Tuberculosis, Pulmonary
Conditions
Brief summary
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.
Interventions
DIAGNOSTIC_TESTCRISPR-based Test
CRISPR-based Test performed on sputum or BALF in TB suspects.
Sponsors
Wenzhou Central Hospital
Red Cross Hospital, Hangzhou, China
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Suspected pulmonary TB. * Ability and willingness of candidate or legal guardian/representative to provide informed consent. * Men and women age equal to or greater than 18 years.
Exclusion criteria
* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. | week 0 |
| Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. | week 0 |
| Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. | week 0 |
Countries
China
Contacts
Primary ContactWenhong Zhang
Backup ContactJingwen Ai
Outcome results
None listed