Academic Journal
Diagnostic Accuracy of Molecular Testing on Saliva and Oral Swabs for Pulmonary Tuberculosis.
| Title: | Diagnostic Accuracy of Molecular Testing on Saliva and Oral Swabs for Pulmonary Tuberculosis. |
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| Authors: | Vargas DA; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.; Universidad Icesi, Cali, Colombia., Fuertes-Bucheli JF; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.; Departamento de Ciencias Básicas Médicas, Facultad de Ciencias de la Salud, Universidad Icesi, Cali, Colombia., Sanchez-Hidalgo A; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia., Palomares Velosa J; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia., Lasso AM; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.; Universidad Icesi, Cali, Colombia., Gupta AJ; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA., Martinez-Valencia AJ; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.; Universidad Icesi, Cali, Colombia.; Centro de Investigaciones Clínicas, Fundación Valle del Lili, Cali, Colombia.; Servicio de Enfermedades Infecciosas, Fundación Valle del Lili, Cali, Colombia., Díaz G; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia., Luna L; Programa de TB y VIH, Secretaría de Salud Distrital, Cali, Colombia., Alexander N; Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.; Universidad Icesi, Cali, Colombia., Ferro BE; Departamento de Ciencias Básicas Médicas, Facultad de Ciencias de la Salud, Universidad Icesi, Cali, Colombia., Davis JL; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.; Section of Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, Connecticut, USA. |
| Source: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2026 Jul 08; Vol. 82 (6), pp. e1313-e1321. |
| Publication Type: | Journal Article; Research Support, N.I.H., Extramural |
| Language: | English |
| Journal Info: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| Imprint Name(s): | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| MeSH Terms: | Saliva*/microbiology , Tuberculosis, Pulmonary*/diagnosis , Tuberculosis, Pulmonary*/microbiology , Mycobacterium tuberculosis*/isolation & purification , Mycobacterium tuberculosis*/genetics , Molecular Diagnostic Techniques*/methods, Sputum/microbiology ; Specimen Handling/methods ; Humans ; Female ; Male ; Adult ; Sensitivity and Specificity ; Case-Control Studies ; Prospective Studies ; Colombia ; Middle Aged ; Child ; Adolescent ; Young Adult ; Aged ; Rapid Diagnostic Tests |
| Abstract: | Background: Rapid, accurate, nonsputum tests are needed to close gaps in tuberculosis (TB) detection. We evaluated the diagnostic performance of molecular testing on saliva and oral swabs. Methods: We conducted a nested case-control study with 1:1 incidence-density sampling within a prospective cohort of adults and children undergoing evaluation for pulmonary TB at primary care centers in Colombia (July 2023-August 2024). Participants provided a sputum sample for liquid mycobacterial culture and paired saliva and nylon-flocked oral swabs for storage at -80°C. A microbiologist blinded to clinical and culture data performed Xpert MTB/RIF Ultra on thawed saliva and on swab eluate, each mixed 1:1 with sample reagent. We calculated the sensitivity and specificity of saliva and swab against sputum culture and compared them using McNemar's test. Results: Among 648 enrolled participants, we tested saliva and swabs from all 95 individuals with culture-confirmed TB and 95 matched culture-negative controls (n = 190). Saliva sensitivity was 90.5% (95% confidence interval [CI], 82.8-95.6), and specificity was 95.8% (95% CI, 89.6-98.8). Swab sensitivity was 71.6% (95% CI, 61.4-80.4), and specificity was 99% (95% CI, 94.3-100). Saliva sensitivity exceeded that of swab by an absolute difference of 18.9% (95% CI, +10.0 to +27.9, P < .001), but there was no significant difference in specificity (-3.2%, 95% CI, -7.7 to +1.4, P = .25). Over 95% of participants found saliva and swab collection procedures acceptable. Conclusions: Both saliva and swabs were highly sensitive and specific for culture-confirmed pulmonary TB. Saliva sensitivity exceeded the World Health Organization's ≥80% target for a low-complexity, nonsputum TB diagnostic test. (© The Author(s) 2026. Published by Oxford University Press on behalf of Infectious Diseases Society of America.) |
| Competing Interests: | Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. |
| Grant Information: | R21AI174129 National Institute of Allergy and Infectious Diseases at the US National Institutes of Health; D43TW006589 Fogarty International Center of the National Institutes of Health |
| Contributed Indexing: | Keywords: Mycobacterium tuberculosis; Colombia; molecular diagnostic techniques; sensitivity and specificity; tuberculosis |
| Entry Date(s): | Date Created: 20260312 Date Completed: 20260708 Latest Revision: 20260726 |
| Update Code: | 20260726 |
| PubMed Central ID: | PMC13341261 |
| DOI: | 10.1093/cid/ciag055 |
| PMID: | 41817395 |
| Database: | MEDLINE |
| ISSN: | 1537-6591 |
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| DOI: | 10.1093/cid/ciag055 |