RT Journal Article
SR Electronic
T1 Framework for the evaluation of new tests for tuberculosis infection
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 2004078
DO 10.1183/13993003.04078-2020
A1 Yohhei Hamada
A1 Saskia den Boon
A1 Daniela Maria Cirillo
A1 Adam Penn-Nicholson
A1 Morten Ruhwald
A1 Dick Menzies
A1 Olivia Oxlade
A1 Dennis Falzon
A1 Avinash Kanchar
A1 Alexei Korobitsyn
A1 Matteo Zignol
A1 Alberto Matteelli
A1 Tereza Kasaeva
YR 2021
UL http://erj.ersjournals.com/content/early/2021/01/14/13993003.04078-2020.abstract
AB 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.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Hamada has nothing to disclose.Conflict of interest: Dr. Den Boon has nothing to disclose.Conflict of interest: Dr. Cirillo has nothing to disclose.Conflict of interest: Dr. Penn-Nicholson reports grants and non-financial support from multiple partners, during the conduct of the study; In addition, Dr. 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: Dr. Ruhwald reports grants and non-financial support from multiple, during the conduct of the study; In addition, Dr. Ruhwald has a patent WO2017084671A1 issued to Statens Serum Institute, and a patent O2008028489A2 issued to Statens Serum Institute.Conflict of interest: Dr. menzies has nothing to disclose.Conflict of interest: Dr. Oxlade has nothing to disclose.Conflict of interest: Dr. Falzon has nothing to disclose.Conflict of interest: Dr. Kanchar has nothing to disclose.Conflict of interest: Dr. Korobitsyn has nothing to disclose.Conflict of interest: Dr. Zignol has nothing to disclose.Conflict of interest: Dr. Matteelli has nothing to disclose.Conflict of interest: Dr. Kasaeva has nothing to disclose.