tuberculosis
Conditions
Interventions
Gold Standard:The patient is considered to have tuberculosis based on the final clinical diagnosis or microbiological diagnosis as the gold standard, i.e., a clinical diagnosis of tuberculosis is tube
Index test:Ultra-sensitive Electrochemiluminescence Urine Lipoarabinomannan Assay,Urine LAM
Sponsors
Beijing Tuberculosis and Thoracic Tumor Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Inclusion Criteria for Adult Pulmonary Tuberculosis (Excluding Tuberculous Pleurisy) Samples A. Patients suspected of having tuberculosis in the tuberculosis department or infectious diseases department, with clinical symptoms (cough, expectoration for = 2 weeks) and abnormal imaging findings; B. No gender restriction, aged 18-80 years; C. Newly treated hospitalized patients; D. Having clear clinical diagnosis information, including basic information of clinical samples, medical records and other information. (2) Inclusion Criteria for Pediatric Pulmonary Tuberculosis Patient Samples A. Patients suspected of having tuberculosis in the tuberculosis department or infectious diseases department, with clinical symptoms (cough, expectoration for = 2 weeks) and abnormal imaging findings; B. No gender restriction, aged 0-14 years; C. Newly treated hospitalized patients; D. Having clear clinical diagnosis information, including basic information of clinical samples, medical records and other information. (3) Inclusion Criteria for Newly Treated Drug-Susceptible Pulmonary Tuberculosis Patients A. Based on the diagnosis of clinically active tuberculosis; patients diagnosed with active tuberculosis are determined as positive, with no gender restriction; B. Patients with positive GeneXpert (Mycobacterium tuberculosis molecular detection GeneXpert) and rifampicin susceptibility; C. Patients with positive initial sputum culture results and positive urine LAM detection results; D. Newly treated hospitalized patients with pulmonary tuberculosis; E. Having clear clinical diagnosis information, including basic information of clinical samples, medical records and other information.
Exclusion criteria
Exclusion criteria: 1. Positive Sample Exclusion Criteria A. Patients suspected of having tuberculosis without a clear diagnosis; B. Patients from whom a qualified urine sample cannot be collected. 2. Exclusion Criteria for Newly Treated Drug-Susceptible Pulmonary Tuberculosis Patients A. Patients suspected of having tuberculosis with a confirmed diagnosis (Note: This item may require confirmation of clinical logic; typically, "confirmed diagnosis" is an inclusion condition, and it is recommended to verify whether it is a wording error such as "unconfirmed diagnosis"); B. Newly treated tuberculosis patients with drug resistance; C. Patients from whom a qualified urine sample cannot be collected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactPang Yu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed