The Calprotectin Rapid Test is a rapid chromatographic immunoassay (non-invasive assay) for the qualitative detection of calprotectin in human faeces specimens, which might be useful for the diagnosis of inflammatory gastrointestinal disorders. Only for research use.
Contents of Kit
1.Card tests 2.Instructions for use 3.Specimen collection vial with buffer
Storage
Store as packaged in the sealed pouch either at refrigerated or room temperature (2-30 °C/36-86 F). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. Do not freeze.
Performance Characteristics
Cut-off value of test is 500 ng/mL (50 ug hCp/g faeces) for human calprotectin.
Sensitivity
It was performed an evaluation using Calprotectin Rapid Test. The Calprotectin Rapid Test was evaluated compared with a commercial immunoassay (Calprest®, Eurospital). Sensitivity>94% and specificity 93%.
General Description
Calprotectin is a calcium-containing protein that makes up 5% of the total protein and 60% of the cytosolic protein of neutrophil. It has bacteriostatic and fungistatic properties and is found in faeces at levels six times higher than that in plasma. That fecal biomarker is useful to assess the activity of inflammatory bowel disease (IBD). IBD includes Crohn's Disease (CD) and Ulcerative Colitis (UC) and are associated with elevated neutrophils. This fecal calprotectin assay is useful in differentiating organic (IBD) from functional gastrointestinal disease (IBS: Intestinal Bowel Syndrome). It is a simple, non-invasive biomarker that is especially useful in children, who may require general anesthesia for colonoscopy. And this fecal calprotectin detection can predict relapse.
Citations
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Background
Calprotectin (CP) was first discovered in 1980. It is a small calcium and zinc-binding protein belonging to the S100 protein family and is a heterodimer of S100A8/A9. The S100 family comprises calcium-binding proteins, usually containing two EF-hand (helix E-loop-helix F), a central hinge, and N-terminal and C-terminal domains. S100A8 is also known as migration inhibitory factor-related protein 8 kDa or calgranulin A, and S100A9 is known as migration inhibitory factor-related protein 14 kDa or calgranulin B. Calprotectin mainly originates from neutrophils, accounting for approximately 60% of neutrophil cytoplasmic proteins, and is present in smaller amounts in monocytes and macrophages. Under healthy conditions, its concentration in feces is about six times that in plasma. When neutrophils infiltrate gastrointestinal tissues due to inflammation that damages the mucosa, the concentration of calprotectin in feces rises. Therefore, fecal calprotectin (FCP) concentration can positively reflect the severity of inflammation and has the potential to serve as a specific marker for gastrointestinal inflammation.
Inflammatory bowel disease (IBD) refers to a group of chronic debilitating diseases characterized by recurrent gastrointestinal inflammation, with an incidence rate exceeding 0.3%. IBD mainly includes ulcerative colitis (UC) and Crohn's disease (CD), which differ in their affected areas and progression. Table 1 compares some characteristics of UC and CD. The treatment methods for UC and CD may differ, with 10% of UC patients requiring a colectomy within 10 years of diagnosis, but CD patients generally have a poorer prognosis than UC. The application standards of calprotectin in their diagnosis and treatment also vary.
Figure 1. Clinical, endoscopic and histological features of CD and UC (Source: Khaki-Khatibi F, et al., 2020)
Over the years, various imaging techniques and endoscopy have been the mainstay for diagnosing IBD and irritable bowel syndrome (IBS). In the past decade, fecal biomarkers of gastrointestinal inflammation have emerged, with calprotectin being the most notable. Calprotectin can assess disease activity to distinguish between active and inactive IBD, correlating with the Crohn's Disease Severity Index (CDSI). Calprotectin can evaluate the therapeutic response in IBD to ensure sustained remission and ultimately achieve mucosal healing: when calprotectin is <250 μg/g, mucosal healing is determined, with a sensitivity of 94% and specificity of 62%. Calprotectin can predict the recurrence of IBD in patients in remission within the next year: when calprotectin >150 μg/g, the risk of relapse in UC patients increases 14-fold. Additionally, up to 20% of patients may require terminal ileum resection or colectomy for UC in their lifetime to treat CD. Calprotectin can predict postoperative recurrence of IBD, avoiding approximately 30% of colonoscopies and reducing patient discomfort. Fecal calprotectin may also play a role in the treatment of diseases such as acute appendicitis and cystic fibrosis, requiring further evidence to advance research.
Alternative Names
Fecal Calprotectin Rapid Test Calprotectin Lateral Flow Assay Calprotectin Point-of-Care Test Fecal Inflammation Test
References
1. Khaki-Khatibi F. et al.. Calprotectin in inflammatory bowel disease. Clinica Chimica Acta. 2020;510:556-565.
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