Multicenter matched-pair study comparing BACT/ALERT® MP reagent systems for the recovery of mycobacteria from specimens other than blood.
Culture
Detection
Mycobacteria
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:
Oct 2023
Oct 2023
Historique:
received:
14
06
2022
revised:
29
03
2023
accepted:
16
04
2023
medline:
28
8
2023
pubmed:
4
8
2023
entrez:
3
8
2023
Statut:
ppublish
Résumé
The BACT/ALERT® MP Reagent System is a broth culture medium for optimal detection and recovery of mycobacteria from clinical samples. The MP formulation was recently modified to improve detection and recovery times. A multicenter prospective matched pair study design was conducted to validate the performance of improved MP (MP-I) versus current MP (MP-C) bottles utilizing nonsterile and normally sterile samples, except blood, from patients suspected of having mycobacterial infections. A total of 1488 clinical samples were collected to obtain 212 mycobacteria samples by either or both MP culture bottles. MP-I and MP-C sensitivities were 86.6% and 81.4%, respectively, but the difference was not significant (P = 0.163) while specificities were 96.8% and 93.8%, respectively, and that difference was significant (P = 0.002). Overall recovery was 94.34% for MP-I and 88.68% for MP-C (recovery was 100% for both bottles with 52 seeded samples). Overall performance of MP-I was better than MP-C for sensitivity, specificity, and recovery.
Identifiants
pubmed: 37536260
pii: S0732-8893(23)00069-X
doi: 10.1016/j.diagmicrobio.2023.115959
pii:
doi:
Substances chimiques
Culture Media
0
Reagent Kits, Diagnostic
0
Types de publication
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115959Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest HPD, KM, JK, CDG, and DHP are employees of bioMérieux, Inc. SG was an employee of bioMérieux, Inc and has since relocated to another institution. As this was a Clinical Trial, bioMérieux employees were involved in study design and data analysis. Study sites were responsible for testing and data collection. This study was funded by bioMérieux, Inc. BACT/ALERT® MP Reagent Systems are FDA 510(k) cleared.