The Kit is designed for the qualitative detection of the nucleic acid of Methicillin resistant Staphylococcus aureus (MRSA) in eluates from biological specimens. The assay is an in vitro diagnostic medical device and intended to be used by professional users in a laboratory environment. It can be performed manually or using an automated platform. The assay serves as an aid in the diagnosis, screening and monitoring of Methicillin resistant Staphylococcus aureus (MRSA).
2 Pathogen Information
Staphylococcus aureus are gram-positive coccal bacteria which are ubiquitously found in the environment. About 25-30 % of the human population are long-term carriers of S. aureus because the bacteria are frequently part of the skin flora found in the nose and on skin. S. aureus can cause a range of illnesses such as minor skin infections, like furuncles and abscesses, pyomyositis, but also life-threatening diseases such as pneumonia, endocarditis, toxic shock syndrome (TSS), and sepsis.
Of increasing importance worldwide are Methicillin-resistant Staphylococcus aureus (MRSA) strains. Especially in hospitals MRSA present a danger, because they are resistant to all ß-lactam antibiotics (e.g. penicillin) and often possess further resistances to other anitbiotics.
3 Principle of the Test
The diarellaMRSA 3.0 TM real time PCR contains specific primers and duallabeled probes for the amplification and detection of MRSA DNA in clinical specimens. The PCR targets the orfX/SSCmec junction and allows for the detection of MRSA in clinical samples, even those containing CoagulaseNegative Staphylococci. Furthermore,