Roche Molecular Systems has received FDA clearance for its new LightCycler MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the US. The molecular test is expected to help healthcare facilities control spread of methicillin-resistant Staphylococcus aureus (MRSA).
The LightCycler MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA, and is designed to aid in the prevention and control of MRSA infections in healthcare settings.
Roche’s new real-time polymerase chain reaction (PCR) test delivers rapid results (within two hours) and appears to have better sensitivity compared to direct culture-based methods.
The LightCycler MRSA Advanced Test is performed on Roche’s LightCycler 2.0 Instrument with nasal swab specimens from patients suspected of MRSA colonization. The test is intended to help ensure the safety and productivity of laboratory staff and provides flexible throughput with accurate, reliable results as it is offered in a convenient, ready-to-use format and designed for flexible batch sizes.
Paul Brown, president and CEO of Roche Molecular Diagnostics, said: “It is important that healthcare professionals have access to MRSA testing technology that provides rapid and reliable results, allowing faster implementation of appropriate infection control measures.
“Roche’s new LightCycler MRSA Advanced Test is designed to offer a simple, flexible, and reliable method for MRSA screening to support hospitals in the prevention of MRSA infections.”
Lance Peterson, epidemiologist and a founder of the MRSA screening program at NorthShore University HealthSystem in Evanston, Illinois, said: “The introduction of this new advanced test will expand the options healthcare facilities have for MRSA screening using molecular diagnostic methods. The test showed good sensitivity with minimal hands-on time. Technicians now have the ability to have flexible batch sizes which could make it the cost-effective choice for many hospital laboratories.”