INTENDED USE

The Calprotectin Semi-Quantitative Rapid Test Kit (Feces) is a rapid chromatographic immunoassay for the semi-quantitative detection of Calprotectin in feces.

SUMMARY

Calprotectin, first described in 1980, is protein found in the cytosol of neutrophils and macrophages composed of two subunits S100A8 and S100A9. It is released extracellularly in times of cell stress or damage and can be detected within feces and thus can be used as a sensitive marker of intestinal inflammation. It is stable in feces for up to seven days at room temperature and has a homogenous distribution in feces, properties which lend it to testing spot fecal samples.
The inflammatory bowel diseases (IBD), Crohn’s disease and ulcerative colitis, are chronic relapsing, remitting disorders. Diagnosis along with assessment of disease activity and prognosis present challenges to managing clinicians. Fecal biomarkers, such as fecal calprotectin, are a non-invasive method which can be used to aid the sedecisions. Fecal protectin has been shown to be useful in the diagnosis of IBD, correlates with bowel mucosal disease activity and can help to predict response to treatment or relapse. With growing evidence supporting its use, over the last decade this fecal biomarker has significantly changed the way IBD is managed.

PRINCIPLE

The Calprotectin Semi-Quantitative Rapid Test Kit (feces) detects Calprotectin through visual interpretation of color development on the internal strip. Anti-Calprotectin antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-Calprotectin antibodies conjugated to colored particles and precoated on the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If Test line 2 (T2) appears, it indicates that the Calprotectin level in the specimen is between 50~200ug/g. If the test line 1 and 2 (T1 and T2) appear, it indicates that the Calprotectin level in the specimen is above 200ug/g. The appearance of control line serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.