迈瑞BC5390血液分析仪实验室性能验证

摘要

目的：对迈瑞BC5390血液分析仪的主要性能进行实验室验证。方法依据美国临床和实验室标准化协会（CLSI）系列文件和相关文献，结合该实验室实际工作，对迈瑞BC5390（编号SM‐45000421）的精密度、准确度、线性、临床可报告范围及携带污染率进行测定。结果迈瑞BC5390的本底计数均达到厂商设计规定的要求，检测WBC、RBC、PLT、Hb、HCT、MCV 6项精密度、准确度、线性范围良好，携带污染率低。白细胞分类与人工镜检分类相比，除嗜碱性粒细胞外，均有良好的相关性（r2＞0．95）。结论迈瑞BC5390全自动血细胞分析仪的各项性能良好，精密度及准确度高，线性范围宽，携带污染率低，能较好地满足临床血液常规检查的要求。%Objective To evaluate the performance verification of Mindary BC5390 hematology analyzer .Methods According to requirement of CLSI documents ,the precision ,accuracy ,linearity ,carryover were evaluated .Results The background counts all met the designed requirements of manufacturer .Precision ,accuracy ,linearity of the WBC ,RBC ,PLT ,Hb ,HCT ,MCV were good and the contamination carrying rates were low .Except for basophils ,the classification of leukocyte was well correlated with the artificial microscopy classification(r2 >0 .95) .Conclusion The BC5390 is a ideal automated hematology analyzer which has high precision and accuracy ,wide linearity ,low contamination carrying rate ,and it can be used for the blood samples analysis .