两种免疫分析系统对甲状腺过氧化物酶抗体的一致性评价  

A Consistency Evaluation of Two Chemiluminescence ImmunoassaySystems for Thyroid Peroxidase Antibody

作　　者：李文贤 解朋[2] 于志暄 王煜 LI Wenxian;XIE Peng;YU Zhixuan;WANG Yu(Department of Endocrinology,Zhangjiakou First Hospital,Zhangjiakou 075000,China;Department of Nuclear Medicine,the Third Hospital,Hebei Medical University,Shijiazhuang 050051,China;The Second Department of Internal Medicine,Huailai County Hospital,Zhangjiakou 075400,China;Department of Nuclear Medicine,Zhangjiakou First Hospital,Zhangjiakou 075000,China)

机构地区：[1]张家口市第一医院内分泌科,河北张家口075000 [2]河北医科大学第三医院核医学科,河北石家庄050051 [3]张家口市怀来县医院内二科,河北张家口075400 [4]张家口市第一医院核医学科,河北张家口075000

出　　处：《标记免疫分析与临床》2022年第3期492-495,510,共5页Labeled Immunoassays and Clinical Medicine

基　　金：河北省医学科学研究课题(编号:20221197)。

摘　　要：目的评估国产和进口两种化学发光法免疫分析系统检测血清甲状腺过氧化物酶抗体(TPOAb)结果的一致性,探讨国产化学发光法免疫分析系统(MAGLUMI 4000PLUS全自动化学发光法免疫分析系统)检测TPOAb的可行性和实用性。方法用两种方法检测130份血清样本TPOAb水平,比较两种检测方法的相关性、符合率,并对国产化学发光法检测TPOAb的精密度、正确度、线性范围及参考区间进行验证。结果国产化学发光法免疫分析系统检测TPOAb的批内精密度均小于1/4 Tea,批间精密度均小于1/3 Tea。TPOAb在两个水平上的偏倚分别为-1.86和0.25,均在1/2 Tea(12.5%)内,正确度的能力验证成绩为100%。线性验证显示,TPOAb的斜率为0.988,线性良好。20例健康者检测值100%在生物参考区间内。国产和进口两种化学发光法免疫分析系统检测TPOAb在数值上存在统计学差异(Z=-8.395,P<0.05),但两种方法整体相关性良好(r=0.802,P<0.05);两种方法检测TPOAb总体一致性较好,Kappa分析值为0.937,总符合率为97.69%,定性分类差异无统计学意义。结论国产化学发光法免疫分析系统检测TPOAb的精密度、正确度、线性范围、生物参考区间均符合检测要求;与进口化学发光法免疫分析系统相关性和一致性良好。国产化学发光法免疫分析系统测定TPOAb能够满足临床需求。Objective To evaluate the consistency of serum thyroid peroxidase antibody(TPOAb)detected by domestic and imported chemiluminescence immunoassay systems,and to explore the feasibility and practicability of domestic chemiluminescence immunoassay system(MAGLUMI 4000PLUS automatic chemiluminescence immunoassay system)in detecting TPOAb.Methods TPOAb of 130 samples were detected by the above two methods.The correlation,positive and negative coincidence rate of the two methods were compared,and the precision,accuracy,linear range and reference interval of the new domestic chemiluminescence method were verified.Results The intra assay precision and inter assay precision of domestic chemiluminescence immunoassay system for TPOAb were less than 1/4tea and 1/3tea,respectively.The bias of TPOAb at two levels was-1.86 and 0.25,respectively,both within 1/2tea(12.5%).The accuracy of the ability verification was 100%.The linear verification showed that the slope of TPOAb was 0.988,therefore,the linearity was good.The detection TPOAb value of 20 healthy people was 100%in the biological reference range.There were significant differences in TPOAb values between domestic and imported chemiluminescence immunoassay systems(Z=-8.395,P<0.05),however,the overall correlation between the two methods was good(r=0.802,P<0.05).The overall consistency of TPOAb detected by the two methods was satisfactory,Kappa analysis value was 0.937 and total coincidence rate was 97.69%.Conclusion The precision,accuracy,linear range and biological reference interval of domestic chemiluminescence immunoassay system for TPOAb detection coincide with the detection requirements.The correlation and consistency with the imported chemiluminescence immunoassay system are satisfactory.Our results show that the domestic chemiluminescence immunoassay system can be applicable.

关 键 词：甲状腺 甲状腺过氧化物酶抗体 一致性评价 

分 类 号：R581.4[医药卫生—内分泌]