TB-IGRA Performance Evaluation Study - CTPR01
Research type
Research Study
Full title
Performance evaluation of the VIDAS® TB-IGRA assay (Active TB Study)
IRAS ID
265866
Contact name
Stephanie Pascual
Contact email
Sponsor organisation
bioMerieux SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
Tuberculosis (TB) is caused by the bacterium Mycobacterium tuberculosis (Mtb) that is spread from person to person through the air. TB usually affects the lungs (pulmonary TB), but it can also affect other parts of the body such as the brain, kidneys, spine or lymph nodes (extra-pulmonary TB). Two TB-related conditions exist: latent TB infection (LTBI) and TB disease.
People with LTBI are not ill, do not present TB symptoms or have TB disease; they are not contagious and cannot spread TB infection to others. The only sign of TB infection is a positive reaction to the tuberculin skin test (TST) or TB blood tests such as Interferon-Gamma Release Assays (IGRAs). Without treatment, infected persons risk developing TB disease.
Identification and treatment of LTBI can substantially reduce the risk of developing active disease and spreading TB infection to others. Although both the TST and TB-IGRAs are acceptable, TB-IGRAs are the preferred test being adopted in clinical practice and guidelines.
The study objective is to evaluate the sensitivity of the VIDAS® TB-IGRA assay compared to that of the commercially available QuantiFERON®-TB Gold (QFT) Plus assay on approximately 400 culture-confirmed active TB patients ≥ 2 years of age and satisfying specified inclusion criteria. The study is being conducted worldwide to allow the commercialization of the VIDAS® TB-IGRA qualitative assay, intended to aid the diagnosis of latent or active Mtb infection. In the UK, the study will take place in hospital-based sites. It is anticipated that patients will have one visit for the collection of a primary sample (e.g. sputum) for mycobacterium species identification, and blood samples for the TB-IGRA assays and HIV testing (if applicable). Sample collection will form part of the patients' clinical routine whenever possible.
The trial is anticipated to last no longer than 5 months.
REC name
Wales REC 7
REC reference
19/WA/0284
Date of REC Opinion
15 Oct 2019
REC opinion
Further Information Favourable Opinion