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 Rapid Test Kit has two pre-coated lines, "(Test Line) and "C" (Control Line). Both lines are invisible before any sample is applied. The Control Line is used for the procedural control and should always appear when the test procedure is performed correctly. The Test Line will appear only when the Calprotectin antigen is present in the test sample. AmeriDx® Calprotectin Rapid Test Kit can identify Calprotectin in human fecal specimen samples and other specimen samples with a high degree of sensitivity and specificity. Th"test is a visual one step in vitro assay. It is intended for professional use to help to diagnose human IBD diseases.
The conjugate pad harbors the mouse anti-CPTN monoclonal antibody (detection antibody). When CPTN antigen is present in the sample fluid, the de