Verigene® Gram-Positive Blood Culture Nucleic Acid Test

Abstract

Bloodstream infections (BSIs) are a major cause of morbidity and mortality worldwide, and impose considerable costs on healthcare systems. A key predictor of clinical outcomes in patients with BSIs is the early initiation of appropriate targeted antimicrobial therapy. However, with conventional blood culture methods, the gold standard, there is a significant time delay of approximately 2-3 days before clinical results are available, with many patients receiving inappropriate and/or unnecessary antimicrobial therapy in the interim. During the past two decades, the use of in vitro assays that utilize nucleic acid amplification-based detection of pathogen-associated molecular patterns has led to a significant reduction in the time (hours vs. days with blood culture) to detection and identification of several of the causative pathogens of BSIs and, potentially, earlier initiation of targeted antimicrobial therapy. This review focuses on the properties and clinical use of one of these molecular diagnostic assays, the Verigene(®) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP), which detects many of the potentially pathogenic Gram-positive bacteria associated with BSIs, including Staphylococcus spp., Streptococcus spp., Listeria spp., and Enterococcus spp., and specific resistance markers (mecA, vanA, and vanB). Based on more than 1,600 samples, there was a high degree of agreement between BC-GP test results and those obtained using conventional blood culture and assay methods, irrespective of whether samples were fresh or frozen, and a high degree of agreement for identification of mecA-mediated meticillin resistance in S. aureus and S. epidermidis organisms and vanA- or vanB-mediated vancomycin resistance in E. faecalis and E. faecium organisms.