INTENDED USE

Calprotectin test is a single use rapid membrane immunoassay for the qualitative detection of calprotectin in human faecal samples, which may be of use in the diagnosis of inflammatory gastrointestinal disorders. For In Vitro Diagnostic Use.

SUMMARY

Calprotectin is a calcium)*ontaining protein that makes up 5% of the total protein and 60% of the cytosolic protein of neutrophils. It has bacteriostatic and fungistatic properties and is found in faeces at levels six times higher than that in plasma. This faecal biomarker is useful to assess the activity of inflammatory bowel disease (IBD). IBD includes Crohn’s disease (CD) and ulcerative colitis (UC) which are associated with elevated neutrophils.
This faecal calprotectin assay is useful in differentiating IBD from functional irritable bowel syndrome (IBS). It is a simple, non) nvasive biomarker that is especially useful in children, who may require general anaesthesia for colonoscopy.

PRINCIPLE

Calprotectin test is a single use rapid membrane immunoassay for the qualitative detection of calprotectin antigen in human faecal samples.
Monoclonal antibodies to calprotectin antigen are coated onto the test line region of the strip. During testing the sample migrates along the membrane by capillary action and is allowed to react with the conjugate on the test strip. In the case of a positive result the specific antibodies present on the membrane will capture the coloured conjugate.
A green line should always appear in the control line region to show that sufficient volume was added, proper flow was obtained and the reagents functioned correctly. Failure of the control line to appear, whether or not test lines are present, indicates an invalid assay. The test is interpreted by the presence or absence of visibly detectable coloured lines in the test region at 10 minutes or less depending on the concentration of antigen present.
A positive result will show a pink/red test line and a green control line, indicating that calprotectin antigen is present in the sample. A negative test result, read at 10 minutes, will show only a green control line, indicating that calprotectin antigen was not detectable in the sample.