Tests for tuberculosis infection: landscape analysis.
Journal
The European respiratory journal
ISSN: 1399-3003
Titre abrégé: Eur Respir J
Pays: England
ID NLM: 8803460
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
18
01
2021
accepted:
05
04
2021
pubmed:
21
4
2021
medline:
15
12
2021
entrez:
20
4
2021
Statut:
epublish
Résumé
Only the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs), QuantiFERON-TB Gold In-Tube and T-SPOT.TB, are currently endorsed by the World Health Organization as tests for tuberculosis (TB) infection. While IGRAs are more specific than the TST, they require sophisticated laboratory infrastructure and are costly to perform. However, both types of tests have limited performance to predict development of active TB. Tests with improved predictive performance and operational characteristics are needed. We reviewed the current landscape of tests for TB infection identified through a web-based survey targeting diagnostic manufacturers globally. We identified 20 tests for TB infection: 15 New tests have the potential to improve accuracy, operational characteristics and end-user access to tests for TB infection. However, published data in various populations and settings are limited for most new tests. Evaluation of these new tests in a standardised design would facilitate their endorsement and programmatic scale-up.
Sections du résumé
BACKGROUND
Only the tuberculin skin test (TST) and two interferon-γ release assays (IGRAs), QuantiFERON-TB Gold In-Tube and T-SPOT.TB, are currently endorsed by the World Health Organization as tests for tuberculosis (TB) infection. While IGRAs are more specific than the TST, they require sophisticated laboratory infrastructure and are costly to perform. However, both types of tests have limited performance to predict development of active TB. Tests with improved predictive performance and operational characteristics are needed.
METHODS
We reviewed the current landscape of tests for TB infection identified through a web-based survey targeting diagnostic manufacturers globally.
RESULTS
We identified 20 tests for TB infection: 15
CONCLUSIONS
New tests have the potential to improve accuracy, operational characteristics and end-user access to tests for TB infection. However, published data in various populations and settings are limited for most new tests. Evaluation of these new tests in a standardised design would facilitate their endorsement and programmatic scale-up.
Identifiants
pubmed: 33875495
pii: 13993003.00167-2021
doi: 10.1183/13993003.00167-2021
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright ©The authors 2021. For reproduction rights and permissions contact permissions@ersnet.org.
Déclaration de conflit d'intérêts
Conflict of interest: Y. Hamada has nothing to disclose. Conflict of interest: D.M. Cirillo reports grants from bioMérieux. Conflict of interest: A. Matteelli has nothing to disclose. Conflict of interest: A. Penn-Nicholson reports grants and nonfinancial support from multiple partners, outside the submitted work: FIND has several clinical research projects to evaluate multiple new diagnostic tests against published target product profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know-how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review. FIND has not allocated any financial value to know-how or access to equipment gained through these projects. In addition, A. Penn-Nicholson is an inventor on a patent for prediction of tuberculosis disease risk (WO2017081618A9); rights have been assigned to the University of Cape Town and Seattle Biomed. Conflict of interest: M.X. Rangaka has nothing to disclose. Conflict of interest: M. Ruhwald is an inventor on patents disclosing the use of specific skin tests and IP-10 for the diagnosis of tuberculosis infection (WO2017084671, WO2008028489, WO2012076020 and WO2011137902); all rights have been assigned to Copenhagen University Hospitals and Statens Serum Institut.