Inflammatory disease test kit

for calprotectinfor lactoferrinenterovirus

Product overview
The Calprotectin and Lactoferrin Combo Rapid Test is an in vitro qualitative immunochromatographic assay for the simultaneous detection of human calprotectin and lactoferrin in stool samples. These biomarkers indicate intestinal inflammation associated with conditions such as inflammatory bowel disease (IBD), colorectal cancer and certain enteropathies. The test provides a simple, non-invasive screening method to assess intestinal inflammatory activity, support diagnosis, monitor therapy response and help predict relapse risk.

Intended use
This rapid test is intended for qualitative detection of calprotectin and lactoferrin in stool specimens to indicate gastrointestinal inflammation and assist clinical evaluation of inflammatory intestinal diseases and related conditions.

Principle
The assay uses colloidal gold immunochromatography. Gold-labeled mouse anti-human calprotectin monoclonal antibody 11F10 and gold-labeled mouse anti-human lactoferrin monoclonal antibody 13H1 are immobilized on the conjugate pad. Capture antibodies (mouse anti-human calprotectin 2D1, mouse anti-human lactoferrin 5A4) and goat anti-mouse IgG polyclonal antibody are coated on the membrane to bind target analytes and produce visible lines for qualitative interpretation.

Operating Steps

• Bring tests, specimens, buffer and controls to room temperature (15–30°C) before use.
• Open the sealed pouch and place the device on a clean, level surface. Label with patient or control ID. Use within one hour of opening.
• Add 3 drops (~75 μl) of stool specimen to the specimen well (S) using the provided disposable pipette, then start the timer.
• Avoid introducing air bubbles into the specimen well and do not add solution to the observation window.
• As the assay runs, colored bands will migrate across the membrane and appear at the test and control lines.
• Read results at 15 minutes. Do not interpret after 20 minutes.

Notes
Qualitative, non-invasive screening intended to assist clinical diagnosis, monitor treatment response and aid relapse risk assessment. For use with stool specimens only.

Caractéristiques / spécifications techniques

• Sample type: Stool
• Analytes: Calprotectin and Lactoferrin
• Assay format: Colloidal gold immunochromatographic rapid test (qualitative)
• Gold-labeled detection antibodies: Mouse anti-human calprotectin monoclonal antibody 11F10; mouse anti-human lactoferrin monoclonal antibody 13H1
• Capture antibodies: Mouse anti-human calprotectin monoclonal antibody 2D1; mouse anti-human lactoferrin monoclonal antibody 5A4; goat anti-mouse IgG polyclonal antibody
• Specimen volume: 3 drops (~75 μl)
• Incubation / read time: Read at 15 minutes; do not interpret after 20 minutes
• Working temperature: 15–30°C (bring components to room temperature before use)
• Intended applications: Screening for intestinal inflammation, supporting diagnosis of inflammatory intestinal diseases, monitoring treatment response, predicting relapse risk
• Result type: Qualitative (presence/absence and band intensity)