LiCA500全自动化学发光仪检测甲状腺项目的性能验证

The Clinical Performance of LiCA500 Automatic Photoluminescence Immunoanalyzer for Thyroid Examination

目的对LiCA500全自动光激化学发光免疫分析系统及配套甲状腺项目检测试剂盒(化学发光法)进行临床分析性能验证。方法依据国家卫生行业标准(WS/T492-2016)和美国临床实验室标准化协会(CLSI)EP系列文件的要求,对LiCA500全自动光激化学发光免疫分析系统检测抗甲状腺过氧化物酶抗体(thyroid peroxidase antibody,TPOAb)、抗甲状腺球蛋白抗体(thyroglobulin antibody,TGAb)和甲状腺球蛋白(thyroglobulin,TG)的精密度、准确度、线性范围和参考区间进行验证,并与厂商声明的性能标准进行比较。对40份血清进行检测,并与传统的放射免疫法检测结果进行比对。结果LiCA500全自动光激化学发光免疫分析系统检测TPOAb、TGAb和TG的批内不精密度变异系数(CV)均≤8%,总不精密度均≤1/3 TEa;校准品检测均值与靶值的偏倚均≤1/2 TEa;线性回归方程斜率在0.992~1.010之间,R^(2)均≥0.975;正常人血清样本的检测结果均在参考区间内;与放射免疫法检测结果进行线性回归分析,R^(2)均≥0.95。结论LiCA500全自动光激化学发光免疫分析仪检测TPOAb、TGAb和TG的分析性能符合要求,可用于临床上甲状腺疾病的诊断。

Objective LiCA500 automatic photoluminescence immunoassay system and supporting reagent(chemiluminescence method)for thyroid detection were verified for its clinical analysis performance.Methods According to the requirements of National Health Care Industry Standard(WS/T492-2016)and Clinical and Laboratory Standards Institute(CLSI)EP series documents,the levels of thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TGAb)and thyroglobulin(TG)were validated by LiCA500 automatic photoluminescence immunoanalyzer to assess the precision,accuracy,linearity,and biotic reference interval,and compared with manufacturer’s stated performance standards.Forty serum samples were examined and compared with the results of conventional radioimmunoassay.Results The within-run precision of TPOAb,TGAb and TG were≤8%and the total precision were≤1/3TEa.Bias of work standards mean and target values were≤1/2TEa.The linear regression coefficient range was between 0.992 and 1.010(R^(2)≥0.975).All individual results were in the range of biotic reference interval.The results of methodological comparison with radioimmunoassay were analyzed by linear regression with R^(2)≥0.95.Conclusion The analytical performances of TPOAb,TGAb and TG detected by LiCA500 automatic photoluminescence immunoanalyzer meet the expected requirements,which can be used for the clinical diagnosis of thyroid diseases.