Sysmex HISCL-800全自动化学发光免疫分析仪检测血栓分子标志物的性能评价与分析  

A Performance Evaluation and Related Analysis of Sysmex HISCL-800 Automatic Chemiluminescence Immunoanalyzer for DetectingMolecular Markers of Thrombus

作　　者：赖媛媛 李碧君 陆秋霞 齐军 张佳玲 杨微 LAI Yuanyuan;LI Bijun;LU Qiuxia;QI Jun;ZHANG Jialing;YANG Wei(National Cancer Center/National Clinical Research Center for Cancer/Deparment of Clinical Laboratory,Cancer Hospital&Shenzhen Hospital,Chinese Academy of Medical Sciences andPeking Union Medical College,Shenzhen 518116,China)

机构地区：[1]国家癌症中心,国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院深圳医院检验科,广东深圳518116

出　　处：《标记免疫分析与临床》2023年第11期1926-1929,共4页Labeled Immunoassays and Clinical Medicine

基　　金：深圳市医疗卫生三名工程项目(编号:SZSM201812062);深圳市高水平医院建设专项经费。

摘　　要：目的应用CLSI评价方案对Sysmex HISCL-800全自动化学发光免疫分析仪检测血栓分子标志物项目进行性能验证。方法根据CLSI系列文件(EP15-A、EP6-A),对Sysmex HISCL-800全自动化学发光免疫分析仪检测系统的血栓分子标志物项目的精密度、线性、参考区间、正确度进行评价与分析,结果与厂商声明的性能进行比较。结果血栓分子标志物4个检测项的实验室内变异系数结果均小于厂家声明的批内变异系数(CV<10%)。且该4项的线性回归方程的斜率均在1.00±0.05范围内,相关系数均R^(2)≥0.99。它们的参考区间验证结果均有95%以上检测值在参考范围内。该4项正确度均通过验证。结论Sysmex HISCL-800全自动化学发光免疫分析仪检测血栓分子标志物项目的实验结果与厂商声明的性能基本符合质量目标要求。Objective The performance of the Sysmex HISCL-800 automatic chemiluminescence immunoanalyzer for thrombus detection was verified using CLSI evaluation protocol.Methods We evaluated and analyzed the items of the precision,linearity,reportable range,reference interval and correctness of the molecular markers of the Sysmex HISCL-800 Chemiluminescence in the CLSI series(EP15-A,EP6-A).The precision,linearity,reference interval and correctness of the Sysmex HISCL-800 Automatic Chemiluminescence immunoanalyzer detection system were evaluated,and the results were compared with the performance declared by the manufacturer.Results The results of the laboratory coefficient of variation of the four tests of thrombus molecular markers were less than the batch coefficient of variation declared by the manufacturer(CV<10%).Furthermore,the slope of the linear regression equation of these four terms was within 1.00±0.05,and the correlation coefficients were all R^(2)≥0.99.Their reference interval validation results had more than 95%of the detection values within the reference range.All four correctness were verified.Conclusion The experimental results of Sysmex HISCL-800 automatic chemiluminescence immunoanalyzer generally meet the requirements of the manufacturer.

关 键 词：Sysmex HISCL-800全自动化学发光免疫分析仪 凝血酶-抗凝血酶复合物 纤溶酶-α^(2)-纤溶酶抑制剂复合物 血栓调节蛋白 组织纤溶酶原激活物-纤溶酶原激活物抑制剂-1复合蛋白 性能评价 

分 类 号：R446[医药卫生—诊断学]