Framework for the evaluation of new tests for tuberculosis infection.

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.

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Copyright ©The authors 2021.

Déclaration de conflit d'intérêts

Conflict of interest: Y. Hamada has nothing to disclose. Conflict of interest: S. den Boon has nothing to disclose. Conflict of interest: D.M. Cirillo has nothing to disclose. Conflict of interest: A. Penn-Nicholson: FIND has several clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review. FIND has not allocated any financial value to know-how or access to equipment gained through these projects. Current projects are listed at www.finddx.org for more information. In addition, A. Penn-Nicholson has a patent WO2016123058A1 WIPO (PCT) (Biomarkers for detection of tuberculosis risk 2016-08-04) pending, and a patent WO2017081618A9 WIPO (PCT) (Biomarkers for prospective determination of risk for development of active tuberculosis 2017-07-13) pending. Conflict of interest: M. Ruhwald: FIND has several clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review. FIND has not allocated any financial value to know-how or access to equipment gained through these projects. Current projects are listed at www.finddx.org for more information. In addition, M. Ruhwald has a patent WO2017084671A1 issued to Statens Serum Institute, and a patent O2008028489A2 issued to Statens Serum Institute. Conflict of interest: D. Menzies has nothing to disclose. Conflict of interest: O. Oxlade has nothing to disclose. Conflict of interest: D. Falzon has nothing to disclose. Conflict of interest: A. Kanchar has nothing to disclose. Conflict of interest: A. Korobitsyn has nothing to disclose. Conflict of interest: M. Zignol has nothing to disclose. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: T. Kasaeva has nothing to disclose.