检验医学 ›› 2020, Vol. 35 ›› Issue (7): 676-681.DOI: 10.3969/j.issn.1673-8640.2020.07.011

• 临床应用研究·论著 • 上一篇    下一篇

我国儿童常规化学项目参考区间现状调查及结果分析

杜雨轩, 王薇, 何法霖, 钟堃, 袁帅, 刘佳丽, 张志新, 王治国()   

  1. 北京医院 国家老年医学中心 国家卫生健康委临床检验中心 中国医学科学院老年医学研究院,北京 100730
  • 收稿日期:2019-11-14 出版日期:2020-07-30 发布日期:2020-08-04
  • 作者简介:null

    作者简介:杜雨轩,女,1988年生,博士,助理研究员,主要从事临床实验室管理研究。

Investigation and analysis on pediatric reference intervals of routine chemistry items in China

DU Yuxuan, WANG Wei, HE Falin, ZHONG Kun, YUAN Shuai, LIU Jiali, ZHANG Zhixin, WANG Zhiguo()   

  1. National Center for Clinical Laboratories,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China
  • Received:2019-11-14 Online:2020-07-30 Published:2020-08-04

摘要:

目的 对儿童13个常规化学项目参考区间的来源及上限、下限的差异进行分析。方法 向参加国家卫生健康委临床检验中心室间质量评价(EQA)的395家医疗机构临床实验室发放儿童13个常规化学项目参考区间信息调查表,各实验室按规定格式上报目前使用的参考区间、测定方法、仪器和试剂等相关信息。结果 395家实验室中有122家(30.9%)回报了参考区间。13个常规化学项目的参考区间主要来源于《全国临床检验操作规程》和试剂说明书(63.0%~69.3%)。有44.5%~50.0%的实验室对参考区间进行了验证。仅有少部分实验室按年龄、性别对参考区间进行了分层。尿素(Urea)、肌酐(Cr)、天门冬氨酸氨基转移酶(AST)和γ-谷氨酰基转移酶(GGT)参考区间的上、下限及丙氨酸氨基转移酶(ALT)参考区间的下限不同性别之间差异均有统计学意义(P<0.05)。约有35.0%的实验室按年龄和/或性别对碱性磷酸酶(ALP)参考区间进行分层,按性别分层的上限和上、下限差值差异均有统计学意义(P<0.01、P<0.05);按年龄分层比较,<1岁、1~12岁、13~15岁和>15岁各年龄组之间的参考区间上、下限及差值差异均有统计学意义(P<0.05),而各年龄组内比较差异无统计学意义(P>0.05)。结论 我国儿童常规化学项目参考区间现状并不乐观,应针对儿童性别及成长过程中的不同阶段建立合适的儿童检验项目参考区间。

关键词: 参考区间, 常规化学项目, 儿童

Abstract:

Objective To investigate the lower and upper limit difference of pediatric reference intervals of 13 routine chemistry items. Methods The questionnaires on reference intervals of 13 routine chemistry items were distributed to 359 clinical laboratories participating the external quality assessment(EQA) program of the National Center for Clinical Laboratories. The participating clinical laboratories reported reference intervals,methods,instruments and reagents used in prescribed form. Results The number of clinical laboratories participating in routine chemistry reference intervals was 122(30.9%). The primary source of reference intervals were from National Guide on Clinical Laboratory Procedures and instructions of instrument and reagent manufactures(63.0%-69.3%). Totally,44.5%-50.0% of participants had the verified reference intervals. Only a few clinical laboratories had considered different ages and sex when establishing reference intervals. There was statistical significance for lower and upper limits of urea(Urea),creatinine(Cr),aspartate aminotransferase(AST),gamma-glutamyltransferase(GGT) and lower limit of alanine aminotransferase(ALT)(P<0.05). A total of 35.0% of participants had considered different ages and sex in alkaline phosphatase(ALP)(P<0.01,P<0.05),and there was statistical significance for its lower and upper limits for <1-year-old,1-12-year-old,13-15-year-old and >15-year-old children(P<0.05),and there was no statistical significance in the age intra-group(P>0.05). Conclusions The status of pediatric reference intervals of routine chemistry among clinical laboratories in China is not good. It is required to establish the pediatric reference intervals in China according to different ages and sex.

Key words: Reference interval, Routine chemistry, Children

中图分类号: