Luminex Corporation has received FDA clearance for the ARIES Flu A/B & RSV Assay. This is the second assay the FDA has cleared for use on the Luminex ARIES System.
The ARIES Flu A/B & RSV Assay delivers results in less than two hours 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. This new assay also allows for panel customization with the unique ability to only report the results of interest. The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C.
“Clinical labs everywhere are trying to accomplish more with less these days, so we need each instrument to perform more tasks,” said Dr. Stefan Juretschko, Director, Infectious Diseases Diagnostics, Northwell Health. “The ARIES platform lets us run samples as they come in and turn results around quickly.”
Luminex has also received FDA clearance for the ARIES HSV 1&2 Assay for use on the ARIES Systems. Both the HSV 1&2 and Flu A/B & RSV assays have also received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.