{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T20:02:37Z","timestamp":1791576157026,"version":"4.3.4"},"posted":{"date-parts":[[2025,7,10]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":18,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2025,7,10]],"date-time":"2025-07-10T00:00:00Z","timestamp":1752105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2025,7,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Tongue swabs are a promising specimen for tuberculosis (TB) diagnosis. In a previous study using a consensus protocol, tongue swabs tested with Xpert MTB\/RIF Ultra (Xpert Ultra, Cepheid, USA) outperformed sputum smear microscopy, but a substantial proportion (6.1%) of results were non-actionable (e.g., invalid\/error). We evaluated a revised protocol in four high TB burden countries.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants aged \u226512 years with presumptive TB were enrolled from outpatient clinics in the Philippines, South Africa, Nigeria, and Zambia. Tongue swabs were processed using Sample Reagent (SR, Cepheid, USA) diluted 2:1 with phosphate buffer or phosphate-buffered saline and tested with Xpert Ultra. Diagnostic performance was assessed against a culture-based microbiological reference standard and compared to sputum-based tests.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From March to November 2024, 1168 participants were enrolled (median age 37 [IQR 28\u2013 48] years; 46.7% female, 21.8% living with HIV, 18.5% culture-confirmed TB). The proportion of non-actionable results was 5.6% overall, but was less than 4% in all countries except South Africa (15.4%). Tongue swab sensitivity was 66.0% (95% CI 59.0\u201372.5); specificity was 99.6% (95% CI98.9\u201399.9).<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The revised protocol yielded low error rates at most sites and moderate sensitivity, supporting tongue swabs as an alternative when sputum is unavailable.<\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2025.07.08.25330424","type":"posted-content","created":{"date-parts":[[2025,7,10]],"date-time":"2025-07-10T21:40:14Z","timestamp":1752183614000},"source":"Crossref","is-referenced-by-count":4,"title":["Tongue Swab Xpert MTB\/RIF Ultra Testing for Tuberculosis Using a Revised Consensus Protocol: A multi-country diagnostic accuracy study"],"prefix":"10.64898","author":[{"given":"Bukola","family":"Ajide","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9318-2514","authenticated-orcid":false,"given":"Caitlin A.","family":"Moe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4744-7133","authenticated-orcid":false,"given":"Jheannie","family":"Barrameda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6036-7320","authenticated-orcid":false,"given":"Masuzyo","family":"Chirwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7882-2157","authenticated-orcid":false,"given":"Loren","family":"Rockman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"de Haas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaretha","family":"de Vos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0539-2472","authenticated-orcid":false,"given":"Midori","family":"Kato-Maeda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0737-8052","authenticated-orcid":false,"given":"Bianca","family":"Tasca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Bimba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia M.","family":"Denkinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-1729-5463","authenticated-orcid":false,"given":"Kristin","family":"Kremer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2811-1311","authenticated-orcid":false,"given":"Payam","family":"Nahid","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6553-2601","authenticated-orcid":false,"given":"Adithya","family":"Cattamanchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9216-2415","authenticated-orcid":false,"given":"Grant","family":"Theron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3609-5403","authenticated-orcid":false,"given":"Monde","family":"Muyoyeta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the R2D2 TB Network","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2025071203250992000_2025.07.08.25330424v1.1","unstructured":"World Health Organization. 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