Inflammatory disease test kit

for antibodiesfor calprotectinEnterococcus faecalis

Product description
The Calprotectin Rapid Test is an in vitro qualitative immunochromatographic assay for the rapid detection of calprotectin in human feces. This test provides a simple, non-invasive screening tool to assess intestinal inflammatory activity, monitor therapeutic response and help predict relapse risk.

Intended use
The Calprotectin Rapid Test is intended for the qualitative detection of calprotectin in human feces as a non-invasive screening assay to determine intestinal inflammatory activity, monitor treatment response and predict the risk of relapse.

Principle
The kit uses a double antibody sandwich format. Gold-labeled mouse anti-human calprotectin monoclonal antibody 11F10, mouse anti-human calprotectin monoclonal antibody 2D1 and goat anti-mouse IgG polyclonal antibody are immobilized on the test strip to qualitatively detect calprotectin in fecal samples. In positive samples, calprotectin binds to the colloidal gold-labeled antibody; the complex migrates by capillary action and produces a visible red band at the test line. The control line captures excess gold-labeled antibody, confirming proper assay function. Negative samples show only the control line.

Operating Steps

• Bring tests, specimens, buffer and controls to room temperature (15–30°C) before use.
• Open the sealed pouch and place the test cassette on a clean, level surface. Label the device. Perform the assay within one hour of opening the pouch for best results.
• Using the provided disposable pipette, add 3 drops (≈75 μl) of specimen into the specimen well (S), then start the timer. Avoid air bubbles in the specimen well and do not apply liquid to the observation window.
• Allow the reaction to run; colored bands will migrate across the membrane. Read the result at 15 minutes. Do not interpret results after 20 minutes.

Characteristics / technical specifications

• Type: In vitro qualitative immunochromatographic assay (rapid test).
• Sample type: Human feces.
• Target analyte: Calprotectin.
• Method: Double antibody sandwich with colloidal gold labeling.
• Antibodies: Mouse anti-human calprotectin monoclonal antibodies (11F10 and 2D1) and goat anti-mouse IgG polyclonal antibody.
• Specimen volume: 3 drops (approximately 75 μl).
• Result time: Read at 15 minutes; do not interpret after 20 minutes.
• Intended use: Non-invasive screening for intestinal inflammatory activity, monitoring treatment response and predicting risk of relapse.