Novel Molecular Assay for Patient Screening Detects S. aureus and Newly Emerging MRSA Strains
Baltimore, MD - BD Diagnostics announced it has received FDA clearance to market the BD MAX™ StaphSR Assay for use on the fully-automated BD MAX™ System. The assay, with eXTended Detection Technology, accurately detects Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from nasal swabs, including mecA dropout mutants and new strains of MRSA that may not be detected by other assays.
The BD MAX StaphSR Assay is the first and currently the only commercially-available molecular assay in the United States that detects recently discovered MRSA strains with the mecC gene. Rapid, accurate detection of colonized patients enables effective strategies that can help reduce the risk of surgical-site infections (SSIs), improve patient safety and save healthcare costs.i,ii
"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate pre-surgical prophylaxis and direct appropriate utilization of isolation and decolonization," said Dr. Tobi Karchmer, Worldwide Vice President, Medical Affairs, BD Diagnostics. "With results available in approximately two hours compared to two or more days for culture methods, the BD MAX StaphSR Assay provides accurate and timely information to help physicians ensure safe and appropriate management of surgical patients."
With many commercial assays, SA strains carrying SCCmec where the mecA gene is absent (commonly called "dropout mutants") may be incorrectly detected as MRSA. These false positive results can lead to inappropriate use of vancomycin for surgical prophylaxis and unnecessary, expensive isolation of patients.iii MRSA strains with the recently discovered mecC gene account for nearly three percent of all new MRSA casesiv but cannot be detected by assays that do not detect that gene.v These false negative results can lead to inappropriate surgical prophylaxis in patients who should receive vancomycin to cover for MRSA and lack of appropriate isolation precautions to prevent transmission in the operating room and during hospitalization. Continue>
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