The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.
The Calprotectin Chemiluminescence ELISA is the most clinically accurate test on the market and provides the following:
The best combination of clinical specificity (95.1%) and clinical sensitivity (92.1%) when used as an aid in the differentiation of IBD from IBS.
The broadest range from the primary dilution of 7.9 - 6,000 ug/g.
The lowest false positive rate of any calprotectin test on the market.
Fast time to results with an assay run time of only 1 hour 32 minutes.
FDA 510(k) Cleared. For In Vitro Diagnostic Use , Health Canada Licensed
FDA 510(k) Cleared. For In Vitro Diagnostic Use, Health Canada Licensed
Product Distribution
Available in North America Only
Range
7.9 - 6,000 ug/g
Sensitivity
7.9 ug/g
Sizes
96 Wells
Sample Types
Stool
Inc Time Hour
1
Inc Time Minute
32
Inc Time Overnight
No
Inc Time See Protocol
No
Sample Size
15
Detection
Chemiluminescence
• 95.1% Clinical Specificity • 92.1% Clinical Sensitivity • Broad range for repotrable results at a single sample dilution • Accurate, user-friendly fecal sample processing • In-house sample reference panel for lot-to-lot consistency • Convenient Validation Assistance Program • FDA cleared and Health Canada Licensed
ALPCO’s automated turbidimetric solution for calprotectin testing offers enhanced efficiency without compromising clinical sensitivity or specificity. Clinicians can prioritize endoscopic evaluation for the patients that need it most and quickly put IBS patients on the right treatment path.
Join our speaker from Department of Pathology , University of Utah School of Medicine, Dr. Heather Nelson, to discuss how to validate and launch a FDA-approved assay.
ALPCO offers targeted GI solutions suitable for all types of labs. Our offerings range from plate-based to clinical chemistry analyzer-based and automated flash chemiluminescence solutions, all designed to accommodate your lab’s expanding testing needs and capabilities.
In the webinar, Dr. Benjamin Click from the University of Colorado, Department of Gastroenterology, underscores the critical role of non-invasive monitoring methods, particularly fecal calprotectin monitoring, in guiding treatment adjustments and achieving therapeutic goals..
This infographic distills the essence of the new American Gastroenterological Association (AGA) Clinical Practice Guideline on the Role of Biomarkers in Crohn's Disease (CD). It sheds light on the nuanced recommendations for using biomarkers to monitor and evaluate CD, emphasizing their value in conjunction with clinical symptoms.
In an effort to improve patient care, an increasing number of gastroenterologists are using fecal calprotectin levels as a first step in the diagnosis of IBD versus IBS. ALPCO tests enable clinicians to accurately assess patients via calprotectin and quickly start patients on the right treatment path.
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Join our speaker from Department of Pathology , University of Utah School of Medicine, Dr. Heather Nelson, to discuss how to validate and launch a FDA-approved assay.
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