US-based biotechnology firm Luminex has obtained CE-IVD mark for its qualitative in-vitro diagnostic test, ARIES Norovirus Assay.
The sample-to-answer test uses a real-time polymerase chain reaction (PCR) designed to quickly identify and distinguish norovirus genogroup I and II in stool specimens of people with acute gastroenteritis symptoms.
The assay can be used to simultaneously run a laboratory-developed test (LDT) and in-vitro diagnostic assay (IVD) in a sample-to-answer format at various laboratory shifts during the use of a universal assay protocol.
Luminex Europe managing director Thomas Pracht said: "The ARIES Norovirus Assay offers excellent performance for high confidence in results and reduced hands-on time compared to other molecular assays.
“By enabling rapid and accurate diagnosis even outside office hours, the assay can expedite appropriate infection control measures."
The Norovirus Assay expands the firm’s ARIES platform of systems that are developed to enhance laboratory efficiency and result accuracy.
The systems automate testing steps such as sample preparation and analysis, while providing quick results, and use features such as internal barcode scanning to reduce operator errors.
ARIES products are available with an integrated touchscreen PC, eliminating the necessity of a separate computer, standalone keyboard and mouse.
The ARIES Norovirus Assay belongs to the firm’s gastroenterological testing menu, comprising xTAG Gastrointestinal Pathogen Panel (GPP), VERIGENE Enteric Pathogens Test (EP), and ARIES C difficile Assay (RUO).
The assay is developed to be used in combination with clinical assessments, laboratory data, and epidemiological information to diagnose norovirus infections and identify them in the case of outbreaks.
Image: ARIES Norovirus Assay. Photo: courtesy of Luminex Corporation.