血细胞分析仪配套试剂检测系统与非配套试剂检测系统的误差分析

目的评价SysmexKX-21N血细胞分析仪非配套试剂检测系统的应用。方法用配套校准品校准配套试剂检测系统,再用此检测系统定值后的新鲜全血校准非配套试剂1检测系统和非配套试剂2检测系统;分别对各检测系统做批内、批间精密度测定;以配套试剂检测系统为比较方法,非配套试剂检测系统为实验方法,采集40份住院患者的新鲜全血样本,分别用配套试剂检测系统和非配套试剂检测系统1、2,对白细胞（WBC）、红细胞（RBC）、血红蛋白（HGB）、红细胞压积（HCT）和血小板（PLT）等参数进行检测;以小于美国临床实验室修正法规（CLIA’88）推荐的允许误差的1／4作为批内允许误差,1／3作为批间允许误差,1／2为医学决定水平的系统偏差（SE％）为可接受范围,进行各检测系统批内、批间精密度、相关性和偏差评价。结果各检测系统批内、批间精密度均在允许范围内,用配套试剂与非配套试剂1、2检测系统测定各参数的相关系数（r）均大于0．975,医学决定水平的系统偏差（SE％）均在可接受范围内。结论在血细胞分析仪检测系统精密度良好、用新鲜全血对非配套检测系统校准的前提下,配套试剂检测系统与非配套试剂检测系统各参数的测定结果均具有良好的准确性和可比性。

The error analysis between necessary and non-necessary reagent detection systems of hematology analyzer

Objective To evaluate the application of non-necessary reagent detection system of the Sysmex KX-21N hematology analyzer. Methods The necessary reagent detection system was calibrated with the necessary calibration preparation. The non-necessary reagent 1 and 2 detection systems were calibrated by the fresh whole blood which had been rated by the necessary reagent detection system. Then the intra- and inter-batch precision examination was done about each examination system.According to the demand of National Committee for Clinical Laboratory Standards (NCCLS) EP9-A2document, the necessary reagent detection system was taken as the comparison method and the nonnecessary reagent detection system as the experimental method, 40 cases of inpatient's fresh whole blood samples were collected, and then by applying the necessary and non-necessary reagent detection system 1, 2, WBC count, RBC count, hemoglobin (HGB), hematocrit (HCT) arid blood platelet (PLT) were respectively detected. Taking the error which is smaller than 1/4 of the allowable error recommended by CLIA'88 as the allowable error of intra-batch, 1/3 as allowable error of inter-batch,1/2 as the accepted range of medicine decision level of the system deviation (SE%), the appraisement of the intra- and inter-batch precision, relevance and deviation of each detection system was carried out. Results The intra- and inter-batch precision of each detection system was in the allowable range,and the parameter's correlation coefficient (r) was more than 0. 975, and the acceptable range of medicine decision level of the system deviation (SE%) was in the allowable range. Conclusion There are favourable accuracy and comparability between the parameters detection results of necessary and nonnecessary detection systems under the prerequisite of good accuracy of detection systems of hematology analyzer and correct calibration of non-necessary with fresh whole blood.