Establishing a pediatric reference interval for plasma calprotectin

Anne-Birgitte Garm Blavnsfeldt1, Tina Parkner1, Cindy Soendersoe Knudsen1

  • 1Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.

Insights

This study establishes the first pediatric reference interval for plasma calprotectin, a key inflammatory biomarker, using the Phadia 250 assay. The findings provide crucial data for diagnosing inflammatory conditions in children and adolescents.

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.

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