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bioMérieux Receives FDA Clearance for NucliSENS EasyQ® MRSA, Automated, Rapid Molecular Screening Test

bioMérieux announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NucliSENS EasyQ® MRSA, an automated molecular test for Methicillin Resistant Staphylococcus aureus (MRSA).

The test detects seven MRSA types, covering the most prevalent strains. The test also simultaneously detects two targets, which provides added confidence to the screening results. The EasyQ system will support efficient batch processing of up to 46 MRSA screening tests in a compact space with a rapid turn-around time of only three hours. Real-time actionable results enable more informed clinical decisions, which play an essential role in the management of antimicrobial resistance. Helping clinicians to take faster action to isolate patients and limit transmission is a critical issue, since MRSA is one of the leading causes of healthcare-associated infections (HAI). MRSA is also on the rise and has spread into the community. In the United States, MRSA infections alone kill nearly 19,000 people a year. Studies have shown that the frequency of MRSA transmission is reduced 38-fold if patients are identified and isolated. Systematic infection control measures, including MRSA screening, reduce the MRSA rate by 50%.

NucliSENS EasyQ MRSA complements chromID™ MRSA, bioMérieux’s chromogenic media, which enables direct, color-specific visual observation of the bacterial colonies in patient samples. bioMérieux can now offer hospitals and healthcare providers cost-effective alternatives for both culture-based and molecular-based MRSA screening. The complete suite of bioMérieux MRSA solutions also includes VITEK® 2 for rapid identification and antibiotic susceptibility testing, Etest® for extended dilution MICs (minimum inhibitory concentration), and DiversiLab® for strain typing.

The NucliSENS EasyQ MRSA test was cleared with a clinical sensitivity of 94.7% and a clinical specificity of 96.5% when testing nasal samples from adult patients. Additionally, the assay also received clearance with a clinical sensitivity of 100% and a clinical specificity of 97.3% when testing nasal samples from pediatric patients.

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