Abstract
The scale-up of tuberculosis (TB) preventive treatment (TPT) must be accelerated to achieve the targets set by the United Nations High-level Meeting on TB and the End TB Strategy. The scale-up of effective TPT is hampered by concerns about operational challenges to implement the existing tests for TB infection. New simpler tests could facilitate the scale-up of testing for TB infection. We present a framework for evaluation of new immunodiagnostic tests for the detection of TB infection, with an aim to facilitate their standardised evaluation and accelerate adoption into global and national policies and subsequent scale-up. The framework describes the principles to be considered when evaluating new tests for TB infection and provides guidance to manufacturers, researchers, regulators and other users on study designs, populations, reference standards, sample size calculation and data analysis and it is also aligned with the Global Strategy for TB Research and Innovation adopted by the World Health Assembly in 2020. In addition, we briefly describe technical issues that should be considered when evaluating new tests, including the safety for skin tests, costs incurred by patients and the health system, and operational characteristics.
Highlights
Treatment of tuberculosis (TB) infection, known as tuberculosis preventive treatment (TPT), is a critical component needed to achieve the ambitious targets of the End TB Strategy 2016–2035 [1]
The tests are helpful to identify people at higher risk of developing TB disease and who could benefit from TPT, because in most published studies such risk is higher in people who test positive for TB infection than in those who test negative [7]
We briefly outline technical issues that should be considered when evaluating new tests for TB infection, evaluation of safety for skin tests, costs incurred by patients and the health system and operational characteristics
Summary
Treatment of tuberculosis (TB) infection, known as tuberculosis preventive treatment (TPT), is a critical component needed to achieve the ambitious targets of the End TB Strategy 2016–2035 [1]. Without the prospect that a new, efficacious and safe TB vaccine can be developed and scaled-up worldwide in the foreseeable future, continued measures to expand the provision of effective TPT remain of critical importance. Progress in expanding TPT coverage among contacts of TB patients has been very limited up to now, with approximately half a million contacts in 2019 [4]. The tests are helpful to identify people at higher risk of developing TB disease and who could benefit from TPT, because in most published studies such risk is higher in people who test positive for TB infection than in those who test negative [7]. Current tests for TB infection have limited value in predicting the risk of progression from infection to active TB disease [8]
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