About Bloodstream Infections
Bloodstream infections occur when a pathogenic microorganism, usually a bacterium or a fungus, enters the bloodstream and causes an inflammatory immune response. Because bloodstream infections are pervasive problems associated with high mortality rates, timely delivery of appropriate treatment is essential. Studies have revealed that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour appropriate therapy is delayed.(2) The inability to rapidly identify resistant strains of pathogenic bacteria has led to antimicrobial use that is often ineffectual, wasteful, or bears risk of proliferating resistant strains.
According to the European Centre for Disease Control and Prevention (ECDC), 3.9% of patients staying more than 2 days in intensive care units throughout Europe acquire bloodstream infections, roughly 4.2 bloodstream infections per 1,000 patient days.(3) The ICU mortality in patients with ICU-acquired bloodstream infections is 33.2%, which is 2.4 times higher than for patients without bloodstream infections.(3) In addition, the length of stay in the ICU for patients that acquire bloodstream infections is approximately 3.5 times higher than for patients without bloodstream infections.(3)
Bloodstream infections with gram-negative bacteria are often complicated by antimicrobial resistance. Resistance rates are increasing among several problematic gram-negative pathogens that are often responsible for serious nosocomial infections including Acinetobacter, Pseudomonas aeruginosa, and Enterobacteriaceae. The presence of multi drug-resistant strains in these organisms has been associated with prolonged hospital stays, higher health care costs, and increased mortality.(4) New antimicrobial resistant mechanisms will continue to evolve leading to more multi drug-resistant gram-negative bacteria, which clinicians will have little to no antibiotic weapons for treatment.
About the CE IVD Mark
The CE IVD Mark is a requirement for in vitro diagnostic medical devices marketed in Europe. It is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation including those relating to safety. The CE IVD mark is recognized throughout the 27 EU member states as well as in Norway, Iceland and Liechtenstein. Products with the CE IVD Mark can be freely marketed anywhere in the EU without further control. In addition, it is generally seen as an important benchmark for product adoption in countries outside the EU.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene System, for multiplexed infectious disease, genetic, and ultra-sensitive protein testing. This easy-to-use platform offers laboratories a convenient, simple, and cost-effective solution for highly sensitive nucleic acid and protein testing. Nanosphere is based in Northbrook, IL.
For additional information regarding Nanosphere's infectious disease products, please contact Nanosphere at IDtesting@nanosphere.us or visit www.nanosphere.us.
1. 2012 CRE Toolkit - Guidance for Control of Carbapenem-resistant Enterobacteriaceae (CRE). Centers for Disease Control and Prevention. Retrieved from: http://www.cdc.gov/hai/organisms/cre/cre- toolkit/index.html.2. Kumar, A., Roberts, D., Wood, K.E. (2006). Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 34(6): 1589-1596.3. "Surveillance of Healthcare-Associated Infections in Europe." European Centre for Disease Control and Prevention. Retrieved from: http://www.ecdc.europa.eu/en/publications/Publications/120215_SUR_HA I_2007.pdf.4. Slama, T.G. (2008) Gram-negative antibiotic resistance: there is a price to pay. Critical Care 12(Suppl 4):S4.
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