For in vitro diagnostic use. RIDA®GENE MRSA LC2.0 is a multiplex real-time PCR for the direct, qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (MSSA) or methicillin-resistant coagulase-negative Staphylococci from human nasal swabs and cultures on the LightCycler® 2.0.
RIDA®GENE MRSA LC2.0 real-time multiplex PCR is intended for use as an aid in diagnosis of MRSA infection.
Staphylococci commonly colonise the skin and mucous membranes of humans and other mammals. They are classified into coagulase-positive (S. aureus) and coagulase-negative staphylococci (e.g. S. epidermidis).
Staphylococcus aureus is a major cause of nosocomial infections in hospitals and healthcare settings. Transmission occurs through health care providers or other patients. It is estimated that 30% of the healthy population are colonised (asymptomatic carriers) with S. aureus. Methicillin-resistant Staphylococcus aureus (MRSA) is the leading cause of nosocomial infections worldwide (hospital-acquired MRSA also called HA-MRSA). Beside HA-MRSA infections also community-aquired MRSA infections (CA-MRSA) occur, which are acquired outside the hospital. In the recent years also MRSA infections associated with livestock (livestock-associated MRSA or LA-MRSA) emerged, especially with pig farmers.
MRSA are methicillin (oxacillin) resistant by virtue of the chromosomal mecA gene that encodes the penicillin binding protein (PBP2a). The mecA gene is located on a mobile genetic element called SCCmec gene cassette (Staphylococcal cassette chromosome mec). Today, eleven SCCmec types are described, of which types I to V are the most common.
The SCCmec element type XI, which contains a new mecA homologue (mecC or mecLGA251) was initially described in 2011. The mecC gene exhibits only a 70% nucleotide homology with mecA and is not detectable by usual mecA-specific PCRs and PBP2a agglutinations tests. This has been described in S. aureus isolates from humans and cattle.
In contrast to infections with MSSA (Methicillin-sensitive Staphylococcus aureus), MRSA infections are associated with a higher morbidity, mortality, long lasting hospitalization and higher health care costs. Risk factors for MRSA infection within healtcare settings include prolonged hospital stay, history of MRSA infection or colonisation, proximity to patients infected with MRSA and prolonged antibiotic treatment. Every MRSA infection causes up to $ 10.000 additional costs. In the European Union more than 150.000 hospital patients get infected with MRSA each year. The associated health care costs for the European health care system are estimated to be 380 million Euro. An early, fast and systematic MRSA screening enables a specific treatment of infected patients and an introduction of appropriate hygiene interventions prevents a MRSA-transmission and spread. Conventional culture-based methods for detection of MRSA require 48 to 72 hours. Real-time PCR assays enable an early and rapid MRSA screening on the day of hospital admission as part of an infection prevention program (“search and destroy” strategy).
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months after production|
|Sensitivity||Analytical Sensitivity: ≥ 10 DNA copies per reaction|