CA72-4、CA19-9、CA242实验室参考区间的建立  

Establishment of Laboratory Reference Interval for CA72-4,CA19-9,CA242

作　　者：李国立 成荣 陈保德[4] LI Guoli;CHENG Rong;CHEN Baode(Zhejiang University School of Medicine,Hangzhou 310058,China;Department of Clinical Laboratory,Ningbo Daxie Development zone Hospital,Ningbo,315812,China;The Laboratory Department of the 251 ST Hospital of PLA,Zhangjiakou 07500;The Laboratory Department of the First Affiliated Hospital of Medical School of Zhejiang University,Hangzhou 310003,China)

机构地区：[1]浙江大学医学院,杭州310058 [2]宁波大榭开发区医院检验科,宁波315812 [3]中国人民解放军第251医院检验科,张家口075000 [4]浙江大学医学院附属第一医院检验科,杭州310003

出　　处：《国际检验医学杂志》2017年第A02期100-104,共5页International Journal of Laboratory Medicine

摘　　要：目的建立适用于本实验室的肿瘤相关抗原CA72-4、CA19-9、CA242生物参考区间。方法严格按照ISO15189:(CNAS-CL02-2012)《医学实验室质量和能力认可准则》条款和临床实验室标准化协会(CLSI)C28-A3文件CLSI文件C28-A3《医学实验室参考区间的定义、建立和确认》推荐方法要求,收集1609例健康体检人群血清样本并对CA72-4、CA19-9、CA242进行测定,取2.5%到97.5%的百分位点所在的区间作为95%参考区间,建立适用于本实验室的生物参考区间。结果CA72-4、CA19-9、CA242在不同性别组间均有统计学差异(P<0.05),应按性别不同建立参考区间;同时CA19-9、CA242在女性不同年龄组间有统计学差异(P<0.05),而在男性不同年龄组间无统计学差异,因此女性组中应按不同年龄段建立CA19-9、CA242的参考区间。CA72-4在男女不同年龄组均无统计学差异,无需按年龄分组建立参考区间。结论我们建立了CA72-4、CA19-9、CA242的本实验室参考区间,为参考区间的规范提供了新的思路,为以后本实验室乃至全国各地区建立参考区间提供了模板和依据。Objective To establish a bio-reference range for tumor related antigen CA72-4,CA19-9,CA242.Methods According to the requirements of ISO15189:(CNAS-CL02-2012)"Medical Laboratory-Special Requirements for Quality and Ability",and the recommended method of Clinical and Laboratory Standards Institute(CLSI)C28-A3,we collected1609reference cases to measure CA72-4,CA19-9,CA242values and built the biological reference interval of the tumor related markers from2.5%to97.5%as the95%reference range.Results The reference intervals of CA242,CA19-9were built according to gender and age,meanwhile,CA72-4reference interval was built according to gender.Conclusion The reference intervals of CA72-4,CA19-9and CA242have be established for our laboratory,which provides a new idea for the reference interval specification,as well as it provides a template and basis for establishing reference interval in our laboratory and even throughout the country.

关 键 词：肿瘤相关抗原 消化道肿瘤 实验室生物参考区间 

分 类 号：R735.04[医药卫生—肿瘤]