Academic Journal
Diagnostic accuracy of tongue swab testing in persons with sputum Xpert Ultra Trace results.
| Τίτλος: | Diagnostic accuracy of tongue swab testing in persons with sputum Xpert Ultra Trace results. |
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| Συγγραφείς: | Shapiro AE; Department of Global Health, University of Washington, Seattle, Washington, USA.; Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.; Department of Epidemiology, University of Washington, Seattle, Washington, USA., Dalmat RR; Department of Global Health, University of Washington, Seattle, Washington, USA., Mukwatamundu J; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Kamoga C; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Ngwane MW; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa., Steadman A; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Budiawan E; Department of Global Health, University of Washington, Seattle, Washington, USA., Stein G; Department of Global Health, University of Washington, Seattle, Washington, USA., Nalutaaya A; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Mukiibi J; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Nantale M; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda., Biché P; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Visek C; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Sung J; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Magcaba Z; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa., Ngcobo N; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa., Morton JF; Department of Global Health, University of Washington, Seattle, Washington, USA., Lenn M; Department of Global Health, University of Washington, Seattle, Washington, USA., Aucock S; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa., Draper R; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Ganguloo A; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Wilson D; Umkhuseli Innovation and Research Management, Pietermaritzburg, South Africa.; Department of Internal Medicine, Harry Gwala Regional Hospital, University of KwaZulu-Natal, Pietermaritzburg, South Africa., Katamba A; Uganda Tuberculosis Implementation Research Consortium, Walimu, Kampala, Uganda.; Clinical Epidemiology & Biostatistics Unit, Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda., Kendall EA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Drain PK; Department of Global Health, University of Washington, Seattle, Washington, USA.; Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.; Department of Epidemiology, University of Washington, Seattle, Washington, USA. |
| Πηγή: | MedRxiv : the preprint server for health sciences [medRxiv] 2025 Jul 16. Date of Electronic Publication: 2025 Jul 16. |
| Τύπος έκδοσης: | Journal Article; Preprint |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Country of Publication: United States NLM ID: 101767986 Publication Model: Electronic Cited Medium: Internet NLM ISO Abbreviation: medRxiv Subsets: PubMed not MEDLINE |
| Περίληψη: | Background: Molecular amplification of tongue swab samples is a non-sputum-based investigational approach to diagnose pulmonary tuberculosis (pTB). An improved manual qPCR method for tongue swabs recently achieved >90% sensitivity overall in diagnosing TB, compared to a sputum microbiologic reference standard. Performance characteristics in persons with low-positive results on sputum molecular tests are unknown. Methods: Adults in South Africa and Uganda with sputum Xpert MTB/RIF Ultra Trace (TR+) results were recruited for confirmatory evaluation and follow-up. They underwent symptom evaluation, examination, chest X-ray, further sputum testing (repeat Xpert Ultra and two solid and liquid mycobacterial cultures), and two tongue swabs. Tongue swabs were tested using qPCR amplification of the IS6110 gene. A single copy detected on >=1 swab was considered TB-positive. TR+ persons not diagnosed with TB at baseline were re-evaluated at 1 and 3 months. We determined the sensitivity and specificity of tongue swabs against TB culture alone, a microbiologic reference standard (MRS: any positive result from Xpert Ultra or TB culture) and a composite reference standard (CRS: a clinical recommendation for TB treatment or any positive culture) at baseline. Results: 225 enrolled TR+ participants (115 (51%) women, median age 38 [IQR 30-47], 130 (58%) people living with HIV (PWH)) provided at least 1 tongue swab at baseline. With a culture reference standard, 45 (20%) were positive for TB at baseline testing; 58 (26%) were positive for TB by MRS and 83 (37%) by CRS. Sensitivity and specificity of tongue swabs against culture were 25% [95% CI 13-40%] and 94% [90-97%], vs. MRS were 25% [95% CI 14-38%] and 96% [91-98%], and vs. CRS were 16% [9-26%] and 94% [89-98%]. Conclusion: Tongue swabs had low sensitivity and moderately high specificity for TB in persons with a Trace Xpert Ultra result. Tongue swabs have limited value for diagnosing people with low-positive molecular test results of uncertain clinical significance. |
| Competing Interests: | AES has received funding from Merck to her institution as a clinical trials investigator. PKD reports receiving research funding, paid to his institution, from the US National Institutes of Health, US Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation, Abbott Laboratories, and InBios International; and scientific advisory board (SAB) and/or consulting fees from Abbott Diagnostics, Abbvie, Cepheid, InBios International, PATH, OraSure, Revvity, Roche and Quidel. All authors declare no conflicts of interest. |
| References: | Clin Infect Dis. 2024 Mar 20;78(3):723-729. (PMID: 37787077) Clin Infect Dis. 2024 May 15;78(5):1313-1320. (PMID: 38306491) Lancet Glob Health. 2024 Jan;12(1):e45-e54. (PMID: 38097297) Lancet Glob Health. 2024 Jul;12(7):e1184-e1191. (PMID: 38876764) Clin Infect Dis. 2026 Feb 9;82(1):49-57. (PMID: 40705837) J Clin Microbiol. 2022 Jul 20;60(7):e0042122. (PMID: 35758702) Cochrane Database Syst Rev. 2021 Feb 22;2:CD009593. (PMID: 33616229) Clin Infect Dis. 2026 Mar 20;:. (PMID: 41858248) |
| Grant Information: | K23 AI185268 United States AI NIAID NIH HHS; R01 HL153611 United States HL NHLBI NIH HHS |
| Entry Date(s): | Date Created: 20250812 Date Completed: 20250914 Latest Revision: 20260322 |
| Update Code: | 20260322 |
| PubMed Central ID: | PMC12338924 |
| DOI: | 10.1101/2025.07.15.25331566 |
| PMID: | 40791694 |
| Βάση Δεδομένων: | MEDLINE |
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