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.
Study Type
OBSERVATIONAL
Enrollment
800
CRISPR-based Test performed on sputum or BALF in TB suspects.
Huashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProportion 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.
Time frame: 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.
Time frame: week 0
Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF.
Time frame: week 0
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