ADVIA Centaur XP全自动化学发光免疫分析系统的性能验证及评价  

Performance test and evaluation of ADVIA Centaur XP automatic chemiluminescence immunoassay system

作　　者：张玥[1] 董振芳[1] 鞠瑛[1] 刘义庆[1] 王勇[1] 张炳昌[1] ZHANG Yue;DONG Zhenfang;JU Ying;LIU Yiqing;WANG Yong;ZHANG Bingchang(Department of Clinical Laboratory,Shandong Provincial Hospital Affiliated to Shandong University,Jinan,Shandong 250021,China)

机构地区：[1]山东大学附属省立医院临床医学检验部,济南250021

出　　处：《国际检验医学杂志》2018年第3期289-292,共4页International Journal of Laboratory Medicine

基　　金：国家自然科学基金资助项目(81000731);山东省自然科学基金(ZR2016HM52)

摘　　要：目的对ADVIA Centaur XP全自动化学发光免疫分析系统检测甲状腺激素和抗体的性能指标进行验证及评价。方法参照美国临床实验室标准化协会指南等相关文件,对三碘甲状腺原氨酸(T3)、四碘甲状腺原氨酸(T4)、游离三碘甲状腺原氨酸(FT3)、游离甲状腺素(FT4)、促甲状腺素(TSH)、甲状腺球蛋白抗体(抗-TG)、甲状腺过氧化物酶抗体(抗-TPO)共7项甲状腺激素和抗体项目的精密度、准确度、线性范围和携带污染率进行验证。结果检测的7项甲状腺激素和抗体批内精密度变异系数(CV)和批间精密度CV分别在1.51%~6.17%和1.86%~7.27%之间。准确度平均偏倚最大的检测项目是FT3(8.47%),但在可接受范围内,相关性良好,相关系数r≥0.994,平均偏倚均<1/2CLIA′88允许总误差[TEa(12.5%)]。T3,T4,FT3,FT4,TSH,抗-TG和抗-TPO分别在1.24~5.59nmol/L、60.07~195.10nmol/L、3.40~22.87pmol/L、14.59~40.54pmol/L、1.63~74.13μIU/mL、60.10~381.30μIU/mL和180.10~531.50μIU/mL范围内呈线性。携带污染率在0.04%~0.97%之间。结论 ADVIA Centaur XP全自动化学发光免疫分析系统检测甲状腺激素和抗体的结果与厂家所提供的数据相符,检测结果准确可靠,可用于临床样本的检测。Objective The ADVIA Centaur XP automatic chemiluminescence immunoassay system detection performance of the thyroid hormones and antibodies for validation and evaluation.Methods With reference to the American association of clinical laboratory standardization guide and other related documents,the ADVIA Centaur XP automatic chemiluminescence immunoassay system test 7 items thyroid hormones and antibodies(T 3,T 4,FT 3,FT 4,TSH,anti-TG,anti-TPO)of precision,accuracy,linear range and carry pollution rate for validation.Results Within the seven thyroid hormones and antibodies batch testing precision of CV and CV between batch precision between 1.51%-6.17%and 1.86%-6.17%.Is the average accuracy of bias of the largest testing project FT 3(8.47%),but in the acceptable range,good correlation,correlation coefficient R of 0.994 or higher,Average bias<1/2 CLIA′88 TEa(12.5%).T 3,T 4,FT 3,FT 4,TSH,anti-TG and anti-TPO in 1.24-5.59 nmol/L respectively,and 60.07-195.10 nmol/L,3.40-22.87 pmol/L,14.59-40.54 pmol/L,1.63-74.13μIU/mL,60.10-381.30μIU/mL and 180.10-531.50μIU/mL range is linear,Carry pollution rate is between 0.04%-0.97%.Conclusion ADVIA Centaur XP automatic chemiluminescence immunoassay system detecting thyroid hormones and antibodies results consistent with the data provided by the manufacturer,the test results are accurate and reliable,and can be used for the detection of clinical samples.

关 键 词：化学发光仪 性能验证 甲状腺激素 

分 类 号：R446.1[医药卫生—诊断学]