Tuberculosis disease
Conditions
Interventions
Gold Standard:The composite reference standard of mycobacterial culture and Xpert Ultra 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
Inclusion criteria
Inclusion criteria: 1. Cases with signs/symptoms of tuberculosis, suspected or confirmed tuberculosis patients, as well as cases of other diseases that are easily confused; 2. Cases with complete and traceable information; 3. Cases for which informed consent has been signed, or for which informed consent has been waived by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. Cases where sample collection, storage, or other procedures do not meet sample requirements; 2. Cases with insufficient sample size to complete the clinical trial testing; 3. Cases with incomplete documentation (must include at least a unique traceability number, age, sex, and clinical diagnosis); 4. Cases deemed unsuitable for enrollment in the clinical trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Concordance Rate;Negative concordance rate;Overall compliance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kappa Consistency Analysis; | — |
Countries
China
Contacts
Public ContactPang Yu
Beijing Chest Hospital Affiliated to Capital Medical University
Outcome results
None listed