Fda clearance for meridian premier campy eia campylobacter assay
The PREMIER™ CAMPY, a microtitre plate based EIA test for the detection of antigens found on Campylobacter jejuni and C. coli in stool samples from patients with signs and symptoms of Campylobacteriosis, has now received FDA clearance.
There is a significant need for the PREMIER™ CAMPY test because it provides a solution to several concerns associated with culture testing, currently the most commonly practiced lab technique for detecting the campylobacter bacteria. With culture, there is a potential for reduction in sensitivity due to variable culturing procedures, specimen viability, and inhibitory antibiotics in culture media. PREMIER™ CAMPY dramatically reduces these concerns with a consistent EIA method that measures the antigen instead of the fragile bacteria in an environment that is less inhibitory than current culturing procedures.
John A. Kraeutler, Chief Executive Officer, stated, 'PREMIER™ CAMPY is an important addition to our product portfolio given the prevalence of the disease. This new assay solidifies our position as a leader in rapid, accurate testing methods in food borne testing. PREMIER™ CAMPY, as well as our PREMIER™ and ImmunoCard STAT!® tests for toxigenic E. coli, provide acute care labs with highly accurate tools that can speed the detection of important pathogens and enable more rapid treatment of the patient. PREMIER™ CAMPY is already in distribution via Meridian Bioscience Europe for the Company´s European markets and was also recently approved for sale in Canada.'
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Source : Meridian Bioscience, Inc. View archived contact details
Posted on February 17, 2009