Feasibility and Accuracy of a Novel Xpert Cartridge

Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.

* For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator * For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using mycobacterial DNA sequencing as the reference comparator * Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as the reference comparator * Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test * For the investigational Xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error' * Proportion of study participants with M. tuberculosis detected in sputum * Proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)