Luminex Corp. has received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices for the ARIES Flu A/B & RSV Assay. Designed for use with the FDA cleared and CE-IVD marked ARIES System, the ARIES Flu A/B & RSV Assay is a rapid and accurate method for the detection and differentiation of three key respiratory pathogens: Influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform.
“The ARIES Flu A/B & RSV Assay provides a rapid, automated and cost-effective way to inform actionable treatment decisions and manage outbreaks in markets accepting CE marking for clinical use,” said Thomas Pracht, Luminex’s managing director for EMEIA. “Combined with our comprehensive respiratory test menu, we believe the ARIES Flu A/B & RSV Assay provides the most flexible and complete clinical algorithm for improved patient outcomes.”
This is the second assay this year for which Luminex has received CE-IVD marking for use on the new ARIES System. The company received CE-IVD marking for the ARIES HSV 1&2 Assay in March 2016, and FDA clearance in October 2015, along with clearance of the ARIES instrument system.
The ARIES System is a sample to answer molecular diagnostic system designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today’s lean laboratory environment. ARIES uses internal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and Batch testing of IVD and homebrew assays using MultiCode Reagents when using a common Universal Assay Protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.
The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid from nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.