Sysmex XN-L-550全自动血细胞分析仪性能验证及评价  

Performance verification and evaluation of Sysmex XN-L-550 automatic blood cell analyzer

作　　者：何文军[1] 钟伟国[1] 李曼[1] HE Wen-jun;ZHONG Wei-guo;LI Man(Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510370,China)

机构地区：[1]广州中医药大学第二附属医院广东省中医院

出　　处：《医疗卫生装备》2019年第6期48-51,共4页Chinese Medical Equipment Journal

基　　金：广东省中医院综合标准化试点重点示范项目(YN2015BZ10)

摘　　要：目的:对SysmexXN-L-550全自动血细胞分析仪的主要性能进行验证和评价。方法:参照WS/T406—2012《临床血液学检验常规项目分析质量要求》、WS/T405—2012《血细胞分析参考区间要求》及美国临床和实验室标准化委员会相关文件,以靶机SysmexXE-5000全自动血细胞分析仪为参照仪器,对SysmexXN-L-550全自动血细胞分析仪的检测项目白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞比容(HCT)、血小板(PLT)、红细胞平均体积(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)的本底计数、携带污染率、精密度、正确度、仪器不同吸样模式的结果可比性、实验室内的结果可比性、参考区间、线性范围进行验证。结果:该仪器的WBC、RBC、Hb、PLT本底检测结果良好;WBC、RBC、Hb、PLT携带污染率均为0.00%,符合标准要求;WBC、RBC、Hb、HCT、PLT、MCV、MCH、MCHC批内和批间精密度的变异系数均小于参考值;以SysmexXE-5000全自动血细胞分析仪的测定均值为标准,偏倚分别为WBC4.01%、RBC0.10%、Hb0.56%、HCT1.44%、PLT3.69%、MCV1.31%、MCH0.42%、MCHC-0.95%,均低于允许偏差;与SysmexXE-5000全自动血细胞分析仪的比对结果及自动和手动吸样模式的比对结果均具有可比性;参考区间符合实验室检测人群,线性范围宽。结论:SysmexXN-L-550全自动血细胞分析仪各项性能指标验证结果良好,可满足临床检测要求。Objective To verify and evaluate the main performances of Sysmex XN-L-550 automatic blood cell analyzer. Methods According to WS/T 406-2012 Analytical quality specifications for routine tests in clinical hematology, WS/T 405-2012 Reference intervals for blood cell analysis and related documents of Clinical and Laboratory Standards Institute of the United States Sysmex XN-L-550 blood cell analyzer had its indexes verified including background count of WBC, RBC, Hb, HCT, PLT, MCV, MCH and MCHC, carryover, precision, accuracy, results comparability for different sampling modes and labs, reference interval as well as linear range, with Sysmex XE-5000 automatic blood cell analyzer as the reference. Results The analyzer behaved well in background count of WBC, RBC, Hb and PLT;the carryovers of WBC, RBC, Hb and PLT were all 0.00%;the coefficients of variation of within- and inter- assay of WBC, RBC, Hb, HCT, PLT, MCV, MCH and MCHC were all lower than the reference values;when compared with measure values by Sysmex XE-5000 analyzed, the biases of WBC, RBC, Hb, HCT, PLT, MCV, MCH and MCHC were 4.01%, 0.10%, 0.56%, 1.44%, 3.69%, 1.31%, 0.42% and -0.95% respectively, which were all lower than allowable deviations;the results by Sysmex XE-5000 and Sysmex XN-L-550 analyzers as well as by auto and manual sampling were all comparable;Sysmex XN-L-550 analyzer had the reference intervals and linear range meet the requirements. Conclusion Sysmex XN-L-550 automatic blood cell analyzer has good performances and can meet the clinical lab requirements.

关 键 词：全自动血细胞分析仪 性能验证 血液检查 变异系数 精密度 携带污染率 

分 类 号：R318.6[医药卫生—生物医学工程] TH776[医药卫生—基础医学]