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Licensed Unlicensed Requires Authentication Published by De Gruyter August 8, 2022

Reference intervals of 14 biochemical markers for children and adolescence in China: the PRINCE study

  • Xiaoxia Peng ORCID logo , Yaguang Peng , Chuanbao Zhang ORCID logo , Min Zhao , Hongling Yang , Sancheng Cao , Guixia Li , Yongmei Jiang , Zhenxin Guo , Dapeng Chen , Jin Xu , Hongbing Chen , Yun Xiang , Runqing Mu , Jie Zeng , Ying Shen , Yan Wang , Qiliang Li , Lixin Hu , Na Ren , Yanying Cai , Wei Zhang , Jie Ma , Ruohua Yan , Wenxiang Chen EMAIL logo , Wenqi Song EMAIL logo , Xin Ni EMAIL logo and on behalf of The Study Group of Pediatric Reference Intervals in China (PRINCE)

Abstract

Objectives

The Pediatric Reference Intervals in China (PRINCE) was initiated to establish the reference intervals (RIs) of Chinese children, as well as to make it possible to compare the variability of biochemical markers among countries internationally.

Methods

Healthy participants, aged up to 20 years, from 11 provinces across China, were enrolled in PRINCE and according to a standard screening procedure, that included a questionnaire survey, physical examinations and laboratory tests. Fasting venous blood specimens were collected. All serum specimens were analyzed with Cobas C702 in the center laboratory, i.e. clinical laboratory of Beijing Children’s Hospital, with certified qualification (ISO15189). The nonparametric method recommended by Clinical Laboratory Standards Institute guidelines, was used to calculate the age- and sex-specified RIs.

Results

Among the 15,150 participants enrolled, 12,352 children (6,093 males and 6,259 females) were included to calculate RIs. The RIs for total protein, albumin, globulin, calcium, phosphate, potassium, sodium, chlorine, alkaline phosphatase, γ-glutamyl transpeptadase, alanine aminotransferase, aspartate aminotransferase, creatinine and urea were established by age- or sex-partitions. Most biochemical markers displayed larger variability and higher dispersion during the periods between 28 days and 1 year old, and included 4–6 age partitions commonly during 1 to <20 years old. In addition, differences of RIs between sexes usually occurs around the initiation of puberty at 12–13 years old.

Conclusions

The age- and sex-specified RIs of 14 biochemical markers in PRINCE study can provide a solid reference, which will be transferred into relevant RIs for other clinical laboratory’s platforms according to the CLSI guidelines.


Corresponding authors: Wenxiang Chen, National Center for Clinical Laboratories, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, No. 1 Dahua Road, Beijing, 100730, P.R. China, Phone: +86-010-58115060, E-mail: ; Wenqi Song, Department for Clinical Laboratory Center, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, No.56 Nanlishi Road, Beijing, 100045, P.R. China, Phone: +86-010-59616962, E-mail: ; and Xin Ni, Beijing Key Laboratory for Pediatric Diseases of Otolaryngology, Head and Neck Surgery, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, No. 56 Nanlishi Road, Beijing, 100045, P.R. China, Phone: +86-010-59616688, E-mail:
Xiaoxia Peng, Yaguang Peng, Chuanbao Zhang, Min Zhao, Hongling Yang, Sancheng Cao, Guixia Li, Yongmei Jiang, Zhenxin Guo, Dapeng Chen, Jin Xu, Hongbing Chen, and Yun Xiang are contributed equally to this work.

Funding source: National Health Commission of the People’s Republic of China

Award Identifier / Grant number: 2017374

Acknowledgments

We thank the staff members of the PRINCE study team. Special thanks is also due to all participants for their involvement, as well as their parents for their supports during the study. We would also like to that Dr. Ali Abbas for editing the manuscripts’ language.

  1. Research funding: The grand from Medical hospital authority, National Health Commission of the People’s Republic of China (No. 2017374).

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. PX, PY, ZC, ZM, YH, CS, LG, JY, GZ, CD, XJ, CH, and XY were contributed equally for writing the manuscript, as well as the organization and implementation of the study in each center, including epidemiological investigation, physical examination, specimen collection and transfer. MR, ZJ, SY, WY, LQ, HL, RN, CY, ZW, MJ were contributed the specimen management, laboratory test and quality control. YR, PX, and PY were in charge of the epidemiological methodology design, data management and data analysis. CW, SW, and NX were contributed equally for conceive the study.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from each participant’s legally authorized representative (parent or guardian) in the case of children aged less than 8 years. Otherwise, the informed consent was obtained from both the child and their legally authorized representative.

  5. Ethical approval: The PRINCE study was approved by The Institutional Review Board of Beijing Children’s Hospital (IEC-C-028-A10-V.05).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0299).


Received: 2022-03-28
Accepted: 2022-07-13
Published Online: 2022-08-08
Published in Print: 2022-09-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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