全自动血小板功能分析仪性能验证研究  

Study on the performance verification on CS-100 full-automatic PLT function analyzer

作　　者：郭盼[1] 温雪[1] 徐佳[1] 宋振宝 张鹏[1] 孙合乐 李琦[1] GUO Pan;WEN Xue;XU Jia(Department of Laboratory,Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences,Beijing 100091,China;不详)

机构地区：[1]中国中医科学院西苑医院检验科,北京100091

出　　处：《中国医学装备》2022年第5期44-47,共4页China Medical Equipment

摘　　要：目的:分析评价CS-100全自动血小板功能分析仪的性能指标,验证CS-100全自动血小板功能分析仪的性能。方法:收集医院住院及门诊就诊患者10份新鲜全血样本从精密度、准确性、线性、携带污染率及血小板(PLT)最大聚集率5项性能指标对CS-100全自动血小板功能分析仪的性能进行全面评价。结果:CS-100全自动血小板功能分析仪PLT计数、红细胞(RBC)计数、批内精密度、批间精密度及准确性均满足国家医药行业标准《YY/T0653-2008血液分析仪》要求(PLT变异系数(CV)≤8%,RBC变异系数(CV)≤2%;PLT偏倚≤8%,RBC偏倚≤2.5%),PLT和RBC与理论值的相关系数R^(2)值分别为0.9986和0.9989,PLT和RBC的线性误差均在实验要求范围内(PLT≤±10.0%;RBC≤±5.0%)。10个样本双份检测结果的极差均≤10%。PLT携带污染率为1.6%,RBC携带污染率为1.6%,符合要求(PLT≤5%;RBC≤2%)。结论:CS-100全自动血小板分析仪5项性能指标经验证后均符合要求,可应用于临床检测。Objective:To analyze and evaluate the performance indexes of CS-100 full-automatic platelet(PLT)function analyzer and verify the performance of CS-100 full-automatic PLT function analyzer.Methods:Ten whole blood samples of patients who were in hospital and admitted to outpatient were collected to conduct comprehensive evaluation for the performance of CS-100 full-automatic PLT function analyzer from five performance indexes including precision,accuracy,linearity,carry over rate and maximum aggregation rate of PLT.Results:Both withinbatch precision,between-batch precision and accuracy of PLT count and red blood cell(RBC)count of CS-100 fullautomatic PLT function analyzer met the requirements of《YY/T0653-2008 Hematology Analyzer》of national pharmaceutical industry standard[Coefficient of variation(CV)of PLT≤8%,RBC CV≤2%,PLT bias≤8%,RBC bias≤2.5%],and the correlation coefficients(R^(2))between PLT values and theoretical values,and between RBC values and theoretical values were 0.9986 and 0.9989,respectively.And the linear errors both PLT and RBC were within the range of experimental requirements(PLT≤+10.0%,RBC≤5.0%).The range difference of double test results of 10 samples was≤10%.The carry over rate of PLT was 1.6%,and that of RBC was 1.6%,and all of them met the requirements(PLT≤5%,RBC≤2%).Conclusion:The five performance indexes of CS-100 full-automatic PLT analyzer can meet the requirements after verification,and that can be applied in clinical test of our laboratory.

关 键 词：血小板功能分析仪 性能验证 质量控制 

分 类 号：R197.39[医药卫生—卫生事业管理]