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Related Experiment Video

Updated: Jan 23, 2026

Implementation of Non-invasive Point of Care Transient Elastography for Evaluation of Liver Disease in Pediatric Populations with Cystic Fibrosis
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Validating CALIPER pediatric reference intervals in a U.S. population using retrospective outpatient data and

Jillian Kodger1, Thomas J S Durant2, Nalan Yurtsever1

  • 1Department of Laboratory Medicine, Yale School of Medicine, New Haven, CT, USA.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|January 21, 2026
PubMed
Summary

The RefineR method shows better alignment with Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) than CLSI guidelines for pediatric lab results. This approach is more accurate for diverse US pediatric outpatient populations.

Keywords:
Laboratory testing and CLSIPediatricReference intervalRefineR

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Area of Science:

  • Clinical Laboratory Medicine
  • Pediatric Reference Interval Development
  • Biostatistics in Healthcare

Background:

  • Accurate pediatric reference intervals (RIs) are crucial for interpreting lab results but face challenges like physiological variation and limited sample sizes.
  • This study assesses the applicability of Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) RIs in a diverse US pediatric outpatient setting.
  • Two methods, RefineR inverse modeling and Clinical and Laboratory Standards Institute (CLSI) EP28-A3c, were used for evaluation.

Purpose of the Study:

  • To evaluate the applicability of existing Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) to a US pediatric outpatient population.
  • To compare the performance of the RefineR inverse modeling approach versus the CLSI EP28-A3c recommended approach for deriving pediatric reference intervals.
  • To assess the accuracy and practicality of RefineR for developing population-specific pediatric reference intervals.

Main Methods:

  • Collected outpatient laboratory data from 51,863 pediatric patients (under 19 years) between January 2023 and December 2024.
  • Derived reference intervals (RIs) for nine common chemistry analytes using both RefineR and CLSI guidelines with bootstrap resampling.
  • Compared derived RIs to CALIPER RIs using a flagging system based on 95% confidence intervals and total allowable error (TAE).

Main Results:

  • RefineR-derived RIs aligned with CALIPER RIs in 86 out of 88 age- and gender-specific analyte groups.
  • CLSI-derived RIs showed alignment in 77 out of 88 groups, indicating lower concordance.
  • Discrepancies were noted for specific analytes (e.g., ALT, AST, ALP, BUN), influenced by factors like sample type, BMI, and hydration status.

Conclusions:

  • RefineR demonstrated superior alignment with CALIPER RIs compared to CLSI guidelines in a US pediatric outpatient cohort.
  • RefineR is a robust and practical method for deriving population-specific pediatric reference intervals, handling mixed data and skewed distributions effectively.
  • The RefineR approach aids in verifying the implementation of external RIs, such as CALIPER, in diverse pediatric populations.