[A multicenter study of reference intervals for 15 laboratory parameters in Chinese children]
1Department of Pediatrics, Peking University First Hospital, Beijing 100034, China.
Insights
This study established crucial age- and sex-specific laboratory reference intervals for 15 clinical parameters in healthy Chinese children. These findings provide essential benchmarks for pediatric health assessment and diagnosis.
Area of Science:
- Clinical Biochemistry
- Pediatric Laboratory Medicine
- Reference Interval Establishment
Background:
- Accurate laboratory reference intervals are vital for diagnosing diseases in children.
- Existing reference intervals may not be applicable to the diverse Chinese pediatric population.
- Need for comprehensive, age- and sex-stratified data for 15 key clinical laboratory parameters.
Purpose of the Study:
- To establish comprehensive, age- and sex-specific laboratory reference intervals for Chinese children.
- To provide reliable benchmarks for interpreting clinical laboratory results in pediatric populations.
Main Methods:
- Cross-sectional, multicenter study involving 1,648 healthy children aged 6 months to 17 years.
- Physical examination, questionnaire, and abdominal ultrasound used for eligibility assessment.
- Analysis of 15 clinical laboratory parameters including hormones, liver enzymes, renal function markers, immunoglobulins, and complements.
Main Results:
- Established age- and sex-specific reference intervals for 15 clinical laboratory parameters.
- Observed age-related increases in sex hormones and significant changes in ALT, cystatin C, ALP, and CK in younger children.
- Noted rapid adolescent increases in sex hormones, creatinine, immunoglobulins, CK, and urea, with distinct sex differences.
Conclusions:
- Successfully established age- and sex-specific reference intervals for 15 clinical laboratory parameters in a cohort of healthy Chinese children.
- Highlights the variability of reference intervals based on age, sex, and assay methodologies.
- Provides essential data for accurate clinical laboratory interpretation in Chinese pediatric healthcare.
Abstract:
Objective: To establish comprehensive laboratory reference intervals for Chinese children. Methods: This was a cross-sectional multicenter study. From June 2013 to December 2014, eligible healthy children aged from 6-month to 17-year were enrolled from 20 medical centers with informed consent. They were assessed by physical examination, questionnaire survey and abdominal ultrasound for eligibility. Fasting blood samples were collected and delivered to central laboratory. Measurements of 15 clinical laboratory parameters were performed, including estradiol (E2), testosterone(T), luteinizing hormone(LH), follicle-stimulating hormone(FSH), alanine transaminase(ALT), serum creatinine(Scr), cystatin C, immunoglobulin A(IgA), immunoglobulin G(IgG), immunoglobulin M(IgM), complement (C3, C4), alkaline phosphatase(ALP), uric acid(UA) and creatine kinase(CK). Reference intervals were established according to central 95% confidence intervals for reference population, stratified by age and sex. Results: In total, 2 259 children were enrolled. Finally, 1 648 children were eligible for this study, including 830 boys and 818 girls, at a mean age of 7.4 years. Age- and sex- specific reference intervals have been established for the parameters. Reference intervals of sex hormones increased gradually with age. Concentrations of ALT, cystatin C, ALP and CK were higher in children under 2 years old. Serum levels of sex hormones, creatinine, immunoglobin, CK, ALP and urea increased rapidly in adolescence, with significant sex difference. In addition, reference intervals were variable depending on assay methods. Concentrations of ALT detected by reagents with pyridoxal 5'-phosphate(PLP) were higher than those detected by reagents without PLP. Compared with enzymatic method, Jaffe assay always got higher results of serum creatinine, especially in children younger than 9 years old. Conclusion: This study established age- and sex- specific reference intervals, for 15 clinical laboratory parameters based on defined healthy children.
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