Meridian Bioscience announced that the Curian Campy assay has received U.S. Food and Drug Administration (FDA) clearance.
The Curian Campy assay is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen including C. jejuni, C. coli, C. upsaliensis, and C. lari in human fecal specimens. The assay was developed to be utilized on the Curian immunofluorescent testing platform.
Campylobacter infection, also known as campylobacteriosis, is one of the most widespread infectious diseases worldwide. This gastrointestinal disease presents with symptoms of acute watery or bloody diarrhea, abdominal pain, and fever. The symptoms usually occur 24 to 72 hours after ingestion, and the disease lasts up to six days.
The Curian Campy assay features s objective results in about 20 minutes.
Curian Campy is the second FDA-cleared assay on Meridian's expanding Curian testing platform. The Curian Analyzer and Curian HpSA assay received FDA clearance in March 2020.