Tuberculosis
Conditions
Brief summary
This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.
Interventions
PROCEDUREbronchoscopy
performance of bronchoscopy with BAL
Sponsors
Chinese University of Hong Kong
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients \> 18 years old suspected of TB clinically. 2. Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced. 3. BAL samples obtained following standard investigation procedure 4. CXR or CT imaging available.
Exclusion criteria
1. Bronchoscopy is not planned as a necessary procedure for investigation. 2. Diagnosis of active TB has been made by other means.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of true positive BAL PCR using GeneXpert on BAL for rapid diagnosis of TB in few hours compare to the conventional TB PCR which usually take up few days to perform | 1 year |
Countries
Hong Kong
Outcome results
None listed