{
  "abstract": "BACKGROUND: Despite advancements in tuberculosis diagnostics, many cases remain unconfirmed because of challenges in conventional sputum-based testing. This study aimed to evaluate the diagnostic accuracy of tongue swab sampling as a non-invasive alternative for tuberculosis diagnosis using Xpert MTB/RIF Ultra (Ultra). METHODS: We conducted a large-scale, multicountry, prospective diagnostic accuracy study of Ultra using tongue swabs in people with presumptive pulmonary tuberculosis. Participants were enrolled consecutively at primary health centres and hospitals across eight countries from June 26, 2023, to Feb 15, 2024, and the study was coordinated by three consortia. Eligible participants were individuals aged 12 years or older or 18 years or older, according to the consortium involved, with presumptive pulmonary tuberculosis or at least one risk factor for tuberculosis and a positive tuberculosis screening test at the select consortia. Standardised tongue swab collection and processing protocols were used in all countries. Sensitivity and specificity with 95% CI values were calculated against sputum liquid or solid culture (primary) and sputum Ultra (secondary) reference standards using Wilson's score method. Fisher's exact tests were used for subgroup comparisons, with p values < 0·05 considered statistically significant. FINDINGS: Among the 1844 participants included in the analysis, 389 tested positive and 1455 tested negative for pulmonary tuberculosis based on the primary sputum culture reference standard. 871 (47·2%) participants were female and 973 (52·7%) were male, with a mean age of 43 years (range 12-90). Among the 1844 participants, 399 (21·7%) were enrolled in Viet Nam, 166 (9·0%) in India, 427 (23·2%) in South Africa, 271 (14·7%) in the Philippines, 138 (7·5%) in Nigeria, 102 (5·5%) in Zambia, 175 (9·5%) in Uganda, and 166 (9·0%) in Peru. Tongue swab Ultra testing showed a sensitivity of 65·6% (95% CI 60·6-70·3) and specificity of 98·5% (95% CI 97·7-99·1) against the culture-based reference standard. Sensitivity estimates varied across collection centres and were higher in individuals without HIV than in those living with HIV (68·4% vs 50·0%; absolute difference 18·4 percentage points [95% CI 3·3-33·4]). When sputum Ultra was used as the reference standard, sensitivity was 75·4% (95% CI 69·0-78·8). Tongue swab Ultra showed higher sensitivity than sputum smear microscopy. Invalid or error result rates were variable and high at certain sites (range 0-16%). INTERPRETATION: Tongue swabs are a promising sample type for rapid diagnostic tests for tuberculosis, with moderate sensitivity and high specificity when Ultra was used as the reference standard. However, further research is needed to optimise protocols for Ultra testing and develop assays tailored to tongue swab specimens. Adoption of tongue swab-based molecular testing could expand tuberculosis diagnostics access, especially for populations unable to produce sputum, thus supporting global tuberculosis elimination goals. FUNDING: National Institute of Allergy and Infectious Diseases, United States Agency for International Development.",
  "abstract_shown": true,
  "affiliations": [
    "FIND, Geneva, Switzerland",
    "University of California San Francisco - Viet Nam Tuberculosis Program (UCSF-VNTP), Hanoi, Viet Nam; Center for Promotion of Advancement of Society (CPAS), Hanoi, Viet Nam",
    "College of Medicine, De La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines",
    "Zankli Research Center, Bingham University, Karu, Nigeria",
    "Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru",
    "Medical University of South Carolina, Charleston, SC, USA",
    "Frontier Science Foundation, Brookline, MA, USA",
    "Vietnam National Lung Hospital, Hanoi, Viet Nam",
    "Division of Medical Microbiology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Division of Medical Microbiology, National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa",
    "Makerere University Biomedical Research Centre, Kampala, Uganda",
    "Department of Community Medicine, Christian Medical College, Vellore, India",
    "Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, CA, USA; Center for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA",
    "DST/NRF Centre of Excellence for Biomedical Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa; Division of Molecular Biology and Human Genetics, SA MRC Centre for Molecular and Cellular Biology, Tygerberg, South Africa",
    "Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia",
    "Division of Medical Microbiology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa",
    "College of Health Sciences, Makerere University, Kampala, Uganda",
    "Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Epidemiology, School of Public and Population Health, The University of Texas Medical Branch, Galveston, TX, USA",
    "Rutgers University New Jersey Medical School, Newark, NJ, USA",
    "Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany; German Center of Infection Research, partner site Heidelberg, Germany",
    "KNCV Tuberculosis Foundation, Hague, Netherlands",
    "Johns Hopkins University School of Medicine, Baltimore, MD, USA",
    "Center for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA",
    "Division of Pulmonary Diseases and Critical Care Medicine, University of California Irvine, Irvine, CA, USA; Center for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco, San Francisco, CA, USA. Electronic address: adithya.cattamanchi@ucsf.edu"
  ],
  "article_type": null,
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  "author_total": 100,
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      "name": "Nguyen Van Hung"
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        7
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      "name": "Dinh Van Luong"
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      "name": "Charles Yu"
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      "name": "David Alland",
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      "name": "Claudia Maria Denkinger",
      "orcid": "0000-0002-7216-7067"
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      "name": "Jerrold J. Ellner",
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      "name": "Susan E. Dorman",
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      "name": "Kristin Kremer",
      "orcid": "0009-0004-1729-5463"
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      "name": "Yukari Carol Manabe",
      "orcid": "0000-0001-8619-5598"
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      "name": "Payam Nahid",
      "orcid": "0000-0003-2811-1311"
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      "name": "Morten Rühwald",
      "orcid": "0000-0002-1597-441X"
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      "name": "M Shah",
      "orcid": "0000-0002-7374-2246"
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      "name": "Adam Penn‐Nicholson",
      "orcid": "0000-0002-1883-0059"
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      "name": "Adithya Cattamanchi",
      "orcid": "0000-0002-6553-2601"
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      "name": "John Bimba",
      "orcid": "0000-0001-7847-4271"
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      "name": "Alabi Alfa"
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    {
      "name": "Amritha Ravikumar"
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      "name": "Anathi Ngxakeni"
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      "name": "Angelita Pabruada"
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      "name": "Ankur Gupta‐Wright",
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      "name": "Chukwuma Anyaike",
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  "bibtex": "https://research.draconitic.com/paper/7w4awkmv2rb3t.bib",
  "cited_by": 13,
  "doi": "10.1016/j.lanmic.2025.101330",
  "fulltext_url": null,
  "id": "7w4awkmv2rb3t",
  "issns": [
    "2666-5247"
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  "landing_url": "https://doi.org/10.1016/j.lanmic.2025.101330",
  "language": "en",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
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  "native_subjects": [
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      "2725|Tuberculosis Research and Epidemiology"
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  "pmcid": "PMC13673448",
  "pmid": "42134368",
  "published": "2026-05-15",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/7w4awkmv2rb3t.ris",
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    {
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2725|Tuberculosis Research and Epidemiology",
      "subfield": "infectious-disease"
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  ],
  "title": "Multicountry assessment of tongue swabs for tuberculosis using a common protocol for Xpert MTB/RIF Ultra testing: a prospective diagnostic accuracy study",
  "title_text": "Multicountry assessment of tongue swabs for tuberculosis using a common protocol for Xpert MTB/RIF Ultra testing: a prospective diagnostic accuracy study",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T13:20:51Z",
  "url": "https://research.draconitic.com/paper/7w4awkmv2rb3t",
  "venue": "The Lancet Microbe",
  "versions": []
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