Tuberculosis
Conditions
Interventions
Gold Standard:The composite reference standard of mycobacterial culture and Xpert assay was used as the gold standard to assess the diagnostic accuracy of oral swab analysis.
Sponsors
Beijing Chest Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)18 years of age and older AND 2) Chest X-rays indicate active lesions or abnormalities AND 3) Present to the health centers for any reason, for cough, expectoration, hemoptysis, fatigue, weight loss, night sweats etc. AND 4) Clearly clinical diagnosis, including clinical characteristics, laboratory test results and other information.
Exclusion criteria
Exclusion criteria: 1) had completed latent or active TB treatment within the past 12 months OR 2) had taken medication with antimycobacterial activity (including fluoroquinolones) for any reason within 2 weeks of study entry OR 3) Women during pregnancy and lactation OR 4) Any extrapulmonary tuberculosis complicated with/without HIV OR 5) were unwilling or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate sensitivity and specificity for tongue swab analysis for suspected pulmonary tuberculosis in adults, with 95% confidence intervals; | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimate sensitivity and specificity for tongue swab analysis for conformed pulmonary tuberculosis in adults, with 95% confidence intervals;The success rate of tongue swab detection under different bacterial loads; | — |
Countries
China
Contacts
Public ContactYu Pang
Beijing Chest Hospital Affiliated to Capital Medical University
Outcome results
None listed