Accuracy and Feasibility of Xpert Ultra
Accuracy and Feasibility of Xpert Ultra
Consenting adults presenting with signs and symptoms compatible with pulmonary tuberculosis
 will be interviewed for demographic and medical information, and then will be asked to
 provide 3-4 expectorated sputum specimens. In the study laboratory, sputa will be tested
 using conventional and investigational diagnostic tests for tuberculosis and rifampin
 resistance.
Case Detection Group

 Inclusion Criteria:

 -  Age 18 years or above;

 -  Provision of informed consent;

 -  Willingness to provide 4 sputum specimens at enrolment;

 -  Willingness to have a study follow-up visit approximately 42 to 70 days after
 enrolment

 -  Clinical suspicion of pulmonary TB (including cough ≥2 weeks and at least 1 other
 symptom typical of TB)

 Exclusion Criteria:

 -  Receipt of any dose of TB treatment within 6 months prior to enrolment

 -  Participants for whom, at the time of enrolment, the follow-up visit is judged to be
 poorly feasible (e.g. individuals planning to relocate)

 Drug-Resistant TB Group

 Inclusion Criteria:

 -  Age 18 years or above;

 -  Provision of informed consent;

 -  Willingness to provide 4 sputum specimens at enrolment;

 -  Non-converting pulmonary TB cases (category I and category II failures) or multi-drug
 resistant (MDR) suspect* (based on World Health Organization definition), i.e. at
 least one of the following: i) retreatment cases, ii) active TB cases that are
 MDR-contacts and iii) patients at high risk for MDR-TB as determined by local program
 (e.g. prisoners)

 Exclusion Criteria:

 • none