Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2028-02-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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TUBERCULOSIS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TUBERCULOSIS (LATENTE OR ACTIVE) ARM

Group Type EXPERIMENTAL

test IGRA

Intervention Type DIAGNOSTIC_TEST

BLOOD SAMPLES

TEST QUATIFERON TB Gold Plus

Intervention Type DIAGNOSTIC_TEST

BLOOD SAMPLES

Interventions

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test IGRA

BLOOD SAMPLES

Intervention Type DIAGNOSTIC_TEST

TEST QUATIFERON TB Gold Plus

BLOOD SAMPLES

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No