Premier® CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis.
It detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary-Blairbased transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures. It is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.
It is an enzyme immunoassay for the direct detection of Campylobacter antigens in human stool samples. Breakaway microwells are coated with Campylobacter-specific monoclonal antibodies. Diluted patient specimen is added to the microwells and incubated. Upon completion of the incubation, a wash step is performed to remove unbound material and a Horseradish Peroxidase (HRP)–Anti–Campylobacter conjugate is added to the washed microwells. If Campylobacter antigens are present, an antibody-enzyme complex is formed. A second wash step is performed to remove unbound materials and a chromagen substrate is added to the microwells. A blue color develops in the presence of bound enzyme. Premier® Stop Solution I is added, changing the initial blue reaction to yellow. Test results are interpreted visually or spectrophotometrically.