Performance evaluation of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer / 中国医师杂志

ABSTRACT

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 rangeWBC (0.2 ～ 137.3) × 109/L,RBC(0.72 ～ 7.66) × 1012/L,HGB (20 ～ 231)g/L,PLT(25 ～983) × 109/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.