Clinica chimica acta; international journal of clinical chemistry · 2026
Validating CALIPER pediatric reference intervals in a U.S. population using retrospective outpatient data and RefineR.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Kodger Jillian, Durant Thomas J S, Yurtsever Nalan, El-Khoury Joe M
Аннотация
BACKGROUND: Accurate pediatric reference intervals (RIs) are critical for proper interpretation of laboratory results, yet their development is challenged by age-related physiological variation, limited sample sizes, and preanalytical variability. This study evaluates the applicability of the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) RIs to a US-based, diverse pediatric outpatient population using both the RefineR inverse modeling approach and the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c recommended approach.
METHODS: Outpatient laboratory data from 51,863 patients under 19 years of age were collected from a single institution between January 2023 and December 2024. Nine commonly ordered chemistry analytes were evaluated. RIs were derived using both RefineR and CLSI guidelines with bootstrap resampling. These were compared to CALIPER RIs using a color-coded flagging system based on 95% confidence intervals and total allowable error (TAE).
RESULTS: RefineR-based RIs aligned with CALIPER values in 86 out of 88 age- and gender-specific analyte groups, whereas CLSI-derived RIs aligned in 79 out of 88. Notable discrepancies involved alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and blood urea nitrogen, often influenced by known preanalytical and physiological variables such as sample type, body mass index (BMI), and hydration status.
CONCLUSIONS: RefineR demonstrated superior alignment with CALIPER RIs compared to CLSI guidelines, highlighting its robustness in outpatient pediatric populations. Given its tolerance to mixed data and skewed distributions, RefineR offers a more practical and accurate method for deriving population-specific RIs in pediatric laboratory medicine, and helps verify the implementation of external RIs, such as CALIPER.
METHODS: Outpatient laboratory data from 51,863 patients under 19 years of age were collected from a single institution between January 2023 and December 2024. Nine commonly ordered chemistry analytes were evaluated. RIs were derived using both RefineR and CLSI guidelines with bootstrap resampling. These were compared to CALIPER RIs using a color-coded flagging system based on 95% confidence intervals and total allowable error (TAE).
RESULTS: RefineR-based RIs aligned with CALIPER values in 86 out of 88 age- and gender-specific analyte groups, whereas CLSI-derived RIs aligned in 79 out of 88. Notable discrepancies involved alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and blood urea nitrogen, often influenced by known preanalytical and physiological variables such as sample type, body mass index (BMI), and hydration status.
CONCLUSIONS: RefineR demonstrated superior alignment with CALIPER RIs compared to CLSI guidelines, highlighting its robustness in outpatient pediatric populations. Given its tolerance to mixed data and skewed distributions, RefineR offers a more practical and accurate method for deriving population-specific RIs in pediatric laboratory medicine, and helps verify the implementation of external RIs, such as CALIPER.