Tuberculosis
Conditions
Interventions
Gold Standard:1. Mycobacterium tuberculosis culture (Roche culture / liquid culture).2. Mycobacterium tuberculosis PCR test / sequencing test.3. Gamma-interferon release assay (such as T-SPOT.TB, QFT-
Index test:Results of the detection of tuberculosis antigen CFP-10/ESAT-6 established by nanotechnology
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Tuberculosis (TB) Group: Patients diagnosed with tuberculosis (including both pulmonary and extrapulmonary TB) based on clinical symptoms, imaging findings, and microbiological or pathological evidence, who had available peripheral blood samples (serum/plasma). Healthy Control Group: Healthy individuals with no history of tuberculosis or other infectious diseases, normal physical examination indicators, and available peripheral blood samples. Other Disease Control Group: Patients diagnosed with non-tuberculous pulmonary diseases (e.g., pneumonia, lung cancer, etc.), who had available peripheral blood samples.
Exclusion criteria
Exclusion criteria: 1.Exclusion criteria: Insufficient sample size (serum/plasma volume < 0.5mL) or improper sample preservation (such as repeated freezing and thawing, contamination); 2.incomplete clinical data (such as lack of diagnostic basis, missing key detection indicators). Withdrawal criteria: Subsequent discovery that sample information does not meet the inclusion criteria;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The content of two specific antigens of Mycobacterium tuberculosis, CFP-10/ESAT-6, in peripheral blood; ;the fluorescence intensity value of dual-channel enzyme-free fluorescence.; | — |
Countries
China
Contacts
Public ContactCHEN DONGJIE
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed