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