{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T01:39:33Z","timestamp":1772156373270,"version":"3.50.1"},"posted":{"date-parts":[[2023,10,10]]},"group-title":"Infectious Diseases (except HIV\/AIDS)","reference-count":26,"publisher":"openRxiv","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2023,10,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:p>\n                  Tongue dorsum swabbing is a potential alternative to sputum collection for tuberculosis (TB) testing. Previous studies showed that Cepheid Xpert\u00ae MTB\/RIF Ultra (Xpert Ultra) can detect\n                  <jats:italic>Mycobacterium tuberculosis<\/jats:italic>\n                  (MTB) DNA in tongue swabs stored in buffer, with 72% sensitivity and 100% specificity relative to a sputum microbiological reference standard (sputum MRS). The present study evaluated a more convenient sample collection protocol (dry swab storage), combined with streamlined sample processing protocols, for side-by-side analysis using two commercial TB diagnostic tests: Xpert Ultra and Molbio Truenat\u00ae MTB Ultima (MTB Ultima). Copan FLOQSwabs were self-collected, or collected by study workers, from 321 participants in Western Cape, South Africa. All participants had symptoms suggestive of TB, and 245 of them had sputum MRS-confirmed TB (by sputum culture and\/or Xpert Ultra). One tongue swab per participant was tested on Xpert Ultra and another tongue swab was tested with MTB Ultima. Xpert Ultra was 75.4% sensitive and 100% specific, and MTB Ultima was 71.6% sensitive and 96.9% specific, relative to sputum MRS. When sample lysates that were false-negative by MTB Ultima were frozen, thawed, and re-tested, MTB Ultima sensitivity rose to 79.1%. Both tests were more sensitive with swabs from participants with higher sputum Xpert semi-quantitative results. The protocol for Xpert Ultra enabled fast and easy testing of dry-stored swabs with no loss of accuracy relative to previous methods. MTB Ultima testing of dry-stored swabs exhibited comparable performance to Xpert Ultra. These results further support tongue swabs as easy-to-collect samples for high-throughput TB testing.\n                <\/jats:p>","DOI":"10.1101\/2023.10.10.23296833","type":"posted-content","created":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T22:45:16Z","timestamp":1696977916000},"source":"Crossref","is-referenced-by-count":2,"title":["Tongue swab testing on two automated tuberculosis diagnostic platforms, Cepheid Xpert\u00ae MTB\/RIF Ultra and Molbio Truenat\u00ae MTB Ultima"],"prefix":"10.64898","author":[{"given":"Rachel C.","family":"Wood","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelique K.","family":"Luabeya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rane B.","family":"Dragovich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alaina M.","family":"Olson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherine A.","family":"Lochner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kris M.","family":"Weigel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ren\u00e9e","family":"Codsi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Humphrey","family":"Mulenga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaretha","family":"de Vos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mikashmi","family":"Kohli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Penn-Nicholson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Hatherill","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerard A.","family":"Cangelosi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"key":"2023101407501668000_2023.10.10.23296833v2.1","unstructured":"World Health Organization. 2022. Global Tuberculosis Report 2022"},{"key":"2023101407501668000_2023.10.10.23296833v2.2","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1038\/s41564-023-01365-3","article-title":"Transforming tuberculosis diagnosis","volume":"8","year":"2023","journal-title":"Nat Microbiol"},{"key":"2023101407501668000_2023.10.10.23296833v2.3","unstructured":"Branigan D. 2022. 2022 Tuberculosis Diagnostics Pipeline Report. Treatment Action Group, New York, NY"},{"key":"2023101407501668000_2023.10.10.23296833v2.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01379-X"},{"key":"2023101407501668000_2023.10.10.23296833v2.5","doi-asserted-by":"crossref","first-page":"e0262123","DOI":"10.1371\/journal.pone.0262123","article-title":"Diagnostic performance of oral swabs for non-sputum based TB diagnosis in a TB\/HIV endemic setting","volume":"17","year":"2022","journal-title":"PLoS One"},{"key":"2023101407501668000_2023.10.10.23296833v2.6","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00421-22:e0042122"},{"key":"2023101407501668000_2023.10.10.23296833v2.7","doi-asserted-by":"crossref","first-page":"e0043122","DOI":"10.1128\/jcm.00431-22","article-title":"Complementary Nonsputum Diagnostic Testing for Tuberculosis in People with HIV Using Oral Swab PCR and Urine Lipoarabinomannan Detection","volume":"60","year":"2022","journal-title":"J Clin Microbiol"},{"key":"2023101407501668000_2023.10.10.23296833v2.8","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0251422"},{"key":"2023101407501668000_2023.10.10.23296833v2.9","first-page":"e01847","article-title":"Noninvasive Detection of Tuberculosis by Oral Swab Analysis","volume":"57","year":"2019","journal-title":"Journal of Clinical Microbiology"},{"key":"2023101407501668000_2023.10.10.23296833v2.10","doi-asserted-by":"crossref","first-page":"10789","DOI":"10.1038\/s41598-019-47302-5","article-title":"Microbiological diagnosis of pulmonary tuberculosis in children by oral swab polymerase chain reaction","volume":"9","year":"2019","journal-title":"Scientific Reports"},{"key":"2023101407501668000_2023.10.10.23296833v2.11","doi-asserted-by":"crossref","unstructured":"Wood RC , Luabeya AK , Weigel KM , Wilbur AK , Jones-Engel L , Hatherill M , Cangelosi GA . 2015. Detection of Mycobacterium tuberculosis DNA on the oral mucosa of tuberculosis patients. Sci Rep 5.","DOI":"10.1038\/srep08668"},{"key":"2023101407501668000_2023.10.10.23296833v2.12","doi-asserted-by":"crossref","unstructured":"Flores JA , Calderon R , Mesman AW , Soto M , Coit J , Aliaga J , Mendoza M , Leon SR , Konda K , Mestanza FM , Mendoza CJ , Lecca L , Murray MB , Holmberg RC , Pollock NR , Franke MF . 2020. Detection of Mycobacterium Tuberculosis DNA in Buccal Swab Samples from Children in Lima, Peru. The Pediatric Infectious Disease Journal 39.","DOI":"10.1097\/INF.0000000000002828"},{"key":"2023101407501668000_2023.10.10.23296833v2.13","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1186\/s13104-019-4385-y","article-title":"Mycobacterium tuberculosis detection from oral swabs with Xpert MTB\/RIF ULTRA: a pilot study","volume":"12","year":"2019","journal-title":"BMC Res Notes"},{"key":"2023101407501668000_2023.10.10.23296833v2.14","doi-asserted-by":"publisher","DOI":"10.1101\/2023.08.10.23293680:2023.08.10.23293680"},{"key":"2023101407501668000_2023.10.10.23296833v2.15","doi-asserted-by":"crossref","first-page":"89","DOI":"10.2147\/IDR.S284157","article-title":"Diagnostic Yield of Oral Swab Testing by TB-LAMP for Diagnosis of Pulmonary Tuberculosis","volume":"14","year":"2021","journal-title":"Infection and drug resistance"},{"key":"2023101407501668000_2023.10.10.23296833v2.16","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.3781639"},{"key":"2023101407501668000_2023.10.10.23296833v2.17","doi-asserted-by":"crossref","first-page":"100148","DOI":"10.1016\/j.jctube.2020.100148","article-title":"Oral swab testing by Xpert MTB\/RIF Ultra for mass tuberculosis screening in prisons","volume":"19","year":"2020","journal-title":"Journal of Clinical Tuberculosis and Other Mycobacterial Diseases"},{"key":"2023101407501668000_2023.10.10.23296833v2.18","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.02360-20:JCM.02360-20"},{"key":"2023101407501668000_2023.10.10.23296833v2.19","doi-asserted-by":"crossref","first-page":"e0001430","DOI":"10.1371\/journal.pgph.0001430","article-title":"Preferences of healthcare workers using tongue swabs for tuberculosis diagnosis during COVID-19","volume":"3","year":"2023","journal-title":"PLOS Global Public Health"},{"key":"2023101407501668000_2023.10.10.23296833v2.20","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciac332"},{"key":"2023101407501668000_2023.10.10.23296833v2.21","unstructured":"Luabeya AK , Olson AM , As DV , Peterson C , Hadley K , Wood RC , Mambwe S , Mulenga H , Yan A , Yager P , Hatherill M , Cangelosi GA . Effects of oral hygiene and food intake on oral swab qPCR results in South African tuberculosis patients. Union World Conference on Lung Health 2022."},{"key":"2023101407501668000_2023.10.10.23296833v2.22","doi-asserted-by":"crossref","unstructured":"Xin Y , Xie J , Nan B , Tang C , Xiao Y , Wu Q , Lin Y , Zhang X , Shen H. 2021. Freeze-Thaw Pretreatment Can Improve Efficiency of Bacterial DNA Extraction From Meconium. Frontiers in Microbiology 12.","DOI":"10.3389\/fmicb.2021.753688"},{"key":"2023101407501668000_2023.10.10.23296833v2.23","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02171-10"},{"key":"2023101407501668000_2023.10.10.23296833v2.24","doi-asserted-by":"crossref","first-page":"3653","DOI":"10.1038\/s41598-017-03930-3","article-title":"XtracTB Assay, a Mycobacterium tuberculosis molecular screening test with sensitivity approaching culture","volume":"7","year":"2017","journal-title":"Sci Rep"},{"key":"2023101407501668000_2023.10.10.23296833v2.25","doi-asserted-by":"crossref","first-page":"e0007421","DOI":"10.1128\/JCM.00074-21","article-title":"Diagnosing Pulmonary Tuberculosis by Using Sequence-Specific Purification of Urine Cell-Free DNA","volume":"59","year":"2021","journal-title":"J Clin Microbiol"},{"key":"2023101407501668000_2023.10.10.23296833v2.26","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2016321"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1101\/2023.10.10.23296833","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T19:42:51Z","timestamp":1768506171000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.1101\/2023.10.10.23296833"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,10]]},"references-count":26,"URL":"https:\/\/doi.org\/10.1101\/2023.10.10.23296833","relation":{"has-review":[{"id-type":"doi","id":"10.1162\/2e3983f5.b48d2aa3","asserted-by":"object"},{"id-type":"doi","id":"10.1162\/2e3983f5.565ff2c9","asserted-by":"object"},{"id-type":"doi","id":"10.1162\/2e3983f5.f3955084","asserted-by":"object"},{"id-type":"doi","id":"10.1162\/2e3983f5.05d887d4","asserted-by":"object"},{"id-type":"doi","id":"10.1162\/2e3983f5.150a6e8a","asserted-by":"object"}]},"subject":[],"published":{"date-parts":[[2023,10,10]]},"subtype":"preprint"}}