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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.
Abstract:
Plasma calprotectin is a promising new biomarker of inflammatory activity and has been found to correlate well with clinical and endoscopic activity in children and adolescents with inflammatory bowel disease. A pediatric reference interval for plasma calprotectin has not been established for the Phadia 250 EliA™ Calprotectin fluoroenzyme immunoassay. In studies regarding pre-analytical properties, excellent precision and stability was found. However, sensitivity to hemolysis was demonstrated. We identified pediatric blood samples from apparently healthy children who were referred by their general practitioner for blood sampling including measurement of hemoglobin (Hb) and C-reactive protein (CRP). We excluded samples from children who had undergone additional blood sampling within 2 months before or after the index sample, if Hb was outside of local reference ranges or CRP levels were above the lower limit of the measuring interval (LLM), and any samples with a hemolysis above 0.02 mmol/L. Using this algorithm, we identified 141 blood samples. No outliers were identified. We established the following reference intervals according to CLSI C28-A3 using non-parametric statistics: 1-17 years: 16-246 µg/L. Our results may prove useful for further utilization of plasma calprotectin as a marker of inflammation in children and adolescents with inflammatory disorders.
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