应用医院存储数据建立血清Cyfra21-1、SCCA、CEA参考区间  

Establishment of Cyfra21-1,SCCA and CEA reference intervals from hospital-stored data

作　　者：李小佩[1] 王惠民[1,2] 王建新[1] 陶赟[1] 季伙燕[1] 

机构地区：[1]南通大学附属医院检验医学中心,江苏南通226001 [2]南通大学检验医学研究所,江苏南通226001

出　　处：《临床检验杂志》2015年第12期946-949,共4页Chinese Journal of Clinical Laboratory Science

基　　金：南通市科技项目(HS2012009);国家质检总局公益性行业科研专项经费项目(201210066)

摘　　要：目的应用医院存储数据建立血清细胞角蛋白19片段（Cyfra21-1）、鳞状细胞癌抗原（SCCA）、癌胚抗原（CEA）间接参考区间。方法收集2014年4月至2015年3月南通大学附属医院实验室信息系统（LIS）存储的所有Cyfra21-1、SCCA、CEA检测值,经数据筛选、线性拟合,建立其间接参考区间。选取2015年1-3月南通大学附属医院体检健康者454例,按照美国临床和实验室标准化协会（CLSI）文件C28-A3要求,采用非参数方法建立上述项目参考区间。结果存储数据组Cyfra21-1、SCCA、CEA间接参考区间为0-2.87 ng/m L、0-1.76 ng/m L、0-3.77 ng/m L,健康组数据建立的Cyfra21-1、SCCA、CEA间接参考区间为0-2.84 ng/m L、0-1.38ng/m L、0-3.60 ng/m L。结论存储数据建立检验项目的生物参考区间省时、省力,可用于实验室现有参考区间的验证。Objective To establish the indirect reference intervals for serum cytokeratin 19 fragment（Cyfra21-1 ）, squamous cell carcinoma antigen（SCCA） and carcinoembryonic antigen（CEA） from hospital-stored data. Methods All the test resuhs of serum Cyfra21-1, SCCA and CEA stored in the laboratory information system（LIS） of the Affiliated Hospital of Nantong University during April 2014 to March 2015 were collected, screened and linearly fitted to establish the indirect reference intervals. Meanwhile, a total of 454 subjects who performed medical examination in the Affiliated Hospital of Nantong University during January 2015 to March 2015 were enrolled, and the serum Cyfra21-1, SCCA and CEA reference intervals were established with non-parametric methodology recommended by CLSI C28-A3. Results The indirect reference intervals for serum Cyfra21-1, SCCA and CEA based on hospital-stored data were 0 - 2.87 ng/mL, 0 - 1.76 ng/mL and 0 - 3.77 ng/mL, while those based on the healthy subjects were 0 - 2.84 ng/mL, 0 - 1.38 ng/mL and 0 - 3.60 ug/mL. Conclusion The establishment of indirect reference intervals based on hospital-stored data may save time and labor, which may be used to verify the current reference intervals in laboratories.

关 键 词：参考区间 细胞角蛋白19片段 鳞状细胞癌抗原 癌胚抗原 

分 类 号：R446.1[医药卫生—诊断学]