AdvanDx Inc, Woburn, Mass, introduces Gram-Negative QuickFISH BC, a new rapid molecular diagnostic test that identifies potentially life threatening bloodstream infections caused by Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae within 20 minutes of a positive blood culture.
It further expands the QuickFISH Platform, which can now identify the pathogens responsible for 90% of positive blood cultures.1
The new platform enables 20-minute species identification of bacteria directly from positive blood cultures, allowing the reporting of pathogen identification at the same time as the reporting of Gram stain results.
Five minute hands-on time simplifies and streamlines lab workflow. Built-in, universal controls ensure confidence in test results.
The test provides clinicians with information that can help them prescribe earlier, targeted therapy for gram-negative pathogens and potentially improve mortality rates and patient survival,2 and when combined with antibiotic stewardship programs, it can provide accurate and timely therapy to assist hospitals in meeting the goals of organizations like the New York Department of Health, the State of California, and the IDSA.
Gram-negative bloodstream infections, especially those caused by Pseudomonas aeruginosa, are associated with high mortality rates and can be difficult to treat due to increasing resistance to antimicrobial agents. Traditional lab testing methods take 24 to 48 hours or longer to identify the causative pathogen, forcing clinicians to treat patients based on limited information. This presents a challenge for the health care provider as the decision to add an anti-pseudomonal drug should ideally be based primarily on knowledge of the infecting species. As a result, patients with gram-negative bloodstream infections are often either subjected to broader than necessary antimicrobial therapies, which may be toxic and may promote the development of drug resistance, or they may be undertreated, increasing their risk for adverse outcomes.
AdvanDx expects to introduce the fourth QuickFISH assay for identification of Candida species from positive blood cultures in the second half of 2013, following regulatory clearance.
1 Ann Clin Microbiol Antimicrob. 2004 May 10;3:7.
2 Crit. Care Med. 2006, 34:1589-1596.