VIDAS3® TB-IGRA assay: evaluation of performance characteristics in a predominantly low risk, low incidence population.
Comparison
Evaluation
Reproducibility
TB-IGRA
Tuberculosis
VIDAS3®
Journal
Diagnostic microbiology and infectious disease
ISSN: 1879-0070
Titre abrégé: Diagn Microbiol Infect Dis
Pays: United States
ID NLM: 8305899
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
06
10
2022
revised:
13
12
2022
accepted:
27
12
2022
pubmed:
2
2
2023
medline:
22
3
2023
entrez:
1
2
2023
Statut:
ppublish
Résumé
To evaluate the analytical performance of the TB-IGRA® assay on the VIDAS3 platform (bioMérieux) when testing a predominantly low risk population in a low incidence area. Eighty-eight percent of the results were concordant between QuantiFERON®-TB Gold-Plus (QFT®-Plus, QIAGEN) and TB-IGRA®. All 12 of 99 (12.1%) discordant results were determined positive only with the TB-IGRA® assay. In 11 of 12 of these discordant cases, no explanation could be found in the medical record. Five of these discrepant results were probably caused by the use of contaminated stimulation reagents. The remaining 6 discrepant samples were also part of the reproducibility experiment and only 2 results were reproducible positive. Overall, in the reproducibility experiment 5 of 25 (20.0 %) results were not repeatable. the TB-IGRA® assay seems prone to contamination. Besides, we documented a reproducibility of only 80.0% with the TB-IGRA® assay.
Identifiants
pubmed: 36724698
pii: S0732-8893(22)00249-8
doi: 10.1016/j.diagmicrobio.2022.115885
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115885Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.