New Assay FDA-Cleared for Detecting Major Respiratory Pathogens
Luminex announced that the Food and Drug Administration (FDA) has granted clearance for the ARIES Flu A/B & RSV Assay to detect and differentiate 3 key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
The ARIES Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test that detects and differentiates the nucleic acid of the 3 pathogens of nasopharyngeal swab specimens, from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.
The new assay delivers test results in less than 2 hours for the pathogens using a sample to answer platform. This allows for panel customization with the capability to report specific results. The ARIES System utilizes internal barcode scanning and other features to reduce operator errors. Separate modules support 1 to 6 cassettes, allowing both STAT and Batch testing of IVD assays and lab-developed tests.
The ARIES Flu A/B & RSV Assay is cleared for use on the Luminex ARIES System. The test is not intended to detect influenza C.
For more information call (877) 785-2323 or visit LuminexCorp.com.