Accuracy and Feasibility of Xpert Ultra

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Tuberculosis, Pulmonary

Treatments: Device: Xpert MTB/RIF Ultra

Study type: Observational

Funder types: Other

Identifiers

NCT03072576

7210-04-2/1

Details and patient eligibility

About

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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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