Tuberculosis
Conditions
Interventions
Gold Standard:Mycobacterium tuberculosis culture and Xpert
Clinical diagnostic reference standard: *Health Industry Standard of the People's Republic of China: Diagnosis of Pulmonary Tuberculosis (
Index test:A highly sensitive diagnostic system for Mycobacterium tuberculosis, namely NuRapid Detection Analyzer (NDA-TB), has been developed based on the CRISPR-Cas system.
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
No minimum to 100 Years
Inclusion criteria
Inclusion criteria: 1. Any age, any gender; 2. Patients suspected of having tuberculosis according to the subject's clinical manifestations (such as cough and sputum > 2 weeks, low-grade fever in the afternoon, night sweats, etc.), laboratory tests (TST, IGRA, etc.) and imaging test results (such as chest X-ray or CT); 3. If condition 2 is not met), it is necessary to be a close contact of a bacteriological confirmed tuberculosis patient, and complete chest CT and blood IGRA testing 4. Receiving antimycobacterial drug treatment for less than 7 days; 5. No form of anti-tuberculosis therapy in the past 3 months.
Exclusion criteria
Exclusion criteria: 1. The subject or his/her guardian is unable to sign the informed consent form or withdraw the informed consent form midway; 2. The test sample is insufficient to complete the test or the test is unsuccessful (contamination, error report, etc.); 3. No Xpert test results available (within 7 days of sampling date); 4. Unable to obtain clear clinical diagnosis results;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactYang Yang
Shanghai Public Health Clinical Center
Outcome results
None listed