A multicenter study has demonstrated the effectiveness of the Staph ID/R blood culture panel from Great Basin Scientific Inc, Salt Lake City, for rapidly identifying several species of Staphylococci and accurately detecting the mecA gene directly from a positive blood culture.1
Results of the study, which was conducted across three clinical sites, demonstrated the performance and efficacy of the panel compared to conventional methods, and concluded that it provided decreased time to results at a lower price, helping physicians diagnose and deliver a timely, accurate, and cost-effective course of treatment.
Robert Jenison, Great Basin Scientific.
“Bloodstream infection-related sepsis, including those caused by methicillin-resistant Staphylococcus aureus (MRSA) and other pathogenic Staphylococcus species, is not only a leading cause of morbidity and mortality in the United States, but is also associated with over $17 billion in rising healthcare costs annually,” says Rob Jenison, chief technology officer and senior vice president of research and development at Great Basin Scientific. “Traditional blood culture methods provide physicians with a diagnosis 48 to 72 hours after a positive sample is identified, delaying appropriate treatment and putting the patient at further risk. Great Basin’s Staph ID/R blood culture panel is proven to provide highly accurate and actionable results in under 2 hours.”
Jenison continues, “Our panel potentially eliminates 32 to 88 hours of inappropriate antibiotic therapy, thereby potentially reducing length of patient stay and improving patient care, creating time and cost efficiencies for hospitals and labs of all sizes.”
Led by Gerald A. Denys, PhD, from the department of pathology and laboratory medicine at Indiana University, the study found that Great Basin’s panel correctly identified positive results for Staphylococcus species 99.4% of the time and negative results were correctly identified 99.9% of the time. Also, the mecA gene, a major drug resistance marker conferring resistance to methicillin and other beta-lactams and creating the superbug MRSA, was detected accurately from positive samples 99.7% of the time and negative results were properly identified 99.2% of the time.
Results of the study also revealed that the Great Basin molecular assay was more effective than conventional biochemical and cefoxitin disk methods performed at an independent laboratory, with performance estimates at 95% confidence intervals across all three sites. According to the company, its panel is one of the most comprehensive Staphylococcus molecular tests currently on the market, in that it identifies Staphylococcus aureus, Staphylococcus lugdunensis, and other Staphylococcus species to the genus level, and detects the mecA gene in all Staphylococcal species from positive blood cultures.
“We’re so pleased by the positive findings of this study and are excited by the response from the market for our blood culture panel,” says Sandra Nielsen, senior vice president of sales and marketing and human resources at Great Basin. “The results of this study illustrate our panel’s accuracy, cost-effectiveness, and ability to deliver definitive and highly actionable information, which we believe contribute to the increased adoption of our panel by a significant percentage of our installed customer base, as well as new and larger hospitals and labs.”
The company announced the commercial launch of the Staph ID/R blood culture panel in the United States and Europe in September 2016. The test has CE mark designation under the European Directive for In Vitro Diagnostic Medical Devices.
For more information, visit Great Basin Scientific.
Reference
- Denys GA, Collazo-Velez V, Young S, et al. Multicenter evaluation of the Portrait Staph ID/R blood culture panel for the rapid identification of Staphylococci and detection of mecA gene. J Clin Microbiol. Published online before print, 25 January 2017; doi: 1128/JCM.02348-16.
