Tuberculosis
Conditions
Interventions
Gold Standard:ELISA Testing (Ag85B,etc.)
Index test:Multifunctional Portable/Wearable Biosensing Electronic System testing Ag85, etc.
Sponsors
West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Tuberculosis Group Inclusion Criteria: A confirmed case meets any of the following conditions: sputum smear-positive pulmonary tuberculosis; culture-positive pulmonary tuberculosis; pulmonary imaging consistent with active pulmonary tuberculosis; positive molecular biological testing; pathological diagnosis of tuberculosis lesions in lung or pleural specimens. Latent Tuberculosis Inclusion Criteria: Individuals aged 18–80 years who are family members of active TB patients or have a history of exposure to active TB, with positive TB-IGRA, PPD, or T-SPOT® test results, and no clinical, bacteriological, or radiological evidence of active TB, or who are clinically diagnosed with latent tuberculosis following assessment by a clinician. 2. Healthy control group inclusion criteria: Negative r-interferon release assay, no prior history of tuberculosis, absence of tuberculosis-related clinical symptoms, and normal chest X-ray findings. No significant discomfort, no long-term medication use, and no underlying medical conditio
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients with mixed infections; patients with solid tumors or hematologic malignancies; critically ill patients with organ failure; severe autoimmune diseases, use of immunosuppressants or immunoenhancers; pregnancy or lactation; patients who refuse to sign informed consent.Inclusion Criteria for the Tuberculosis Group: Individuals meeting any of the following criteria are considered confirmed cases: smear-positive pulmonary tuberculosis; culture-positive pulmonary tuberculosis; chest imaging findings consistent with active pulmonary tuberculosis; positive molecular biology test results; pathological diagnosis of tuberculosis from lung or pleural lesion specimens; and no prior history of antituberculosis treatment. Inclusion Criteria for the Healthy Control Group: Negative interferon-gamma release assay, no history of tuberculosis, absence of tuberculosis-related clinical symptoms, and normal chest X-ray findings. No significant discomfort, no long-term medication use, and no underlying medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ag85B in Exhaled breath condensate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Specificity;Sensitivity;Accuracy; | — |
Countries
China
Contacts
Public ContactBinwu Ying
West China Hospital
Outcome results
None listed