Feasibility and Accuracy of a Novel Xpert Cartridge
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)
Inclusion Criteria:

 -  Individuals must meet all of the following inclusion criteria in order to be eligible
 to participate:

 -  Age ≥ 19 years (age of majority) if enrolled in South Korea; age ≥ 18 years (age
 of majority) if enrolled in China

 -  Provision of informed consent

 -  Clinical signs and/or symptoms suggestive of pulmonary tuberculosis

 -  Meets one of the following criteria:

 A. Suspected or confirmed new pulmonary tuberculosis case who has received
 anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is
 approximately 50 participants).

 B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received
 anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing
 signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance

 Exclusion Criteria:

 -  Inability to provide a sputum specimen