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

Assistance Publique Hopitaux De Marseille500 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

500

Conditions

TUBERCULOSIS

Interventions

test IGRADIAGNOSTIC_TEST

BLOOD SAMPLES

TEST QUATIFERON TB Gold PlusDIAGNOSTIC_TEST

BLOOD SAMPLES

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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