INTENDED USE

Diagnostic Kit for Calprotectin(cal) is is a colloidal gold immunochromatographic assay for the semiquantitative determination of cal from human faeces, which has important accessory diagnostic
value for inflammatory bowel disease. This test is a screening reagent. All positive sample must be
confirmed by other methodologies. This test is intended for healthcare professional use only.
Meanwhile, this test is used for IVD, extra instruments are not needed.
SUMMARY
Cal is a heterodimer, which is composed of MRP 8 and MRP 14. It exists in neutrophils cytoplasm
and expressed on mononuclear cell membranes. Cal is acute phase proteins, it has a well stable
phase about one week in human faeces, it is determined to be a inflammatory bowel disease marker.
The kit is a simple, visual semiqualitative test that detects cal in human faeces, it has high detection
sensitivity and strong specificity. The test based on high specificit double antibodies sandwich
reaction principle and gold immunochromatographic assay analysis technics, it can give a result
within 15 minutes.
PRINCIPLE OF THE PROCEDURE
The strip has anti cal coating McAb on test region and goat anti-rabbit IgG antibody on control
region, which is fastened to membrane chromatography in advance. Lable pad is coated by
colloidal gold labeled anti cal McAb and colloidal gold labeled rabbit IgG antibody in advance.
When testing positive sample, the cal in sample comined with colloidal gold labeled anti cal McAb,
and form immune complex, as it is allowed to migrate along the test strip, the cal conjugate
complex is captured by anti cal coating McAb on the membrane and form “anti cal coating
McAb-cal-colloidal gold labeled anti cal McAb” complex, a colored test band appeared on test
region. The color intensity is positively correlated with the cal content. A negative sample does not
produce a test band due to the absence of colloidal gold conjugate cal complex. No matter cal is
present in sample or not, there is a red stripe appear on reference region and quality control
region, which is regarded as quality internal enterprise standards.

Our CAL test is the first factory to get CFDA in China.We already ship to many countries with all positive response.

Welcome to contact us for more details.