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Comparison of three tests for faecal calprotectin in children and young adults: a retrospective monocentric study
Christine Prell1, Dorothea Nagel, Folke Freudenberg
1Division of Paediatric Gastroenterology and Hepatology, Dr. v. Haunersches Kinderspital, Ludwig-Maximilians-University, Munich, Germany.
Insights
Three fecal calprotectin assays show high sensitivity for detecting gastrointestinal inflammation in pediatric patients. However, significant differences in specificity and absolute values necessitate using the same assay for consistent disease monitoring.
Area of Science:
- Pediatric Gastroenterology
- Clinical Chemistry
- Biomarker Assay Performance
Background:
- Fecal calprotectin is a sensitive biomarker for gastrointestinal mucosal inflammation.
- Accurate measurement is crucial for diagnosing and monitoring inflammatory bowel disease (IBD) in children.
- Multiple assays exist, necessitating performance comparison.
Purpose of the Study:
- To compare the performance of three different fecal calprotectin assays.
- To evaluate assay accuracy in a cohort of symptomatic pediatric patients.
- To assess diagnostic classification of active IBD and controls.
Main Methods:
- Retrospective monocentric study of 304 symptomatic pediatric patients (aged 2-20 years).
- Patients included active IBD, IBD in remission, other intestinal diseases, and controls.
- Fecal samples were analyzed using three distinct calprotectin assays (EliA, PhiCal, EK-Cal).
Main Results:
- All assays demonstrated high sensitivity in classifying active IBD and controls.
- Assay C showed lower specificity compared to assays A and B.
- Concordance between assays A and B was highest (0.835), followed by A and C (0.782), and B and C (0.765).
Conclusions:
- While all three fecal calprotectin assays are sensitive for inflammation detection, significant differences in specificity and absolute values exist.
- Assay C tended to yield higher values and lower specificity.
- Consistent use of the same manufacturer's assay is strongly recommended for reliable patient follow-up and disease activity monitoring.
Objective:
Faecal calprotectin is used as a sensitive marker for gastrointestinal mucosal inflammation. We compared the performance of three different assays in a large cohort of symptomatic paediatric patients.
Design:
Retrospective monocentric study.
Setting:
Inpatients and outpatients of a tertiary referral centre for paediatric gastroenterology.
Participants:
304 symptomatic patients (163 males, aged 2-20 years) with active inflammatory bowel disease (IBD/A, n=130), IBD in clinical remission (IBD/R, n=62), other intestinal diseases (n=45) and controls without identified intestinal disease (n=67).
Interventions:
Calprotectin was measured in homogenised faecal samples with three tests (A: EliA Calprotectin, Phadia AB, Sweden; B: PhiCal, Calpro AS, Norway; C: EK-Cal, Bühlmann Laboratories, Switzerland).
Outcomes:
Concordance between tests was calculated using Kendall's τ coefficient.
Results:
IBD/A and controls were correctly classified as 97.7%/82.1% (A), 97.7%/85.1% (B) and 98.4%/62.7% (C; not significant). Test C tended to have higher calprotectin values with a lower specificity compared to tests A and B. The concordance between two tests was 0.835 for tests A and B, 0.782 for tests A and C and 0.765 for tests B and C.
Conclusions:
All three tests are very sensitive for detecting mucosal inflammation, but major differences exist between specificity and absolute values. It is highly advisable to use the test of the same manufacturer for follow-up and to monitor for disease activity.
