GHM Calprotectin Antigen Rapid Test US – Semi-Quantitative Detection of Fecal Calprotectin with 10-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Calprotectin Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Calprotectin Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the semi-quantitative detection of calprotectin in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of inflammatory gastrointestinal disorders, including inflammatory bowel disease (IBD).

Calprotectin is a calcium- and zinc-binding protein found in the cytosol of neutrophils, and its concentration in feces is directly proportional to neutrophil migration into the intestinal mucosa. Fecal calprotectin (FC) has emerged as a leading non-invasive biomarker for detecting and monitoring intestinal inflammation, with clinical guidelines supporting its use for differentiating inflammatory bowel disease (IBD)—including Crohn’s disease (CD) and ulcerative colitis (UC)—from irritable bowel syndrome (IBS). The use of fecal calprotectin significantly reduces the need for unnecessary colonoscopy procedures while identifying patients with a higher likelihood of IBD, allowing for better management of colonoscopy resources and reducing associated costs.

Fecal calprotectin demonstrates superior performance compared to serum biomarkers such as C-reactive protein (CRP) for assessing IBD activity, with reported sensitivity for CRP estimates as low as 50%. FC measurement correlates well with endoscopic disease activity and histological scores, and is recommended for monitoring disease activity during pregnancy in patients with IBD, as FC concentrations remain stable throughout all trimesters, unlike other serum biomarkers affected by physiological pregnancy-related changes.

The GHM Calprotectin Antigen Rapid Test US delivers semi-quantitative results in just 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human feces specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical settings.

The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including gastroenterology clinics, primary care clinics, hospital laboratories, and clinical laboratories. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.

Key Features & Benefits

Colloidal Gold Immunochromatography – Reliable Semi-Quantitative Detection

The GHM Calprotectin Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to calprotectin, along with immobilized capture antibodies on the test line. The test provides semi-quantitative results by comparing the intensity of the test line against a reference scale, enabling healthcare professionals to estimate the concentration of calprotectin in the specimen.

Fast Results – 10 Minutes

The GHM Calprotectin Antigen Rapid Test US provides semi-quantitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Traditional ELISA-based FC testing is time-consuming and impractical in point-of-care settings, often resulting in clinical management delays of up to several days. Rapid FC testing addresses these limitations by delivering actionable results within minutes.

Feces Sample Compatibility – Simple and Non-Invasive Collection

The GHM Calprotectin Antigen Rapid Test US is compatible with human feces specimens, providing a simple and non-invasive sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Fresh stool specimens are recommended for optimal results.

Clinical Utility – Aid for Diagnosis of Inflammatory Gastrointestinal Disorders

The GHM Calprotectin Antigen Rapid Test US is intended for use as an aid in the diagnosis of inflammatory gastrointestinal disorders, including IBD. The test provides rapid semi-quantitative detection of fecal calprotectin, enabling timely clinical decision-making and supporting patient management.

The test is particularly valuable in settings where rapid identification of intestinal inflammation supports timely clinical intervention and appropriate use of invasive diagnostic procedures. Fecal calprotectin less than 50 μg/g is highly effective in ruling out endoscopic activity, including postoperative Crohn disease recurrence. Published literature supports the use of FC testing to monitor disease activity during pregnancy in patients with IBD, with FC remaining stable throughout all trimesters. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Calprotectin Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against ELISA reference methods has demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.

Performance characteristics based on product specifications. Published evaluations of rapid fecal calprotectin tests have reported sensitivities ranging from 87.2% to 100% and specificities ranging from 96.3% to 100%, depending on the product, population, and reference method used. A comparative evaluation of rapid immunochromatographic assays reported a sensitivity of 87.2% and a specificity of 96.3% compared with ELISA, with almost perfect agreement (Cohen’s κ = 0.85). Meta-analyses report pooled sensitivities of ~95% and specificities around 91% for FC in differentiating IBD from non-IBD conditions. Detection is optimal when specimens are collected and processed according to the manufacturer's instructions, and the test is best suited for use as an aid in the diagnosis of inflammatory gastrointestinal disorders in symptomatic patients.

ISO 13485 Certified – Quality and Safety Compliance

The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.

CE Marked – European Conformity

The GHM Calprotectin Antigen Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.

Product Specifications

Why Clinical Professionals Choose Global Healthcare Medical

About Global Healthcare Medical

Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Calprotectin Antigen Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.

Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.