临床样本分离白细胞在SysmexXN血细胞分析仪性能验证中的应用  

Verification of the Performance of Sysmex XN Hematology Analyzer with the White Blood Cells Which Separated from Clinical-samples

作　　者：王力[1] 郑翠玲[1] 韩晓红[1] 许晓娜[1] 齐军[1] 

机构地区：[1]中国医学科学院肿瘤医院检验科,北京100021

出　　处：《标记免疫分析与临床》2015年第9期927-930,共4页Labeled Immunoassays and Clinical Medicine

基　　金：北京希望马拉松专项基金资助(LC2012A05)

摘　　要：目的 制备高浓度白细胞样本验证Sysmex XN-1000（B3）血细胞分析仪检测白细胞的性能。方法 从30份临床抗凝样本中分离白细胞,按照国家卫生行业标准WS/T 406-2012文件的要求对Sysmex XN-1000（B3）血细胞分析仪检测白细胞的性能进行验证。结果 任意混合多份临床样本分离白细胞可获得高浓度白细胞样本;Sysmex XN-1000（B3）血细胞分析仪检测白细胞的本底计数为0,批内精密度的CV为1.39%,低、中浓度水平质控品的日间精密度的CV分别为2.0%和1.9%,正确度偏倚为1.46%,在0~145.63×109/L检测范围内呈线性关系,携带污染率为0.06%,准确度的相对偏差范围为0.44%~5.74%。结果 任意混合多份临床样本,通过分离、富集可获得高浓度白细胞样本,用于Sysmex XN-1000（B3）血细胞分析仪检测白细胞的性能验证。Objective To prepare high concentration of white blood cell samples and verify the performance of the Sysmex XN-1000 （ B3 ） hematology analyzer in detecting the white blood cells. Methods According to the standard document for national health WS/T 406 -2012, the performance of Sysmex XN-1000 （B3 ）hematology analyzer was verified with the white blood cells which separated from 30 clinical anticoagulation samples. Results High concentration of white blood cell samples were obtained from a random mixture of multiple clinical samples. The background value of the white blood cell measured by Sysmex XN-1000 （B3 ）hematology analyzer was 0,while the CV of within-run precision was 1.39%. The CV of inter-day precision of the low and middle level quality control samples was 2% and 1. 9% respectively, and the bias of trueness was 1. 46%. Furthermore ,the concentration of white blood cell from 0 to 145.63 × 109/L showed a linear relationsh!p ,while the carryover was 0.06%. Finally, the relative deviation range of accuracy was 0.44% -5.74%. Conclusion The white blood cells can be separated from multiple randomly mixed clinical samples, and enriched to reach a high concentration. It can be used in the performance verification of Sysmex XN-1000 （B3 ）hematology analyzer in detecting the white blood cells.

关 键 词：SYSMEX XN-1000(B3) 全自动血细胞分析仪 性能验证 白细胞 

分 类 号：R446.1[医药卫生—诊断学]