{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T17:16:53Z","timestamp":1789579013646,"version":"build-2803163510"},"posted":{"date-parts":[[2025,7,16]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":11,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2025,7,16]],"date-time":"2025-07-16T00:00:00Z","timestamp":1752624000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2025,7,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Molecular amplification of tongue swab samples is a non-sputum-based investigational approach to diagnose pulmonary tuberculosis (pTB). An improved manual qPCR method for tongue swabs recently achieved &gt;90% sensitivity overall in diagnosing TB, compared to a sputum microbiologic reference standard. Performance characteristics in persons with low-positive results on sputum molecular tests are unknown.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Adults in South Africa and Uganda with sputum Xpert MTB\/RIF Ultra Trace (TR+) results were recruited for confirmatory evaluation and follow-up. They underwent symptom evaluation, examination, chest X-ray, further sputum testing (repeat Xpert Ultra and two solid and liquid mycobacterial cultures), and two tongue swabs. Tongue swabs were tested using qPCR amplification of the IS6110 gene. A single copy detected on &gt;=1 swab was considered TB-positive. TR+ persons not diagnosed with TB at baseline were re-evaluated at 1 and 3 months. We determined the sensitivity and specificity of tongue swabs against TB culture alone, a microbiologic reference standard (MRS: any positive result from Xpert Ultra or TB culture) and a composite reference standard (CRS: a clinical recommendation for TB treatment or any positive culture) at baseline.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>225 enrolled TR+ participants (115 (51%) women, median age 38 [IQR 30-47], 130 (58%) people living with HIV (PWH)) provided at least 1 tongue swab at baseline. With a culture reference standard, 45 (20%) were positive for TB at baseline testing; 58 (26%) were positive for TB by MRS and 83 (37%) by CRS. Sensitivity and specificity of tongue swabs against culture were 25% [95% CI 13-40%] and 94% [90-97%], vs. MRS were 25% [95% CI 14-38%] and 96% [91-98%], and vs. CRS were 16% [9-26%] and 94% [89-98%].<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Tongue swabs had low sensitivity and moderately high specificity for TB in persons with a Trace Xpert Ultra result. Tongue swabs have limited value for diagnosing people with low-positive molecular test results of uncertain clinical significance.<\/jats:p>\n                <\/jats:sec>","DOI":"10.1101\/2025.07.15.25331566","type":"posted-content","created":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:40:21Z","timestamp":1752712821000},"source":"Crossref","is-referenced-by-count":6,"title":["Diagnostic accuracy of tongue swab testing in persons with sputum Xpert Ultra Trace results"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3106-1258","authenticated-orcid":false,"given":"Adrienne E.","family":"Shapiro","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6959-0817","authenticated-orcid":false,"given":"Ronit R","family":"Dalmat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Job","family":"Mukwatamundu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caleb","family":"Kamoga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M William","family":"Ngwane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5605-1240","authenticated-orcid":false,"given":"Amy","family":"Steadman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvira","family":"Budiawan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabrielle","family":"Stein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3903-303X","authenticated-orcid":false,"given":"Annet","family":"Nalutaaya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Mukiibi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Nantale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2542-1113","authenticated-orcid":false,"given":"Patrick","family":"Bich\u00e9","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-5132-2092","authenticated-orcid":false,"given":"Caitlin","family":"Visek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4726-9651","authenticated-orcid":false,"given":"Joowhan","family":"Sung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zanele","family":"Magcaba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nompumelelo","family":"Ngcobo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer F.","family":"Morton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meena","family":"Lenn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Aucock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin","family":"Draper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Ganguloo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7756-8660","authenticated-orcid":false,"given":"Douglas","family":"Wilson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2347-4183","authenticated-orcid":false,"given":"Achilles","family":"Katamba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0083-422X","authenticated-orcid":false,"given":"Emily A","family":"Kendall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9569-4097","authenticated-orcid":false,"given":"Paul K","family":"Drain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2025071814001242000_2025.07.15.25331566v1.1","unstructured":"WHO. 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