14th October 2019 Product update: Paul Carton
FDA Approve Nasal Swab MRSA Assay That Gives Results in Under 2 Hours
Luminex Corporation has received US FDA 510(k) clearance for its real-time PCR-based ARIES® methicillin-resistant Staphylococcus aureus (MRSA) Assay.
The assay is an integrated, real-time, polymerase chain reaction (PCR) based, qualitative, in vitro diagnostic test for the direct detection of MRSA DNA from nasal swabs in patients at risk for nasal colonization.
According to U.S. Centres for Disease Control and Prevention, approximately one in 50 people in the U.S are colonized with MRSA in their nose. To increase the confidence in an MRSA call, the ARIES® MRSA Assay includes mecA/mecC resistance gene detection, and SCCmec and orfX targets to ensure the resistance gene is associated with and present in S. aureus.
The system can run up to 12 ARIES® assays simultaneously including MRSA, C.difficile and Group B Strep. It also provides a ‘built-in patient safety’ feature which relies on an internal barcode scanner that reduces the risk of sample input errors.
The ARIES® system streamlined workflow, which requires the operator to perform six simple steps, delivers a rapid turnaround time of under two hours from sample preparation to result.
The Luminex ARIES® system now has six FDA and seven CE-IVD cleared assays and can also run laboratory-developed tests.
Date Published: 14th October 2019
Source article link: View
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.