BC-5500全自动血细胞分析仪性能评估报告

Evaluation of BC-5500 automated hematology analyzer

目的对新购进的迈瑞BC-5500全自动血细胞分析仪的各项性能进行系统评估并汇总报告。方法按照国际血液学标准化委员会(ICSH)制定的评价标准进行。结果各参数携带污染率皆符合ICSH小于1%的要求且线性良好(r≥0.995);总重复性除血红蛋白(HB),平均红细胞血红蛋白量(MCH)略微超出外,其他各项均满足1/4美国临床检验修正法规(CLIA′88)要求;在与华西医科大学附属第二医院检验科所使用XE-2100及本科室所使用XE-2100比对中,除平均红细胞血红蛋白浓度(MCHC)的相关性欠佳外,各参数均有良好的相关性(r≥0.975);批间精密度各参数均满足1/3CLIA′88要求;除手动低、中值MCH和MCHC略微超出外,批内精密度均满足1/4CLIA′88要求;各项参数在与华西医科大学附属第二医院检验科所使用XE-2100及本科室所使用XE-2100比对中均在偏倚允许范围内;白细胞分类的重复性及准确性均符合要求。结论本机各项评估试验均达到评估要求,可以接受使用。对于个别结果欠佳的参数,将在日常使用及下次评估中继续观察。

Objective To evaluate the performance of BC - 5500 automated hematology analyzer. Methods The evaluation was based on the guidelines of International Council for Standardization in Haematology （ ICSH ）. Results The carryover of all the parameters were conformed to the standard of ICSH （ 〈 1% ） and the linearity was excellent （ r≥0. 995 ）. The total reproducibility fulfilled the requirements of the Clinical Laboratory Improvement Amendments of 1988 （CLIA88） except the measurements of HB and MCH which were slightly high. In comparison with XE -2100 analyzer, most parameters except MCHC had good relevance （r≥0. 975 ）. The inter- batch precision fulfilled the requirements of CLIA＇ 88 ; the intra - precision fulfilled the requirements of CLIA ＇88 except MCH and MCHC which were slightly high by manual pattern. The bias of the parameters detected by BC -5500 analyzer and XE -2100 analyzer was also acceptable. The reproducibility and accuracy of white blood cell classification were conformed to the standards. Conclusion In general, the performance evaluation indicates BC - 5500 automated hematology analyzer we tested met the requirements of CLIA88 regulations. Further monitoring is needed for the parameters which show unsatisfactory result in this evaluation.