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

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

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

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