XE-2100D血细胞分析仪的性能验证  

Performance Verification of XE-2100D Blood Cell Analyzer

作　　者：裴银桃 沙伟 Pei Yintao;Sha Wei(Corresponding Author）（Laboratory Medicine Center,The Second Affiliated Hospital of Nanjing Medical University,Nanjing Jiangsu 210011,China)

机构地区：[1]南京医科大学第二附属医院检验医学中心,江苏南京210011

出　　处：《医疗装备》2018年第17期68-71,共4页Medical Equipment

摘　　要：目的验证与评价XE-2100D血细胞分析仪性能指标。方法参照中华人民共和国卫生行业标准相关文件及EP15-A2的要求,对XE-2100D血细胞分析仪的指标进行评价。结果 XE-2100D血细胞分析仪本底计数结果均为0;白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、血小板(PLT)携带污染率(CR)分别为0.05%、0.00%、0.00%、0.48%,线性回归方程斜率分别为1.001、1.001、0.997、1.002;对2017年卫计委临检中心第1次全血细胞计数5个水平的室间质控品的8个项目[WBC、RBC、PLT、Hb、血细胞比容(HCT)、平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)]测定结果的相对偏差值评价准确度,结果均符合卫计委临检中心的要求;不同进样模式检测结果间的相对偏差值均符合卫生行业标准相关文件要求;参考区间的验证结果提示,各参数的符合度均≥90%。结论 XE-2100D血细胞分析仪准确度、精密度、线性范围、参考区间等指标均达到实验室标准文件要求,可用于临床血细胞分析标本的检测。ObjectiveTo discuss the performance verification and evaluation of XE-2100D blood cell analyzer. MethodsAccording to relevant documents of People＇s Republic of China health industry standards and the requirements of EP15-A2, the indexes of the XE-2100D blood cell analyzer were evaluated. ResultsThe background counting result of XE-2100D blood cell analyzer was 0; the carryover rate （CR） of white blood cell （WBC）, red blood cell （RBC）, hemoglobin （Hb） and platelet （PLT） was 0.05%, 0.00%, 0.00% and 0.48% respectively; the slope of the linear regression equation was 1.001, 1.001, 0.997 and 1.002 respectively. Accuracy was evaluated by the relative deviation values of the results of 8 detection projects including WBC, RBC, PLT, Hb, hematocrit （HCT）, mean red cell volume （MCV）, mean corpuscular hemoglobin content （MCH）, mean corpuscular hemoglobin concentration （MCHC） of the National Health and Family Planning Commission first complete blood cell count interventricular quality control （5 levels） in 2017, and the results complied with the requirements of the National Health and Family Planning Commission. The relative deviation of the results between different sample detection modes were consistent with the requirements of the health industry standard relevant documents. The verification results of the reference range indicated that the parameters were greater than 90%. ConclusionThe accuracy, precision, linear range, reference range and other indicators of the XE-2100D blood cell analyzer all comply with the requirements of laboratory standard documents, so the analyzer can be used for the detection of clinical blood cell analysis specimens.

关 键 词：血细胞分析仪 全血细胞计数 性能验证 

分 类 号：TH7[机械工程—仪器科学与技术]