eprintid: 10120522 rev_number: 26 eprint_status: archive userid: 608 dir: disk0/10/12/05/22 datestamp: 2021-02-02 17:13:24 lastmod: 2022-04-05 18:17:01 status_changed: 2021-02-02 17:13:24 type: article metadata_visibility: show creators_name: Hamada, Y creators_name: Den Boon, S creators_name: Maria Cirillo, D creators_name: Penn-Nicholson, A creators_name: Ruhwald, M creators_name: Menzies, D creators_name: Oxlade, O creators_name: Falzon, D creators_name: Kanchar, A creators_name: Korobitsyn, A creators_name: Zignol, M creators_name: Matteelli, A creators_name: Kasaeva, T title: Framework for the evaluation of new tests for tuberculosis infection ispublished: pub divisions: UCL divisions: B02 divisions: D01 divisions: G16 note: Copyright © The authors 2021. This version is distributed under the terms of the Creative Commons Attribution Licence 4.0. 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. We also 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 patient, and operational characteristics. date: 2021-08 date_type: published official_url: https://doi.org/10.1183/13993003.04078-2020 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1844429 doi: 10.1183/13993003.04078-2020 pii: 13993003.04078-2020 lyricists_name: Hamada, Yohhei lyricists_id: YHAMA00 actors_name: Flynn, Bernadette actors_id: BFFLY94 actors_role: owner full_text_status: public publication: European Respiratory Journal volume: 58 number: 2 article_number: 2004078 event_location: England citation: Hamada, Y; Den Boon, S; Maria Cirillo, D; Penn-Nicholson, A; Ruhwald, M; Menzies, D; Oxlade, O; ... Kasaeva, T; + view all <#> Hamada, Y; Den Boon, S; Maria Cirillo, D; Penn-Nicholson, A; Ruhwald, M; Menzies, D; Oxlade, O; Falzon, D; Kanchar, A; Korobitsyn, A; Zignol, M; Matteelli, A; Kasaeva, T; - view fewer <#> (2021) Framework for the evaluation of new tests for tuberculosis infection. European Respiratory Journal , 58 (2) , Article 2004078. 10.1183/13993003.04078-2020 <https://doi.org/10.1183/13993003.04078-2020>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10120522/8/Hamada_2004078.full.pdf