Multicenter matched-pair study comparing BACT/ALERT® MP reagent systems for the recovery of mycobacteria from specimens other than blood.

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.
Competing Interests: 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.
(Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)