ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024
New Manual Quantitative Polymerase Chain Reaction Assay Validated on Tongue Swabs Collected and Processed in Uganda Shows Sensitivity That Rivals Sputum-based Molecular Tuberculosis Diagnostics.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07293455 (Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3), which is not on this map. Cited by 32 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified
Who cites it
32 citing papers in PubMed.
- Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples.The New England journal of medicine · 2026Trial
- Diagnostic Performance of the Pluslife MiniDock MTB and Molbio MTB Ultima Assays to Detect Tuberculosis From Tongue and Sputum Swabs Among Outpatients and in Active Case Finding in Cameroon.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Centralized molecular testing of community-collected tongue swabs for tuberculosis screening among household contacts: a cross-sectional diagnostic performance, yield, and implementation study.medRxiv : the preprint server for health sciences · 2026Article
- Diagnostic Accuracy of Molecular Testing on Saliva and Oral Swabs for Pulmonary Tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Community-based chest X-ray screening versus symptom-based case presentation in the elderly: evidence from three consecutive years of data.BMC geriatrics · 2026Article
- Development of a Rapid Automated Point-of-Care Test formedRxiv : the preprint server for health sciences · 2026Article
- Preferences for tongue swab versus sputum collection for TB testing: a multi-country survey.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2026Article
- Targeting Tryptophan Metabolism for Tuberculosis Biomarkers and Host-Directed Therapy.The Journal of infectious diseases · 2026Review
- Tongue swabmedRxiv : the preprint server for health sciences · 2026Article
- Acceptability of tongue swabs for tuberculosis screening in migrant settings in northern Italy: A qualitative study.PLOS global public health · 2026Article
- Testing tongue swab samples by Cepheid Xpert MTB/RIF Ultra: comparison of two protocols applied to samples from persons with low-bacillary load TB.Microbiology spectrum · 2025Article
- Whom tuberculosis tests detect and why it matters: implications for diagnostic algorithms.The Lancet. Microbe · 2025Review
- Improving tuberculosis diagnosis: evaluation of tongue swabbing as a complementary method to sputum analysis in Guinea.Annals of clinical microbiology and antimicrobials · 2025Article
- Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation.EBioMedicine · 2025Article
- Importance of confirmatory test characteristics in optimizing community-based screening for tuberculosis: an epidemiological modeling analysis.BMC infectious diseases · 2025Article
- Sensitive pathogen DNA detection by a multi-guide RNA Cas12a assay favoring trans- versus cis-cleavage.Nature communications · 2025Article
- AveloMask, a novel breath aerosol collection kit for airborneJournal of clinical microbiology · 2025Article
- Diagnostic accuracy of tongue swab testing in persons with sputum Xpert Ultra Trace results.medRxiv : the preprint server for health sciences · 2025Article
- Cumulative TB disease burden following sputum Xpert Ultra 'Trace' results in clinical settings: Results from a multi-site observational clinical study.medRxiv : the preprint server for health sciences · 2025Article
- Patient experiences of tuberculosis treatment deferral after a trace Xpert Ultra result: a prospective cohort study.Infectious diseases of poverty · 2025Article
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Authors and funding
26 authors.
Funding
Abstract
backgroundSputum-based testing is a barrier to increasing access to molecular diagnostics for tuberculosis (TB). Many people with TB are unable to produce sputum, and sputum processing increases assay complexity and cost. Tongue swabs are emerging as an alternative to sputum, but performance limits are uncertain.
methodsFrom June 2022 to July 2023, we enrolled 397 consecutive adults with cough >2 weeks at 2 health centers in Kampala, Uganda. We collected demographic and clinical information, sputum for TB testing (Xpert MTB/RIF Ultra and 2 liquid cultures), and tongue swabs for same-day quantitative polymerase chain reaction (qPCR) testing. We evaluated tongue swab qPCR diagnostic accuracy versus sputum TB test results, quantified TB targets per swab, assessed the impact of serial swabbing, and compared 2 swab types (Copan FLOQSWAB and Steripack spun polyester).
resultsAmong 397 participants, 43.1% were female, median age was 33 years, 23.5% were diagnosed with human immunodeficiency virus, and 32.0% had confirmed TB. Sputum Xpert Ultra and tongue swab qPCR results were concordant for 98.2% (95% confidence interval [CI]: 96.2-99.1) of participants. Tongue swab qPCR sensitivity was 92.6% (95% CI: 86.5 to 96.0) and specificity was 99.1% (95% CI: 96.9 to 99.8) versus microbiological reference standard. A single tongue swab recovered a 7-log range of TB copies, with a decreasing recovery trend among 4 serial swabs. Swab types performed equivalently.
conclusionsTongue swabs are a promising alternative to sputum for molecular diagnosis of TB, with sensitivity approaching sputum-based molecular tests. Our results provide valuable insights for developing successful tongue swab-based TB diagnostics.
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