/j.ijmmb.2024.100709","article-title":"Diagnostic accuracy of truenat MTB plus for the detection of pulmonary and extrapulmonary tuberculosis","volume":"51","author":"RA Jose","year":"2024","journal-title":"Indian J Med Microbiol"},{"key":"pone.0327936.ref011","article-title":"Epidemiological Review in the United Republic of Tanzania","author":"M Report","year":"2023"},{"key":"pone.0327936.ref012","doi-asserted-by":"crossref","first-page":"193","DOI":"10.1016\/j.jbi.2014.02.013","article-title":"Sample size estimation in diagnostic test studies of biomedical informatics","volume":"48","author":"K Hajian-Tilaki","year":"2014","journal-title":"J Biomed Inform"},{"issue":"9","key":"pone.0327936.ref013","doi-asserted-by":"crossref","first-page":"1057","DOI":"10.1111\/tmi.13638","article-title":"TB or not TB? Definitive determination of species within the Mycobacterium tuberculosis complex in unprocessed sputum from adults with presumed multidrug-resistant tuberculosis","volume":"26","author":"PM Mbelele","year":"2021","journal-title":"Trop Med Int Health"},{"key":"pone.0327936.ref014","volume-title":"Mycobacteriology laboratory manual","author":"GLI","year":"2014"},{"issue":"12","key":"pone.0327936.ref015","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0261084","article-title":"Diagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia","volume":"16","author":"A Meaza","year":"2021","journal-title":"PLoS ONE"},{"key":"pone.0327936.ref016","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/s12879-017-2931-6","article-title":"Improved performance of Xpert MTB\/RIF assay on sputum sediment samples obtained from presumptive pulmonary tuberculosis cases at Kibong\u2019oto infectious diseases hospital in Tanzania","volume":"17","author":"PM Mbelele","year":"2017","journal-title":"BMC Infect Dis"},{"key":"pone.0327936.ref017","doi-asserted-by":"crossref","unstructured":"Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB\/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011;377:1495\u2013505. https:\/\/doi.org\/10.1016\/S0140-6736(11)60438-8","DOI":"10.1016\/S0140-6736(11)60438-8"},{"key":"pone.0327936.ref018","doi-asserted-by":"crossref","first-page":"86","DOI":"10.1016\/j.ijid.2024.01.003","article-title":"Diagnostic accuracy of Xpert MTB\/RIF Ultra for childhood tuberculosis in West Africa - a multicenter pragmatic study","volume":"140","author":"AB Diallo","year":"2024","journal-title":"Int J Infect Dis"},{"issue":"4","key":"pone.0327936.ref019","doi-asserted-by":"crossref","first-page":"199","DOI":"10.5588\/ijtldopen.24.0561","article-title":"Accuracy of Truenat\u2122 MTB Plus for the diagnosis of pulmonary TB","volume":"2","author":"MCM Melo","year":"2025","journal-title":"IJTLD Open"},{"issue":"1","key":"pone.0327936.ref020","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1186\/s12879-024-09063-z","article-title":"Performance evaluation of Truenat MTB and Truenat MTB-RIF DX assays in comparison to gene XPERT MTB\/RIF ultra for the diagnosis of pulmonary tuberculosis in Uganda","volume":"24","author":"W Ssengooba","year":"2024","journal-title":"BMC Infect Dis"},{"issue":"1","key":"pone.0327936.ref021","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1186\/s12913-020-4997-x","article-title":"Challenges with scale-up of GeneXpert MTB\/RIF\u00ae in Uganda: a health systems perspective","volume":"20","author":"T Nalugwa","year":"2020","journal-title":"BMC Health Serv Res"},{"issue":"8","key":"pone.0327936.ref022","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2021-005357","article-title":"Unlocking the health system barriers to maximise the uptake and utilisation of molecular diagnostics in low-income and middle-income country setting","volume":"6","author":"NE Ntinginya","year":"2021","journal-title":"BMJ Glob Health"},{"issue":"3","key":"pone.0327936.ref023","article-title":"Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents","volume":"3","author":"LR Inbaraj","year":"2025","journal-title":"Cochrane Database Syst Rev"},{"issue":"5","key":"pone.0327936.ref024","doi-asserted-by":"crossref","first-page":"2100526","DOI":"10.1183\/13993003.00526-2021","article-title":"A prospective multicentre diagnostic accuracy study for the Truenat tuberculosis assays","volume":"58","author":"A Penn-Nicholson","year":"2021","journal-title":"Eur Respir J"},{"issue":"1","key":"pone.0327936.ref025","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0051121","article-title":"Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: a near-care approach","volume":"8","author":"C Nikam","year":"2013","journal-title":"PLoS One"},{"issue":"9","key":"pone.0327936.ref026","doi-asserted-by":"crossref","first-page":"1356","DOI":"10.1093\/infdis\/jiy675","article-title":"Undernutrition and Tuberculosis: Public Health Implications","volume":"219","author":"P Sinha","year":"2019","journal-title":"J Infect Dis"},{"issue":"10","key":"pone.0327936.ref027","doi-asserted-by":"crossref","DOI":"10.1016\/S1473-3099(20)30792-1","article-title":"Food for thought: addressing undernutrition to end tuberculosis","volume":"21","author":"P Sinha","year":"2021","journal-title":"Lancet Infect Dis"},{"issue":"2","key":"pone.0327936.ref028","doi-asserted-by":"crossref","first-page":"170","DOI":"10.5588\/ijtld.19.0002","article-title":"The impact of smoking on tuberculosis treatment outcomes: a meta-analysis","volume":"24","author":"EY Wang","year":"2020","journal-title":"Int J Tuberc Lung Dis"},{"issue":"2","key":"pone.0327936.ref029","doi-asserted-by":"crossref","first-page":"151","DOI":"10.3390\/pathogens13020151","article-title":"Cigarette Smoking as a Risk Factor for Tuberculosis in Adults: Epidemiology and Aspects of Disease Pathogenesis","volume":"13","author":"C Feldman","year":"2024","journal-title":"Pathogens"},{"key":"pone.0327936.ref030","doi-asserted-by":"crossref","unstructured":"Ranjan P, Rukadikar AR, Hada V, Mohanty A, Singh P. Diagnostic evaluation of Tru-Nat MTB\/Rif test in comparison with microscopy for diagnosis of pulmonary tuberculosis at tertiary care hospital of eastern Uttar Pradesh. 2024.","DOI":"10.18502\/ijm.v16i4.16305"},{"issue":"4","key":"pone.0327936.ref031","doi-asserted-by":"crossref","first-page":"181","DOI":"10.5588\/pha.18.0056","article-title":"Sputum smear-positive, Xpert\u00ae MTB\/RIF-negative results: magnitude and treatment outcomes of patients in Myanmar","volume":"8","author":"MH Phyu","year":"2018","journal-title":"Public Health Action"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0327936","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T18:25:09Z","timestamp":1766427909000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0327936"}},"subtitle":[],"editor":[{"given":"Felix","family":"Bongomin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,12,22]]},"references-count":31,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,12,22]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0327936","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,22]]}}}