Accuracy and Feasibility of Xpert Ultra

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Study of the Diagnostic Accuracy and Feasibility of the Xpert Ultra for Detection of TB and Rifampin Resistance in Adults Suspected of Having Pulmonary TB

Conditions
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Tuberculosis, Pulmonary

Intervention / Treatment
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* Device: Xpert MTB/RIF Ultra


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Xpert MTB/RIF Ultra|Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in sensitivity and specificity (ability to correctly identify those with TB and those without TB) between Xpert Ultra and Xpert MTB/ for Mycobacterium tuberculosis (MTB) detection (non-inferiority endpoint) |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Xpert Ultra for MTB detection (ability to correctly identify those with TB i.e. true positives), stratified by smear status |  | Day 1 | 
| Sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra for detection of Rifampin (RIF) resistance |  | Day 1 | 
| Difference in sensitivity and specificity (ability to correctly identify those with TB resistant to Rifampin and those with TB susceptible to Rifampin) of Xpert Ultra and Xpert MTB/RIF for detection of RIF resistance |  | Day 1 | 
| Proportion of test attempts that do not yield a determinate result for Xpert Ultra and for Xpert MTB/RIF |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Xpert MTB/RIF, Ultra Xpert MTB/RIF