IFIAS-10 TB IGRA Evaluation
Research type
Research Study
Full title
Verification of the IFIAS-10 TB IGRA assay for routine diagnosis of TB exposure in adult patients.
IRAS ID
332657
Contact name
Kelly L Bicknell
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Tuberculosis (TB) is an infection that is a huge global burden. TB infection usually affects the lungs. It can cause an infection straight away, but some people have TB in their body but do not get ill or have any symptoms (latent TB). Latent TB can become active in later life or when immunity wanes. It can be treated with antibiotics but can be serious if not treated. Many people do not know they have latent TB, therefore it is important to test for it.
Current tests to detect latent TB infection often take significant time or are logistically challenging to arrange or require very specialist review which is costly. There is therefore a need for a diagnostic method that is simpler to arrange, easy to use, sensitive, rapid and inexpensive.
This study will evaluate the use of a TB IGRA assay, which can be performed in local NHS labs, to diagnose latent TB infections from a participant’s blood sample. Evaluation of a new assay to make sure it works as stated by the manufacturer, is a requirement before it can be used for routine diagnosis of infection.
REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0354
Date of REC Opinion
4 Jan 2024
REC opinion
Further Information Favourable Opinion