基于CLSI EP9-A3的血清人绒毛膜促性腺激素β亚单位方法学比对及偏移评估  

Methodological comparison and migration assessment of human chorionic gonadotropin in serum based on CLSI EP9-A3

作　　者：傅金可 赵华 陈亚芳 FU Jin-ke;ZHAO Hua;CHEN Ya-fang(Clinical Laboratory,Shaoxing Central Hospital,Shaoxing,Zhejiang 312030,China)

机构地区：[1]绍兴市中心医院检验科,浙江绍兴312030 [2]桐庐县第一人民医院检验科,浙江桐庐311500

出　　处：《中国卫生检验杂志》2020年第11期1352-1355,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的分析不同检测系统间血清人绒毛膜促性腺激素β亚单位(β-HCG)检测结果的可比性。方法分别用贝克曼DXI 800检测系统(参比系统x)与星童Pylon 3D检测系统(待测系统y)测定β-HCG。参照美国临床和实验室标准化协会(CLSI) EP9-A3文件进行方法学比对和偏移评估,通过广义极端学生化偏差(ESD)法检验离群值点,选用最佳回归模型拟合回归方程,并计算医学决定水平处的偏移,以1/2澳大利亚室间质评的评价标准作为可接受标准。结果广义ESD法检验发现1个离群值点,剔除再补充1个数据后,无离群值。通过Passing-Bablok回归分析得回归方程:y=-2. 000+1. 000x。根据Passing-Bablok回归方程估算β-HCG在各医学决定水平处(5 IU/L、25 IU/L、500 IU/L、1 000 IU/L)的偏移结果,偏移均小于可接受标准。结论星童Pylon 3D检测系统与贝克曼DXI 800检测系统之间血清总β-HCG的检测结果具有可比性。Objective To compare the results of human chorionic gonadotropin beta subunits( β-HCG) between different detection systems. Methods The β-HCG was determined by the Beckman DXI 800 detection system( reference system x)and the ET Healthcare Pylon 3 D detection system( system y). With reference to the CLSI EP 9-A3 document for methodological comparison and offset assessment,the out-of-group value point was tested by the generalized extreme studentized deviate( ESD) method,and the best regression model was used to fit the regression equation. And the deviation at the level of medical determination was calculated,taking 1/2 of the evaluation criteria of the Australian inter-room quality assessment as an acceptable standard. Results The generalized ESD method found that there was one outlier value point,and after adding another data,there was no outlier value. The regression equation was obtained by Passing-Bablok regression analysis: y =-2. 000 +1. 000 x. The offset results of β-HCG at each medical determination level( 5 IU/L,25 IU/L,500 IU/L,1 000 IU/L) were estimated based on the Passing-Bablok regression equation, and the offset was less than the acceptable standard.Conclusion The detection results of serum total β-HCG between the Beckman DXI 800 detection system and the ET Healthcare Pylon 3 D detection system are comparable.

关 键 词：化学发光 人绒毛膜促性腺激素Β亚单位 方法学比对 

分 类 号：R446.6[医药卫生—诊断学]