Browsing by Author "Le H"

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    Diagnostic Yield of Tongue Swab- Compared to Sputum-Based Molecular Testing for Tuberculosis in Four High-Burden Countries.
    (2026-Apr-30) Moe CA; Luswata RK; Barrameda AJ; Le H; Muzazu S; Crowder R; Andama AO; Denkinger CM; Muyoyeta M; Phan H; Cattamanchi A; Yu C
    BACKGROUND: Tongue swabs are a promising alternative specimen for tuberculosis (TB) diagnosis. Although test specificity exceeds 98%, sensitivity is lower than sputum-based molecular testing. We investigated whether the use of tongue swabs could increase sample availability, resulting in similar diagnostic yield. METHODS: In this cross-sectional study (July 2024-January 2025), we screened consecutive people with presumptive TB at health centers in the Philippines, Vietnam, Uganda, and Zambia. Participants were asked to provide tongue swabs and referred for routine sputum collection. Tongue swabs were tested in research laboratories using the MiniDock MTB Test (Guangzhou Pluslife Biotech Co., Ltd., China); sputum was tested using WHO-recommended molecular testing per national guidelines. We compared diagnostic yield, defined as proportion of positive test results among all participants, between tongue swab- and sputum-based molecular testing with a prespecified 3.0% non-inferiority margin. RESULTS: Of 1639 participants, 851 (51.9%) were female, 415 (25.3%) were diagnosed with HIV, and 132 (8.1%) were children <5 years. All provided tongue swabs, but only 1389 (84.7%) produced sputum. Diagnostic yield was 3.8% (63/1639) for tongue swabs and 4.1% (68/1639) for sputum-based (68/1639, 4.1%) molecular testing. The difference (0.3%, 95% CI -0.6 to +1.2) was within the prespecified non-inferiority margin. Results were consistent across countries and key subgroups (age, sex, and HIV status). CONCLUSIONS: Tongue swab-based molecular testing with MiniDock MTB achieved non-inferior diagnostic yield compared with sputum-based molecular testing. These findings support scale-up of swab-based platforms as a cost-efficient alternative, particularly where sputum collection is challenging or smear microscopy remains the primary diagnostic method.
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    Multicountry assessment of tongue swabs for tuberculosis using a common protocol for Xpert MTB/RIF Ultra testing: a prospective diagnostic accuracy study.
    (2026-May-14) de Vos M; Le H; Marcelo D; Ajide B; Alí-Francia KG; Borkman AL; Desravines R; Chang HT; Dowling W; Kamulegeya L; Marconi S; Moe CA; Rockman L; Shuma B; Christopher DJ; Hapeela N; Muyoyeta M; Nakiyingi L; Theron G; Ugarte-Gil C; Hung NV; Luong DV; Yu C; Alland D; Denkinger CM; Ellner J; Dorman SE; Kremer K; Manabe YC; Nahid P; Ruhwald M; Shah M; Penn-Nicholson A; Cattamanchi A; Bimba JS
    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.
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    Preferences for Tongue Swab versus Sputum Collection for Tuberculosis Testing: A Multi-Country Survey.
    (2025-Jul-05) Manoj Kumar K; Borkman A; Kim A; Crowder R; Ajide B; Alí-Francia K; Chirwa M; Kamulegeya L; Le H; Trung VN; Venter R; Bimba J; Christopher DJ; Dalay V; Van Hung N; Muyoyeta M; Nakiyingi L; Van Nhung N; Theron G; Yu C; Zamudio-Fuertes C; Atim J; Kerkhoff AD; Castro Noriega MDM; Nahid P; Denkinger CM; Cattamanchi A; Dorman SE; West N
    BACKGROUND: Sputum collection for tuberculosis (TB) diagnosis poses challenges for children, people living with HIV, and those who struggle with sputum production. Tongue swab-based molecular testing offers a promising non-invasive alternative, but person-centered research on acceptability is limited. METHODS: We conducted a pragmatic survey across eight countries (Vietnam, Philippines, South Africa, Nigeria, Zambia, India, Uganda, Peru) among people with presumptive TB attending primary care facilities. Participants provided both tongue swab and sputum samples, then completed a 5-10 minute survey about their collection preferences. RESULTS: From October 2023 to July 2024, 1,297 participants were enrolled (median age 43 years, 45% female, 13% HIV-positive). Overall, 61% (95% CI: 58-64%) preferred tongue swab collection compared to 22% (95% CI: 20-25%) who preferred sputum collection and 17% (95% CI: 15-19%) with no preference. Preference for tongue swab was consistent across demographic and clinical subgroups, with country-level variation ranging from 47% in South Africa to 74% in Zambia and Nigeria. CONCLUSION: Strong preference for tongue swab over sputum collection among individuals with presumptive TB supports this diagnostic innovation's potential to overcome barriers to timely TB testing, particularly for populations struggling with sputum production.