tuberculous mycobacterium disease
Conditions
Interventions
Index test:High-throughput targeted sequencing based on Nanopore sequencing platform
Sponsors
Beijing Chest Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for pulmonary tuberculosis (including NTMPD): 1.1 Age = 18 years; 1.2 Presence of suspected tuberculosis symptoms, including fever, chest pain, chest tightness, cough, sputum production, or hemoptysis; 1.3 Radiographic evidence of pulmonary lesions, with specific characteristics meeting any of the following criteria: (a) cavitation, (b) bronchiectasis and nodules, (c) masses or scattered patchy ground-glass opacities, (d) patchy opacities in the lungs and bronchial spreading lesions, (e) other specific types such as "hot tub" lung, solitary nodules, etc.; 1.4 Follow-up patients meeting all of the following criteria simultaneously: (a) considered successful in initial treatment and completed the treatment course, (b) suspected recurrence of infection in patients, (c) follow-up diagnosis not yet confirmed or pathogen not clearly diagnosed; 1.5 Sample volume: sputum > 3ml; bronchoalveolar lavage fluid > 6ml; pleural tissue > 3ml; Signed informed consent form. 2. Inclusion criteria for extrapulmonary tuberculosis (including extrapulmonary NTM disease): 2.1 Age = 18 years; 2.2 Clinical diagnosis of tuberculous meningitis or pulmonary tuberculosis complicated with cerebral tuberculosis, with 2-3ml cerebrospinal fluid; 2.3 Clinical diagnosis of lymph node tuberculosis, with 3ml of aspirated content or pus; 2.4 Clinical diagnosis of bone tuberculosis, with 3ml of joint pus; 2.5 Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pathogen specimens that did not yield a sufficient sample size as expected; 2. Cases where imaging examinations, GeneXpert MTB/RIF testing, and diagnostic results could not be obtained; 3. Types of extrapulmonary tuberculosis other than cerebral tuberculosis, lymph node tuberculosis, and bone tuberculosis; 4. Unable to obtain informed consent; 5. Age less than 18 years old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical consistency of Nanopore sequencing in the primary diagnosis of tuberculosis;Clinical consistency of Nanopore sequencing to predictions of primary drug resistance to tuberculosis;Accuracy;Sensitivity;Specificity;Positive predicative value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical consistency of diagnosis results of non-tuberculous mycobacterium pathogens by Nanopore sequencing;Clinical consistency of Nanopore sequencing to predictions of primary drug resistance to non-tuberculous mycobacterium; | — |
Countries
China
Contacts
Public ContactPang Yu
Beijing Chest Hospital Affiliated to Capital Medical University
Outcome results
None listed