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Clinical Performance of Fecal Calprotectin Reagents Based on the Colloidal Gold Agglutination Method for Evaluating the Differential Diagnosis between Inflammatory Bowel Disease and Irritable Bowel Syndrome in Adults and Children with Gastrointestinal Symptoms (SCALE 1).
Inflammatory intestinal diseases

Cure8 research brief

Clinical Performance of Fecal Calprotectin Reagents Based on the Colloidal Gold Agglutination Method for Evaluating the Differential Diagnosis between Inflammatory Bowel Disease and Irritable Bowel Syndrome in Adults and Children with Gastrointestinal Symptoms (SCALE 1).

2 min read

Why This Matters

Fecal calprotectin is a noninvasive test commonly used to tell inflammatory bowel disease from IBS and to monitor IBD activity. This study validates a specific CGA assay and suggests a high-specificity cutoff that could reduce unnecessary procedures and help assess pediatric UC activity.

Who Should Pay Attention

Patients with suspected or established IBD, parents and caregivers of children with UC, gastroenterologists, and clinical laboratorians evaluating fecal calprotectin assays.

Study Snapshot

Story typeResearch paper
Evidence typeResearch paper
Source depthJournal abstract

What To Know

The study tested FC by the CGA method in 285 patients (205 UC, 24 Crohn's disease, 56 IBS) across eight centers and compared FC levels with endoscopic scores. Using a 500 µg/g cutoff, FC showed very high specificity (98%) for separating active-phase IBD from IBS.

The paper notes that summing segmental endoscopic scores (cumulative scores) may better reflect disease activity in children with UC and that FC measured by CGA is a reliable biomarker for this purpose.

How this might affect you: If your care team uses fecal calprotectin, this study supports the CGA assay as a useful tool to help tell active IBD from IBS and to reflect endoscopic activity, particularly in pediatric UC.

Discuss with your clinician how FC cutoffs are applied in your local lab and how results will be interpreted along with symptoms and endoscopy.

Keep In Mind

Structured content depth: abstract. This summary is grounded in the article abstract provided by the journal; Cure8 did not review the full peer-reviewed manuscript beyond the supplied text. Assay performance and chosen cutoffs can vary by lab and population; local clinical context and endoscopic assessment remain important.

Source Details

Review the original publication for the complete reporting, methods, and context.

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Research paper Evidence type derived from source or registry metadata.
PublicationInflammatory intestinal diseases
AuthorsYamakawa T, Hara T, Wagatsuma K +20 more
Study typeJournal article
Indexed viaEurope PMC
Source typeResearch paper
PublishedJan 1, 2026, 12:00 AM
Content availableJournal abstract

This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.

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