Beckman Coulter ACT-5DIFF AL全自动五分类血液分析仪性能评价  

Performance evaluation of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer

作　　者：陶亚[1] 丘世飏[1] 胡丽涛[1] 

机构地区：[1]中南大学湘雅医院检验科,长沙410008

出　　处：《中国医师杂志》2014年第10期1364-1369,共6页Journal of Chinese Physician

摘　　要：目的 验证Beckman Coulter ACT-5DIFF AL全自动五分类血细胞分析仪性能是否满足临床要求.方法 对该检测系统的携带污染率、正确度、精密度、不确定度、分析测量范围、参考区间、进样模式等指标进行性能评价.结果 各参数携带污染率均为0.18％;根据卫生部临检中心血细胞正确度验证结果回报,与靶值比较,偏倚在0.32％ ～2.29％范围内;各参数不同浓度的实验室变异系数即精密度在0.35％～4.46％范围之内,均＜1/3 CLIA＇88能力验证分析质量要求.各参数的扩展不确定度分别为UwBC低=7.4％,UwBC高=3.8％,URBC低=3.4％,URBC高=2.8％,UHGB低=3.9％,UHGB高=2.2％,UPLT低=9.8％,UPLT高=7.6％,UMCv低=2.6％,UMCv高=2.5％.分析测量范围较广：白细胞（WBC）在（0.2～137.3）×10^9/L内,红细胞（RBC）在（0.72～7.66）×10^12/L内,血红蛋白（HGB）在20～231 g/L内,血小板（PLT）在（25 ～983）×10^9/L内,红细胞比积（HCT）在6.1％ ～68.0％内呈线性,各参数线性回归的相关系数接近1.0;引用的参考区间合适;自动与手动进样模式检测结果无明显差异;白细胞五分类验证合格.结论 ACT-5 DIFF AL全自动血细胞分析仪,在室内质控通过的情况下,各性能指标基本达到实验室质量要求,并能较好的满足临床需求.Objective To evaluate the performance of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer and to verify whether it meets the clinical requirement.Methods The residual contamination rate,accuracy,precision,uncertainty,measurement range,reference interval,and sample injection pattern of detecting system were evaluated.Results The residual contamination of each parameter was less than or equal to 0.18%.According to room between qualitative evaluation results,compared to the target value,bias ranged from 0.32% to 2.29%.Different concentrations of laboratory variation coefficient （namely precision） of each parameter ranged from 0.35% to 4.46%,and both of which were less than a third of the CLIA＇88 ability verification analysis quality requirements.The expanded uncertainty of each parameter was Uwhite blood cell （WBC） low =7.4%,UWBC high =3.8%,Ured blood cell （RBC） low =3.4 %,U RBC high =2.8 %,Uhemoglobin （HGB） low =3.9 %,UHGB high =2.2 %,Uplatelet （PLT） low =9.8 %,UPLT high =7.6%,UMCV low =2.6%,and UMCV high =2.5%.Analysis had a wide measuring range：WBC （0.2 ～ 137.3） × 10^9/L,RBC（0.72 ～ 7.66） × 10^12/L,HGB （20 ～ 231）g/L,PLT（25 ～983） × 10^9/L,and hematocrit （HCT） （6.1 ～68.0）%.All of them had a linear relationship,and the correlation coefficient of linear regression was close to 1.0.The reference interval quoted was suitable.Both of the automatic and the hand sample injection pattern had no significantly difference in result detection.Five categories of WBC were verified up to standard.Conclusions Under the circumstance of indoor quality control approved,each performance indicator approximately reached the laboratory quality requirements,and it also met the clinical requirements.

关 键 词：血细胞计数/仪器和设备 自动分析/仪器和设备 血液化学分析 

分 类 号：R446.1[医药卫生—诊断学]