Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: test IGRA, TEST QUATIFERON TB Gold Plus.
- Who it may be relevant to
- Registry conditions: TUBERCULOSIS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Diagnostic test test IGRA
BLOOD SAMPLES - Diagnostic test TEST QUATIFERON TB Gold Plus
BLOOD SAMPLES
Primary outcome measures
- sensitivity of TB-IGRA 2nd generation test [Time frame: 24 MONTHS]
- specificity of TB-IGRA 2nd generation test [Time frame: 24 MONTHS]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Assistance Publique Hopitaux de Marseille — Marseille
Identifiers
NCT: NCT06485895 · RCAPHM24_0100 · 2024-A00322-45