Great Basin Staph ID/R Blood Culture Panel
Multiplex detection of Staphylococcus Species and mec A resistance mechanism
The National Nosocomial Infection Surveillance System reports that sepsis is the leading cause of death in non-coronary ICUs, with the cost of care exceeding $17 billion in the US annually1.
Identification of bloodstream pathogens using traditional culture methods alone requires up to 3 days, with antimicrobial resistance mechanisms requiring additional testing after a bacterial isolate is obtained. Patients are often treated with broad, empiric antimicrobial therapy until a final ID and sensitivity is reported, contributing to increased antimicrobial resistance, hospital costs, and lengths of stay2. Inadequate or inappropriate treatment is currently seen in 20–25% of septic patients and is associated with a five-fold reduction in survival2.
Non-pathogenic blood culture contaminants from the patient’s skin or the environment frequently result in unnecessary hospital stays and antimicrobial therapy. Finally, as more payers are pushing back on extensive “one-size-fits-all” diagnostic panels, clinicians are looking for testing solutions that make sense based on gram stain results.
INTENDED USE
The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay, intended for the simultaneous identification of nucleic acid from Staphylococcus aureus, Staphylococcus lugdunensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens.
The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level.
The Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Sub-culturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.
This in vitro diagnostic test is configured for use on Great Basin Analyser with Great Basin Staph ID/R Blood Culture Panel Test Cartridge Kit.
FEATURES AND BENEFITS
Faster Clinical Decision Making and Improved Patient Outcomes
- Easy-to-use sample-to-result solution delivers more diagnostic data per sample than low-plex technologies
- Accurate results to direct appropriate antibiotic therapy
- Fast turnaround time (deliver results in <2 hrs)
- Patients with likely contaminants or methicillin susceptible pathogens can be de-escalated without waiting for the final culture ID and sensitivity
- High sensitivity and specificity
Increased Lab Productivity
- Blocks detection of contaminants present in the environment that may lead to false positive results
- Detects low-level Staphylococcus contamination
- Highly automated and easy-to-use
- Can be performed by all shifts
Increasing Laboratory Effectiveness
- Test for the relevant pathogens based on the gram stain results
- Sample-to-result with less than <2 mins hands-on-time per sample
- Efficiency benefits to hospitals and shorter stays for patients
- Small instrument footprint
WORKFLOW
SPECIFICATIONS
| Attribute | Value |
|---|---|
| Analytical Sensitivity |
S. aureus strains ± mecA: 3.5-8.2 x 105 CFU/mL S. epidermidis strains ± mecA: 2.2-7.1 x 105 CFU/mL S. lugdunensis strains without mecA: 2.8-4.7x105 CFU/mL Staphylococcus species ± mecA (excluding S. aureus, S. epidermidis, and S. lugdunensis): 1.5-5.3x105 CFU/mL |
| Analytical Reactivity |
Able to detect 100% of all Staphylococcus strains |
| Analytical Specificity |
No cross-reactivity with 116 off-panel microflora (bacterial, yeast, and mycoplasma strains) |
| Reproducibility | ≥98.7% |
| Sample Type(s) | Positive Blood Culture |
ORDERING INFORMATION
| Product | Pack Size | Item Number |
|---|---|---|
| Great Basin Toxigenic Staph ID/R Blood Culture Panel | 300785 |
References
1. National Surveillance Infections Surveillance (NNIS) System Report (Jan 1992-June 2004). Am. J. Infect. Control 2004; Oct; 32:470-485.
2. Klevens RM, Morrison, MA, Nadle J, et.al. “Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States.” JAMA 2007; Oct 17; 298(15):1763-1771.
3. Lebovitz EE, Burbelo PD. Commercial Multiplex Technologies for the Microbiological Diagnosis of Sepsis. Molecular diagnosis & therapy. 2013;17(4):221-231. doi:10.1007/s40291-013-0037-4.