Sysmex-XN全自动血细胞分析仪性能评价  

The Performance Evaluation of Sysmex-XN Automatic Hematology Analyzer in Complete Blood Count

作　　者：毛志刚[1] 金咏梅[1] 郑沁[1] 曾婷婷[1] 陈月梅[1] 粟军[1] 

机构地区：[1]四川大学华西医院实验医学科,成都610041

出　　处：《华西医学》2014年第5期871-874,共4页West China Medical Journal

基　　金：国家自然科学基金(81101327)~~

摘　　要：目的对Sysmex XN—B3全自动血细胞分析仪进行性能评价。方法对Sysmex XN-B3全自动血细胞分析仪的精密度、携带污染率、仪器检测线性范围、空白计数、仪器间的比对进行评价。结果Sysmex XN-B3全自动血细胞分析仪的批内精密度和批间精密度小于美国临床实验室改进修正法规’88（CLIA＇88）规定的总允许误差的1／4，仪器精密度良好。携带污染率最高为0．12％，符合厂家要求≤1．00％。仪器检测线性范围：白细胞计数为（0．51～393．40）×10^9／L，红细胞计数为（0．51～8．15）×10^12／L，血红蛋白浓度为15．0～244．5g／L，血小板计数为（3．0～2072．5）×10^9／L。空白试验均符合厂家要求。比对试验符合原卫生部关于《临床血液学检验常规项目的分析质量要求》2012版规定的偏差范围，同时也符合1／2CLIA＋88要求的偏差范围。结论Sysmex XN血细胞分析仪具有良好的精密度，极低的携带污染率，宽广的线性范围，其检测结果准确可靠，能够满足绝大多数临床实验室的工作需求。Objective To evaluate the complete blood count performance quality of Sysmex-XN automatic hematology analyzer. Methods We investigated the precision rate, residual contamination rate, analytic linearity range, and background counting of Sysmex-XN-B3 analyzer. Results The inner and inter-group precision test showed that the inaccuracy of the analyzer was lower than the allowable standard of 1/4 （CLIA＇88）. The highest level of residual contamination rate was 0.12%, lower than the standard of manufacturer （ ≤ 1%）. Linearity evaluation showed that the white blood cell count analytic linear range was from 0.51 × 109/L to 393.40×109/L, the red blood cell count analytic linear range was from 0.51 × 10^12/L to 8.15 × 10^12/L, the hemoglobin analytic linear range from 15.0 g/L to 244.5 g/L, and the platelet count analytic linear range was from 3.0× 10^9/L to 2 072.5 × 10^9/L. Background counting was also lower than the standard of manufacturer. Comparison between the two different series of analyzers showed that the inaccuracy rate of Sysmex-XN-B3 was not only lower than the standard of National Center for Clinical Laboratories, but also lower than the standard of 1/2 （CLIA＇88）. Conclusions Sysmex-XN automatic hematology analyzer has a high performance in capability evaluation. It is an excellent tool for routine hematologic blood examination.

关 键 词：SYSMEX XN血细胞分析仪 性能评价 精密度 可比性 携带污染率 

分 类 号：R446.1[医药卫生—诊断学]