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OBJECTIVES: Hemophagocytic lymphohistiocytosis (HLH) is a severe condition requiring timely diagnosis to initiate immunomodulatory therapy. Soluble interleukin-2 receptor (sIL-2R) and soluble CD163 (sCD163) are biomarkers crucial for making this diagnosis. This study aims to establish pediatric reference intervals (RIs) for serum concentrations of sIL-2R and sCD163, and to evaluate the pre-analytic stability of sIL-2R. METHODS: Serum samples from 243 healthy children (aged 0-18 years) were analyzed to determine RIs for sIL-2R and sCD163. Samples were processed according to stringent pre-analytic protocols, with additional stability studies evaluating sIL-2R under various conditions, including temperature fluctuations and freeze-thaw cycles. The concentration of sCD163 was additionally determined in a protein reference material. RIs were calculated using non-parametric quantile regression, and subgroups were analyzed for potential partitioning by age, sex, and inflammation status (C-reactive protein (CRP) >8 mg/L). RESULTS: Discrete and continuous RIs were established for serum sIL-2R and sCD163 in healthy children, with distinct age-dependent variations observed for sIL-2R. Stability studies confirmed sIL-2R's robustness under common pre-analytic conditions. Results were consistent across samples obtained from general practitioners and hospital clinics, enhancing their transferability. CONCLUSIONS: This study provides comprehensive pediatric RIs for serum sIL-2R and sCD163 to support clinical decision-making in HLH and related inflammatory disorders. The stability of both sIL-2R and sCD163 under diverse conditions supports their reliable use in clinical settings. These findings may facilitate broader clinical implementation, pending on local validation and standardization.
Bruun et al. (Thu,) studied this question.
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