TY - JOUR
T1 - Guidance for Studies Evaluating the Accuracy of Tuberculosis Triage Tests
AU - Nathavitharana, Ruvandhi R.
AU - Yoon, Christina
AU - Macpherson, Peter
AU - Dowdy, David W.
AU - Cattamanchi, Adithya
AU - Somoskovi, Akos
AU - Broger, Tobias
AU - Ottenhoff, Tom H.M.
AU - Arinaminpathy, Nimalan
AU - Lonnroth, Knut
AU - Reither, Klaus
AU - Cobelens, Frank
AU - Gilpin, Christopher
AU - Denkinger, Claudia M.
AU - Schumacher, Samuel G.
N1 - Funding Information:
Financial support. R. R. N. is funded by a National Institutes of Health Career Development Award (National Institute of Allergy and Infectious Diseases [NIAID] K23 AI13264801A1) and American Society of Tropical Medicine and Hygiene Burroughs Wellcome Fellowship. She acknowledges prior funding from a Harvard Center for AIDS Research Scholar Award (NIAID 2P30AI060354-11). C. Y. is funded by a National Institutes of Health Career Development Award (NIAID K23 AI114363). P. M. is funded by the Wellcome Trust (206575).
Funding Information:
by FIND (Foundation for Innovative New Diagnostics) and was made possible through the generous support of the Governments of the United Kingdom, the Netherlands, Germany and Australia.
Funding Information:
R. R. N. is funded by a National Institutes of Health Career Development Award (National Institute of Allergy and Infectious Diseases [NIAID] K23 AI13264801A1) and American Society of Tropical Medicine and Hygiene Burroughs Wellcome Fellowship. She acknowledges prior funding from a Harvard Center for AIDS Research Scholar Award (NIAID 2P30AI060354-11). C. Y. is funded by a National Institutes of Health Career Development Award (NIAID K23 AI114363). P. M. is funded by the Wellcome Trust (206575).
Publisher Copyright:
© 2019 The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.
PY - 2019/10/8
Y1 - 2019/10/8
N2 - Approximately 3.6 million cases of active tuberculosis (TB) go potentially undiagnosed annually, partly due to limited access to confirmatory diagnostic tests, such as molecular assays or mycobacterial culture, in community and primary healthcare settings. This article provides guidance for TB triage test evaluations. A TB triage test is designed for use in people with TB symptoms and/or significant risk factors for TB. Triage tests are simple and low-cost tests aiming to improve ease of access and implementation (compared with confirmatory tests) and decrease the proportion of patients requiring more expensive confirmatory testing. Evaluation of triage tests should occur in settings of intended use, such as community and primary healthcare centers. Important considerations for triage test evaluation include study design, population, sample type, test throughput, use of thresholds, reference standard (ideally culture), and specimen flow. The impact of a triage test will depend heavily on issues beyond accuracy, primarily centered on implementation.
AB - Approximately 3.6 million cases of active tuberculosis (TB) go potentially undiagnosed annually, partly due to limited access to confirmatory diagnostic tests, such as molecular assays or mycobacterial culture, in community and primary healthcare settings. This article provides guidance for TB triage test evaluations. A TB triage test is designed for use in people with TB symptoms and/or significant risk factors for TB. Triage tests are simple and low-cost tests aiming to improve ease of access and implementation (compared with confirmatory tests) and decrease the proportion of patients requiring more expensive confirmatory testing. Evaluation of triage tests should occur in settings of intended use, such as community and primary healthcare centers. Important considerations for triage test evaluation include study design, population, sample type, test throughput, use of thresholds, reference standard (ideally culture), and specimen flow. The impact of a triage test will depend heavily on issues beyond accuracy, primarily centered on implementation.
KW - diagnostics
KW - study design guidance
KW - target product profiles
KW - triage
KW - tuberculosis
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U2 - 10.1093/infdis/jiz243
DO - 10.1093/infdis/jiz243
M3 - Article
C2 - 31593600
AN - SCOPUS:85073052426
SN - 0022-1899
VL - 220
SP - S116-S125
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
ER -