{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T12:59:34Z","timestamp":1785416374148,"version":"3.56.0"},"posted":{"date-parts":[[2026,7,6]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":19,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T00:00:00Z","timestamp":1783296000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"award":["OPP1171455"],"award-info":[{"award-number":["OPP1171455"]}],"id":[{"id":"https:\/\/ror.org\/0456r8d26","id-type":"ROR","asserted-by":"publisher"}]},{"name":"Penn Center for AIDS Research","award":["P30 AI045008"],"award-info":[{"award-number":["P30 AI045008"]}]},{"name":"National Institute of Health","award":["K01 HL165095"],"award-info":[{"award-number":["K01 HL165095"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,7,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:p>\n                  Tongue swabs (TSs) are a non-invasive specimen type for the detection of\n                  <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                  complex (MTBC) and can expand access to testing for individuals unable to produce sputum. This study evaluated the diagnostic performance and user acceptability of self-collected and health worker (HW)-collected tongue swabs using the Xpert MTB\/RIF Ultra (Ultra) assay and assessed participant perspectives on self-collection.\n                <\/jats:p>\n                <jats:p>In this prospective, cross-sectional study, symptomatic and asymptomatic adults under investigation for TB were enrolled from a high HIV prevalence setting. Each participant provided both a self-collected and a HW-collected TS, which were tested using Ultra. Ultra TS results were compared to liquid culture as the reference standard and sputum Ultra as a comparator. Participant perspectives on self-collection were captured via questionnaires.<\/jats:p>\n                <jats:p>\n                  Sensitivity on Ultra for both self- and HW-collected TSs was 68% (95% CI:51.9-81.9), compared to liquid culture. This sensitivity was significantly higher than that of sputum smear microscopy (46%, 95% CI: 30.7\u201362.6; McNemar\u2019s\n                  <jats:italic>p = 0.003<\/jats:italic>\n                  ). Tongue swab sensitivity was lower than sputum Ultra (80.5%; p&lt;0.001) and decreased with low bacillary loads. Importantly, TSs enabled MTBC detection in six participants unable to produce sputum. Most participants (&gt;90%) found self-collection instructions easy to follow, reporting high confidence and comfort, and trust in results from self-collected TSs.\n                <\/jats:p>\n                <jats:p>This study demonstrates that self-collected TSs perform comparably to those collected by health workers for TB detection using Ultra and are both feasible and acceptable in a high TB\/HIV burden setting. To maximize impact, clear training instructions and robust linkage to care remain critical priorities.<\/jats:p>\n                <jats:sec>\n                  <jats:title>Importance<\/jats:title>\n                  <jats:p>\n                    This study supports the use of tongue swabs (TSs) as a non-invasive alternative for tuberculosis diagnosis, particularly for individuals unable to produce sputum. When tested on the Xpert MTB\/RIF Ultra assay, self-collected TSs performed comparably to health worker-collected swabs, yielding a 68% sensitivity (95% CI: 51.9\u201381.9) relative to liquid culture. This sensitivity was significantly higher than that of sputum smear microscopy (46%, 95% CI: 30.7\u201362.6; McNemar\u2019s\n                    <jats:italic>p = 0.003<\/jats:italic>\n                    ). Importantly, TSs successfully detected\n                    <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                    complex in six patients who could not provide sputum, underscoring their clinical utility in expanding diagnostic access. Furthermore, high user acceptability (&gt;90%) confirms that self-collection is both feasible and trusted by patients in high TB\/HIV burden settings. To maximize real-world impact, implementing clear training instructions and establishing robust linkage to care, especially following negative results, remain critical programmatic priorities.\n                  <\/jats:p>\n                <\/jats:sec>","DOI":"10.64898\/2026.07.04.26357275","type":"posted-content","created":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T23:05:27Z","timestamp":1783379127000},"source":"Crossref","is-referenced-by-count":0,"title":["Diagnostic accuracy and acceptability of self- and health worker-collected tongue swabs for\n                  <i>Mycobacterium tuberculosis<\/i>\n                  complex detection in adults in South Africa"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1590-198X","authenticated-orcid":false,"given":"Anura","family":"David","sequence":"first","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yeonsoo","family":"Baik","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Scott","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Griffiths","family":"Kubeka","sequence":"additional","affiliation":[{"name":"The Aurum Institute for Health Research, Parktown, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adelaide","family":"Benoit","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Public Health, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyndel","family":"Singh","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Wits Health Consortium (PTY) Ltd, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"da Silva","sequence":"additional","affiliation":[{"name":"National Priority Programmes, National Health Laboratory Services, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Stevens","sequence":"additional","affiliation":[{"name":"Wits Diagnostics Innovation Hub, Health Sciences Research Office, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa"},{"name":"National Priority Programmes, National Health Laboratory Services, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory P.","family":"Bisson","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salome","family":"Charalambous","sequence":"additional","affiliation":[{"name":"The Aurum Institute for Health Research, Parktown, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2026070810500962000_2026.07.04.26357275v1.1","unstructured":"Global Tuberculosis Report 2025. 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