Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan
University College London, London, UK.
Eur Respir J. 2021 Aug 19;58(2). doi: 10.1183/13993003.04078-2020. Print 2021 Aug.
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.
加快结核病（TB）预防性治疗（TPT）的推广，以实现联合国结核病问题高级别会议和终结结核病战略所设定的目标。实施现有结核病感染检测方法存在操作方面的挑战，这阻碍了有效的 TPT 的推广。新的更简单的检测方法可以促进结核病感染检测的推广。我们提出了一个评估新的结核病感染免疫诊断检测的框架，旨在促进其标准化评估，并加速其纳入全球和国家政策以及随后的推广。该框架描述了评估结核病感染新检测方法时需要考虑的原则，并为制造商、研究人员、监管机构和其他用户提供关于研究设计、人群、参考标准、样本量计算以及数据分析的指导，该框架也与 2020 年世界卫生大会通过的《全球结核病研究与创新战略》保持一致。此外，我们还简要描述了评估新检测方法时应考虑的技术问题，包括皮试的安全性、患者和卫生系统的成本以及操作特点。
