Title

Clinical Performance of the Novel GenMark Dx ePlex® Blood Culture ID Gram-Positive Panel.

Document Type

Article

Publication Date

1-29-2020

Publication Title

Journal of clinical microbiology

Abstract

BACKGROUND: Rapid identification from positive blood cultures is standard of care (SOC) in many clinical microbiology laboratories. The GenMark Dx ePlex® Blood Culture ID Gram Positive (BCID-GP) Panel is a multiplex nucleic acid amplification assay based on competitive DNA hybridization and electrochemical detection using eSensor® technology. This multicenter study compared the Investigational Use Only (IUO) BCID-GP Panel to comparator methods for identification of 20 gram-positive bacteria, four antimicrobial resistance genes, and both Pan

MATERIALS AND METHODS: Ten microbiology laboratories throughout the USA collected residual, de-identified positive blood culture samples for analysis. Five laboratories tested both clinical and contrived samples with the BCID-GP Panel. Comparator identification methods included each laboratory's SOC, which included MALDI-TOF MS and automated identification systems, and targeted PCR/qPCR with bidirectional sequencing.

RESULTS: A total of 2,342 evaluable samples (1,777 clinical, 565 contrived) were tested with the BCID-GP Panel. The overall sample accuracy for on-panel organisms was 89% before discordant resolution. For pathogenic gram-positive targets (

CONCLUSION: The ePlex BCID-GP Panel compares favorably to SOC and targeted molecular methods for the identification of twenty gram-positive pathogens and four antimicrobial resistance genes in positive blood culture bottles. This panel detects a broad range of pathogens and mixed infections with yeast and gram-negative organisms from the same positive blood culture bottle.

PubMed ID

31996444

ePublication

ePub ahead of print

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