Oral Washes and Tongue Swabs for Xpert MTB/RIF Ultra–Based Tuberculosis Diagnosis in People With and Without the Ability to Make Sputum
Authors:
- Loren RockmanLRLoren Rockman
- Shima M AbdulgaderShima M Abdulgader
- Stephanie MinniesSMStephanie Minnies
- Charissa C NaidooCharissa C Naidoo
- Rouxjeane VenterRVRouxjeane Venter
- Daphne NaidooDaphne Naidoo
- Gcobisa NdlangalavuGNGcobisa Ndlangalavu
- Byron W P ReeveByron W P Reeve
- Andrew Medina-MarinoAndrew Medina-Marino
- Tim J BullTim J Bull
- Alaina M OlsonAOAlaina M Olson
Open Access
- 18 July 2025
- journal article
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 81 (6) , e632-e642
Abstract
Background: Oral samples show promise for tuberculosis (TB) diagnosis, but data from different sample types and sputum-scarce individuals remain limited. Methods: We evaluated Xpert MTB/RIF Ultra (Ultra) in symptomatic clinic attendees (cohort A, n = 891) and people initiating antiretroviral therapy without symptom screening (cohort B, n = 258). In cohort A, we collected oral washes (OWs) and, separately, tongue swabs (flocked or foam with heat). In cohort B, we collected OWs, 3 flocked tongue swabs (1 heated, 2 pooled), and, separately, buccal swabs and periodontal brushes. Sputum induction was offered, and different culture methods were applied to a subset of cohort B tongue swabs. Results: In cohort A, Ultra sensitivity was 80% (95% confidence interval [CI], 56%–94%) for OWs, 59% (95% CI, 53%–65%) for flocked swabs, and 65% (95% CI, 58%–72%) for foam swabs, with high specificity. Foam swabs detected more people with Ultra sputum semi-quantitation categories of low or less than flocked swabs (53% [95% CI, 41%–64%] vs 37% [95% CI, 29%–46%]). In cohort B, OWs and single heated swabs had sensitivities of 71% (95% CI, 42%–92%) and 64% (95% CI, 35%–87%), respectively. Pooled tongue swabs, buccal swabs, and brushes had lower sensitivity. MGIT960 showed the highest sensitivity (64% [95% CI, 35%–87%]) among culture methods. Oral sampling identified TB in sputum-scarce people: 25% (7/28) positive by flocked or foam swabs (cohort A); 18% (10/56) were OW and 23% (13/56) single swab positive (cohort B). In cohort B, this could double Ultra positivity if induction were unavailable. Conclusions: Ultra on OWs or foam swabs offers higher sensitivity than other oral methods and effectively detects TB in sputum-scarce individuals.Keywords
All Related Versions
Funding Information
- South African Medical Research Council
- National Research Foundation
This publication has 29 references indexed in Scilit:
- Trade-offs between clinical performance and test accessibility in tuberculosis diagnosis: a multi-country modelling approach for target product profile developmentThe Lancet Global Health, 2024
- Diagnostic yield as an important metric for the evaluation of novel tuberculosis tests: rationale and guidance for future researchThe Lancet Global Health, 2024
- Point-of-care C-reactive protein and Xpert MTB/RIF Ultra for tuberculosis screening and diagnosis in unselected antiretroviral therapy initiators: a prospective, cross-sectional, diagnostic accuracy studyThe Lancet Global Health, 2024
- Blood RNA biomarkers for tuberculosis screening in people living with HIV before antiretroviral therapy initiation: a diagnostic accuracy studyThe Lancet Global Health, 2024
- Oral swabs with a rapid molecular diagnostic test for pulmonary tuberculosis in adults and children: a systematic reviewThe Lancet Global Health, 2023
- Xpert MTB/RIF Ultra on contaminated liquid cultures for tuberculosis and rifampicin-resistance detection: a diagnostic accuracy evaluationThe Lancet Microbe, 2023
- Reimagining the status quo: How close are we to rapid sputum-free tuberculosis diagnostics for all?EBioMedicine, 2022
- Xpert MTB/RIF Ultra and Xpert MTB/RIF for diagnosis of tuberculosis in an HIV-endemic setting with a high burden of previous tuberculosis: a two-cohort diagnostic accuracy studyThe Lancet Respiratory Medicine, 2020
- Microbiological diagnosis of pulmonary tuberculosis in children by oral swab polymerase chain reactionScientific Reports, 2019
- Identification of M. tuberculosis ribosomal RNA in mouthwash samples from patients with tuberculosisRespiratory Medicine, 1994