Establishing a pediatric reference interval for plasma calprotectin

Area of Science:

• Biochemistry
• Pediatric Medicine
• Clinical Diagnostics

Background:

• Plasma calprotectin is a valuable biomarker for inflammatory activity in pediatric inflammatory bowel disease.
• A validated pediatric reference interval for plasma calprotectin using the Phadia 250 EliA™ Calprotectin assay is currently lacking.
• Pre-analytical studies show good precision and stability, but highlight sensitivity to hemolysis.

Purpose of the Study:

• To establish a pediatric reference interval for plasma calprotectin using the Phadia 250 EliA™ Calprotectin fluoroenzyme immunoassay.
• To provide a benchmark for interpreting plasma calprotectin levels in children and adolescents.
• To support the clinical utility of plasma calprotectin as an inflammatory marker in pediatric populations.

Main Methods:

• Identification of 141 pediatric blood samples from apparently healthy children.
• Exclusion criteria included recent blood sampling, abnormal hemoglobin (Hb) or C-reactive protein (CRP) levels, and significant hemolysis.
• Application of Clinical and Laboratory Standards Institute (CLSI) C28-A3 guidelines with non-parametric statistical analysis.

Main Results:

• A reference interval for plasma calprotectin was established for children aged 1-17 years as 16-246 µg/L.
• No statistical outliers were identified in the selected pediatric sample cohort.
• The established reference interval adheres to CLSI guidelines for diagnostic testing.

Conclusions:

• The study successfully established a pediatric reference interval for plasma calprotectin using the Phadia 250 assay.
• This reference interval is essential for accurate interpretation of plasma calprotectin in pediatric inflammatory conditions.
• The findings facilitate the broader use of plasma calprotectin as a reliable inflammatory marker in children and adolescents.