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
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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