Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- specificity of TB-IGRA 2nd generation test
Study Overview
Brief Summary
Methodology This is a single-center study carried out as part of routine patient care.
The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.
Detailed Description
It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individual at least 18 years of age
- •Patient presenting for treatment of tuberculosis disease
- •Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
- •Informed patient who has not expressed opposition to participating in the study.
- •French-speaking patient with unambiguous understanding of oral and written instructions.
Exclusion Criteria
- •Persons in a period of exclusion from another study
- •Pregnant, parturient or breast-feeding women;
- •Person deprived of liberty by judicial or administrative decision
Arms & Interventions
TUBERCULOSIS (LATENTE OR ACTIVE) ARM
Intervention: test IGRA (Diagnostic Test)
TUBERCULOSIS (LATENTE OR ACTIVE) ARM
Intervention: TEST QUATIFERON TB Gold Plus (Diagnostic Test)
Outcomes
Primary Outcomes
specificity of TB-IGRA 2nd generation test
Time Frame: 24 MONTHS
sensitivity of TB-IGRA 2nd generation test
Time Frame: 24 MONTHS
Secondary Outcomes
No secondary outcomes reported