ARIES Flu A/B & RSV Assay receives EU CE mark approved for influenza and RSV- Luminex Corp
Luminex Corporation announced that it has received CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices for the ARIES Flu A/B & RSV Assay, a rapid and accurate diagnostic 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.
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 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.
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