Molecular Diagnostic Test Rapidly Detects Seven MRSA Types

The test provides rapid results, with a turnaround time of less than three hours.

The real-time amplification assay for the screening of MRSA on the automated system NucliSENS detects a total of 7 MRSA types (MREJ types 1, 2, 3, 4, 5, 7, and 12) covering most resistant S. aureus strains frequently found. It offers flexible sample processing from 1 to 46 samples per run.

The test, called NucliSENS EasyQ MRSA, simultaneously detects two DNA targets, the SCCmec cassette junction (orfX), and the mecA gene. This reduces the risk of false-positive results and improves specificity. It avoids re-testing, inappropriate antibiotic treatment, and unnecessary isolation of patients.

A product of bioMérieux (Marcy l'Etoile, France), NucliSENS EasyQ MRSA is CE marked and will be submitted for 510(k) approval by the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) in the first half of 2010. Stéphane Bancel, bioMérieux CEO said, "At a time when reducing healthcare costs is paramount, we are proud to bring an automated molecular test that we are launching at an attractive price. More molecular tests for resistant bacteria, like VRE and C. difficile, will be launched in the future on our EasyQ platform."

NucliSENS EasyQ MRSA complements chromID MRSA, bioMérieux's chromogenic media, which enables direct, color-specific visual observation of the bacterial colonies in patient samples. With these two products, bioMérieux now offers hospitals and healthcare providers cost-effective alternatives for all patient situations: emergency and routine.

MRSA is one of the leading causes of nosocomial or healthcare-associated infections (HIA). The incidence of MRSA has been rising steadily over the past decade worldwide, and it is now found in the community. In some countries, more than 60% of S. aureus cases in hospital intensive care units are now resistant to not only methicillin but also to other first-line antibiotics. The frequency of MRSA transmission is reduced 38-fold if patients are identified and isolated. Systematic infection control measures, including MRSA screening reduces the MRSA rate by 50%.

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U.S. Food and Drug Administration