Elsevier

Clinica Chimica Acta

Volume 490, March 2019, Pages 142-146
Clinica Chimica Acta

Pediatric reference intervals of liver and renal function tests from birth to adolescence in Chinese children as performed on the Olympus AU5400

https://doi.org/10.1016/j.cca.2019.01.001Get rights and content

Highlights

  • We reported reference intervals for 15 hepatic and renal function parameters.

  • We established such reference intervals using nonparametric rank method.

  • Data were obtained from 63,086 samples of apparently healthy children.

  • Other clinical laboratories use the reference intervals after validation.

Abstract

Background

The growth and development of children and adolescents influence values of liver and renal function tests. The purpose of this study was to determine age- and gender-specific reference intervals for liver and renal function tests in apparently healthy Chinese children and adolescents.

Methods

A total of 63,086 apparently healthy children and adolescents (0–15 y) were chosen as reference individuals in this study. The 15 biochemical analytes relating to liver and renal function were measured using an Olympus AU5400 analyzer. Reference intervals were partitioned according to age and/or gender subgroups using the Harris and Boyd's method and established using non-parametric methods.

Results

Our results showed that all analytes except for cholinesterase (ChE) and α1-microglobulin (α1-MG) required partitioning by age. Gender partitions were also required for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), creatinine (Cre), and uric acid (UA). Age- and gender-appropriate reference intervals for liver and renal function tests were established for apparently healthy Chinese children and adolescents.

Conclusions

When establishing pediatric reference intervals, partitioning by age and/or gender is essential. Those reference intervals can be adopted in other clinical laboratories after appropriate validation.

Introduction

Clinicians rely on the availability of reliable and suitable reference intervals to decide whether patients require further testing and examination. Liver and renal function tests can be useful to determine whether the liver and kidney are performing their tasks adequately. Therefore, these tests are an important part of routine health checks.

Many of clinical laboratories adopt the reference intervals reported by the medical literature or the diagnostic test manufacturer [1]. As we know, reference intervals provided by manufacturers were established mainly based on American and European populations. Given that laboratory test results could be influenced by differences in dietary, genetic, environmental, and social factors, using reference intervals derived from foreign population may lead to a wrong interpretation, which might influence the outcome. In addition, the clinical interpretation of these results in pediatrics is executed in the context of age- and gender-specific dynamics because physiological development leads to changes in many analytes measured, particularly during puberty and in the first ys of life [2]. Clinical laboratories should define reference intervals based on the local population.

However, establishing pediatric reference intervals is challenging [[2], [3], [4]]. On the one hand, obtaining sufficient samples from healthy children is challenging. On the other hand, reference interval value can be different due to gender and age. Appropriate pediatric reference intervals are often inadequate or even unavailable.

Section snippets

Study population

This study was approved by the institutional ethics committee of the Third Affiliated Hospital of Zhengzhou University. According to the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c guidelines [5], we enrolled a total of 65,735 apparently healthy children and adolescents (0–15 y) between January 2016 and June 2018 from our hospital. The exclusion criteria were as follows: 1. diabetes mellitus, anemia, renal disease, hepatic disease or other diseases that may affect analytes

Results

The reference population started with 65,735 apparently healthy children and adolescents (0–15 y) from our hospital. After applying these exclusion criteria, our study included 63,086 subjects. Subsequently, one outlier was detected in ChE and Cre. Two outliers were detected in BUN. Three outliers were detected for ALP, TP, Alb, TBIL, α1-MG, and Cys -C. Four outliers were detected in ALT, GGT, Cre, and UA. Five outliers were detected in AST, DBIL. These outliers were excluded from further

Discussion

Liver and kidney function tests are commonly applied in routine clinical evaluation, diagnosis, treatment, and prognosis. ALT, BUN, and Cre levels in children and adolescents are quite different from those of healthy adults [11]. In addition, reference intervals of children and adolescents are in a non-fixed range because their eating habits and physiological development may have an impact on the reference intervals [12]. Therefore, it is necessary to establish suitable reference intervals for

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