Completed Infection & Immunity Lungs & Breathing

IGRA in Diagnostic Evaluation of Active TB (IDEA)

Funder NIHR (part of DHSC)
Recipient organisation Imperial College London
Funding £1.6M
Period Mar 2011 — Dec 2015

In plain English

AI plain-English summary

Doctors in the NHS are putting two blood tests head-to-head to find out which one best catches active tuberculosis (TB) before it spreads. TB remains a stubborn public health problem in the UK, particularly in cities and among people with weakened immune systems, such as those with HIV. Current diagnostic methods—sputum samples and chest X-rays—can be slow, miss cases, or fail to distinguish active disease from past infection. The two tests in question, ELISpot and ELISA, both detect immune responses to TB bacteria, but it is unclear how well they perform in routine NHS clinics for people with suspected active TB. If this study succeeds, it will produce a clear, cost-effective testing algorithm that the NHS can adopt immediately. That could mean faster diagnosis, fewer missed cases, and less unnecessary treatment. The health economic analysis will tell the NHS whether the extra cost of these tests is justified by better outcomes. The results are expected to shape TB control policies not only in the UK but also in Europe and North America, where similar diagnostic dilemmas exist.

View original technical description
The aim of this study is to compare the accuracy of diagnostic strategies, including a comparison between existing interferon-gamma release assays (IGRAs) and conventional diagnostic testing. The role of IGRAs for participants (including HIV co-infected patients) who have been diagnosed as having suspected active tuberculosis (ATB) will also be defined. The study will determine sensitivity, specificity, positive and negative predictive values and likelihood ratios of the ELISpot-based IGRA and the ELISA-based IGRA for diagnosis of active tuberculosis, in routine clinical practice. The study will be measured against a validated pre-defined composite reference standard for active tuberculosis. Next-generation IGRAs will be evaluated in parallel. The accuracy of these different testing strategies will be compared and an optimal testing algorithm defining the precise role of these technologies in the diagnostic work-up of suspected active tuberculosis in the NHS (National Health Service) will be developed. Health economic analysis, from an NHS perspective, will determine the cost-effectiveness of each testing strategy, following NICE (National Institute for Health & Clinical Excellence) guidelines. The results of this study will influence tuberculosis control and elimination policy here in the UK, in Europe and North America.

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