Roche announced that its new LightCycler test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) is now available with the CE Mark, allowing it to be sold for clinical use in the European Union. The LightCycler MRSA Advanced Test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with methicillin-resistant Staphylococcus aureus. The test will aid in the prevention and control of MRSA infections in healthcare settings resulting in better patient care.
"As more guidelines recommend or require aggressive screening, it is important that healthcare professionals have access to fast, reliable products that can help improve medical outcomes," said Daniel O'Day head of Roche Molecular Diagnostics. "This new test will aid infection control programs, and ultimately result in better patient care."
Healthcare-associated infections (HAIs) caused by MRSA have recently become an important issue for healthcare facilities worldwide due to high rates of infection, mortality, and high costs of treatment. In addition, community-associated MRSA (CA-MRSA) has spread in the past few years, feeding the pipeline of infection in hospitals, and underscoring the need for comprehensive infection control programs.
Dr Reinhard Frodl, Laboratory head of the Molecular Biology Department of Medizinisches Versorgungszentrum Dr Gärtner & Kollegen in Ravensburg, Germany commented, "The test showed good sensitivity and specificity in our hands and we believe it will bring more efficient MRSA screening to hospitals across Europe because of its batching flexibility and easy handling."
The LightCycler MRSA Advanced Test is performed on Roche's LightCycler 2.0 Instrument with nasal swab specimens from patients suspected of colonization, using Roche's patented real-time polymerase chain reaction (PCR) technology. Provided in a convenient, ready-to-use format, and designed for flexible batch sizes, the LightCycler MRSA Advanced Test ensures safety and productivity of laboratory staff, flexible throughput, and accurate and reliable results.
Staphylococcus aureus is responsible for many serious infections and is one of the most frequently isolated bacteria from patients with healthcare-associated infections (HAI). Estimates suggest that four million HAIs and 37,000 deaths are attributable to these infections each year in the EU, and that one out of 10 patients in an EU hospital acquires an HAI.
With more than 6,600 LightCycler Instruments in the market today, the LightCycler System is among the most widely utilized real-time amplification systems available.