Accuracy and Feasibility of Xpert Ultra

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03072576

Enrollment

1400

Registered

2017-03-07

Start date

2016-03-31

Completion date

2017-10-31

Last updated

2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Pulmonary

Keywords

Diagnosis, Xpert MTB/RIF, Ultra Xpert MTB/RIF

Brief summary

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.

Interventions

DEVICEXpert 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

Belarus, Georgia, India, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026