MRSA/SA ELITe MGB® – IVD

Market Segment: , ,

Enabling healthcare providers to make better medical decisions, improve patient outcomes and deliver a superior level of service and care.

MRSA/SA ELITe MGB® is a qualitative Real-Time PCR test for the direct detection of S. aureus and MRSA DNA purified from human nasal swab specimens.

FDA CLEARED

Catalogue Number(s)

M800346
Product Description: MRSA/SA ELITe MGB® (Each kit contains: PCR Monoreagent, Internal Control and Positive Control)
Number of tests per Kit: 100 Tests

Clinical Significance of Hospital Acquired Infections

The probability of acquiring an infection in a healthcare setting is relatively high, and the risk of death is not negligible. Data from the Centers for Disease Control and Prevention (CDC) indicate that over 1 million healthcare associated infections (HAIs) occur in the US every year, causing around 100,000 deaths, nearly one-fifth of those caused by MRSA.  According to a study published by the “Global Patient Safety Challenge: Clean Care Is Safer Care” more than 1.4 million people worldwide suffer from an HAI at any given time.

S. aureus and Methicillin-Resistant S. aureus (MRSA) are formidable and growing subsets of HAIs.  The incidence rate for S. aureus in the general population is approximately 30%.  Incidence rates for MRSA in the general population range from 2 – 4%, many of whom are asymptomatic.  In the US, incidence rates of 5 – 10% have been observed for inpatient populations (based on hospital admissions) creating a significant public health issue.

S. aureus and MRSA create serious economic challenges for healthcare providers due to the impact they have on patient safety, quality of care and overall healthcare costs.  These significant, incremental costs, typically are not reimbursed by third party payers (categorized as “Never Events”) and have fuelled the debate over the merits of MRSA screening and surveillance strategies.


Intended Use

MRSA/SA ELITe MGB® Kit is a qualitative Real-Time PCR test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from human nasal swabs specimen.


Indication for Use

MRSA/SA ELITe MGB® Kit is intended to aid in the prevention and control of MRSA infections in healthcare settings.  It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

“Better detection, effective control and prevention, improved outcomes, significantly lower overall cost.”

Cost-effective:  The MRSA/SA ELITe MGB® test has one of the lowest MRSA false negative results among Real-Time PCR tests in the industry dramatically improving patient outcomes.  This significantly reduces incremental overall costs to deliver appropriate and timely care and may result in institutional savings measured in hundreds of thousands of dollars.

Cost-competitive:  ELITechGroup’s MRSA/SA ELITe MGB® per test cost is very advantageous when compared to competitors’ prices.

Optimized design: Uses our patented MGB technologies for improved discrimination, enhanced result integrity and increased specificity.

Flexible: The open-platform design will allow laboratories to easily adapt the assay to their current workflow.  This unique feature enables laboratories to run our entire ASR menu for transplant and respiratory pathogen testing.