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Continuous reference intervals for 21 biochemical and hematological analytes in healthy Chinese children and
Ruohua Yan1, Yaguang Peng1, Lixin Hu2
1Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children Health, Beijing 100045, China.
Insights
This study establishes continuous pediatric reference intervals for 21 common laboratory analytes in China, addressing critical gaps for children aged 3 months to 20 years. These new intervals improve interpretation of laboratory test results for better clinical decisions.
Area of Science:
- Clinical Chemistry
- Pediatric Laboratory Medicine
- Reference Intervals
Background:
- Established pediatric reference intervals in China are lacking, hindering accurate interpretation of laboratory results.
- Accurate reference intervals are crucial for diagnosing and monitoring health conditions in children and adolescents.
Purpose of the Study:
- To establish continuous pediatric reference intervals for 21 common laboratory analytes in China.
- To present sex and age distributions for these analytes from childhood to adolescence.
- To provide a foundation for improved clinical decision-making in pediatric healthcare.
Main Methods:
- Utilized data from the Pediatric Reference Intervals in China (PRINCE) study, a nationwide cross-sectional survey of 15,150 healthy children and adolescents.
- Collected and analyzed blood samples following standardized procedures, with biochemical tests on Cobas C702 and hematological tests on Sysmex platforms.
- Calculated continuous reference intervals using generalized additive models for location, shape, and scale, excluding neonates due to variability.
Main Results:
- Presented continuous pediatric reference intervals for 21 biochemical and hematological analytes in China.
- Depicted analyte concentration changes from 3 months to 20 years of age.
- Demonstrated applicability with <10% out-of-range values in the general pediatric population.
Conclusions:
- This is the first comprehensive report of continuous reference intervals for healthy Chinese children, capturing dynamic analyte trends.
- Continuous reference intervals enhance laboratory test interpretation and support better clinical decision-making.
- These findings are vital for advancing pediatric diagnostics and healthcare in China.
Objectives:
Critical gaps have existed in pediatric reference intervals in China. In this study, we presented the sex and age distributions of 21 laboratory analytes from childhood to adolescence, and established the corresponding continuous reference intervals based on direct samples.
Methods:
We used the data from the Pediatric Reference Intervals in China (PRINCE), which is a nation-wide cross-sectional study enrolling 15,150 healthy children and adolescents aged 0 - <20 years from 11 centers across China. Blood samples were collected and analyzed by trained staff following standard operating procedures. Biochemical tests were performed with Cobas C702 at the central laboratory, and hematological tests were performed with Sysmex XE, XN, or XS that satisfy the national standards at each participating center. Children younger than 3 months were excluded due to high neonatal variability and insufficient samples. Continuous reference intervals were calculated using the generalized additive models for location, shape, and scale, and were validated among another 387 healthy volunteers.
Results:
We provided pediatric continuous reference intervals for 21 commonly used biochemical and hematological analytes in China, and depicted the changes in analyte concentrations from 3 months to 20 years. The out-of-range values for all analytes were less than 10%, indicating a well applicability of the continuous reference intervals to the general pediatric population.
Conclusions:
This is the first comprehensive report of continuous reference intervals based on healthy Chinese children, reflecting the complex dynamic trends of analytes from infancy to adulthood. Applying continuous reference intervals to clinical practice would not only improve the laboratory test result interpretation, but also help better clinical decision making.
