The performance evaluation of dry-type blood cell analyzer / 中华检验医学杂志

ABSTRACT

Objective A comparability analysis was performed between the various parameters of the self-developed dry-type blood cell analyzer with the reference instrument (Sysmex XT-1800i).Methods In line with the evaluation program of blood cells issued by ICSH,the detection results,six parameters as HCT,Hb,GRAN (granulocytes),LM (lymphatic and monocytes),WBC and PLT,were compared between the two instruments.Some indexes of the subject instrument such as precision,comparability,outlier points,bias,etc.were analyzed and compared so as to calculate the equation of linear regression and the expected bias intervals.Results The intra and inter CV of the subject instrument about six parameters were respectively less than 5％ and 6％,so it showed that the instrument had good precision.Correlation analysis showed that the classification results of HCT,Hb,GRAN and WBC had a good correlation (r =0.991,0.972,0.986,0.975,P ＜0.01),while that of LM and PLT were slightly lower (r =0.952,0.942,P ＜0.01) ; As to the medical decision level,HCT values were 14％ and 70％,WBC 0.5 × 109/L and 3 ×109/L,and PLT 10 × 109/L,50 × 109/L and 100 × 109/L,and the acceptable bias of these values all fell in the confidence intervals; the values of the rest items were slightly higher than the high value of the confidence interval of expected bias.Conclusions The subject instrument produces the same results in the test of its parameters as the reference instrument Sysmex XT-1800i and therefore the two instruments are comparable.The subject instrument is particularly suitable for field rapid detection.