TUBERCULOSIS
Conditions
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
Interventions
DIAGNOSTIC_TESTtest IGRA
BLOOD SAMPLES
DIAGNOSTIC_TESTTEST QUATIFERON TB Gold Plus
BLOOD SAMPLES
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity of TB-IGRA 2nd generation test | 24 MONTHS |
| specificity of TB-IGRA 2nd generation test | 24 MONTHS |
Countries
France
Contacts
Primary ContactPR PIERRE EDOUARD FOURNIER PU-PH
Backup ContactALEXANDRA GIULIANI PROJECT MANAGER
Outcome results
None listed