Guidance for Studies Evaluating the Accuracy of Tuberculosis Triage Tests.
Adult
Biological Assay
/ economics
Biomarkers
/ blood
Blood Culture
/ standards
Child
Cohort Studies
Cross-Sectional Studies
Diagnostic Tests, Routine
/ economics
Humans
Mycobacterium tuberculosis
/ isolation & purification
Practice Guidelines as Topic
Reference Standards
Research Design
Risk Factors
Sensitivity and Specificity
Sputum
/ microbiology
Triage
/ economics
Tuberculosis, Pulmonary
/ diagnosis
World Health Organization
diagnostics
study design guidance
target product profiles
triage
tuberculosis
Journal
The Journal of infectious diseases
ISSN: 1537-6613
Titre abrégé: J Infect Dis
Pays: United States
ID NLM: 0413675
Informations de publication
Date de publication:
08 10 2019
08 10 2019
Historique:
entrez:
9
10
2019
pubmed:
9
10
2019
medline:
20
5
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 31593600
pii: 5583863
doi: 10.1093/infdis/jiz243
pmc: PMC6782021
doi:
Substances chimiques
Biomarkers
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
S116-S125Subventions
Organisme : Wellcome Trust
ID : 206575
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : P30 AI060354
Pays : United States
Organisme : Wellcome Trust
ID : 206575/Z/17/Z
Pays : United Kingdom
Organisme : NIAID NIH HHS
ID : K23 AI114363
Pays : United States
Organisme : NIAID NIH HHS
ID : K23 AI132648
Pays : United States
Organisme : World Health Organization
ID : 001
Pays : International
Organisme : Medical Research Council
ID : MR/R015600/1
Pays : United Kingdom
Informations de copyright
© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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