INTENDED USE
The AmeriDx® Calprotectin (CPTN) Rapid Test Kit is a qualitative test that detects CPTN antigen in human fecal specimens and other body fluids.
SUMMARY AND EXPLANATION
CPTN is a stool (fecal) marker for detecting inflammation in the intestines. Intestinal inflammation is associated with various bacterial infections and correlated to inflammatory bowel disease (IBD) activity and severity. AmeriDx® Calprotectin Rapid Test Kit is not diagnostic but may be used to distinguish between IBD and non-inflammatory disorders. It may also be used to monitor IBD disease activity. Multiple stool collections and tests are necessary to identify CPTN levels in patient.
TEST PRINCIPLE
AmeriDx® Calprotectin (CPTN) RapID Test Kit is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of a diluted stool sample is added into the sample well of the test cassette. The sample flows through a label pad containing CPTN antibody coupled to red-colored colloidal gold. If the sample contains CPTN antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary act
Sensitivity
92% (44/48) The detection limit was evaluated by diluting a pure recombinant CPTN ( 50 ng/mL) and results show that the CPTN antigen detected is of 50 ug/g fecal sample.
Specificity
An evaluation was conducted using 100 human stool samples. Results were compared with those of an immuno-enzymatic rapid test.