迈瑞BC-5500全自动血细胞分析仪性能的初步评价

Performance Evaluation of BC-5500 Hematology Analyzer

目的:评价BC-5500全自动血细胞分析仪全血细胞计数(CBC)和白细胞分类(DC)的性能。方法:按照有关文件规定对该仪器CBC的性能指标进行评价,并与人工分类进行比较。结果:该仪器CBC的精密度、携带污染率和总重复性均符合要求;在正常及常见的病理范围线性良好;与XE-2100的结果进行比较,其相关性好(r>0.99)。DC:中性粒细胞(Neut)、淋巴细胞(Lym)、单核细胞(Mon)、嗜酸性粒细胞(Eos)和嗜碱性中粒细胞(Baso)的重复性好;WBC形态正常的样本,仪器与人工DC的结果进行比较,Neut、Lym和Eos相关性较好(r值为0.968～0.983);Mon次之(r=0.917),Baso的相关性欠佳(r=0.659)。较高比例的杆状核粒细胞、异常/异形Lym和幼稚细胞可出现WBC散点图变化或报警。结论:该仪器检测的结果准确、可靠,主要性能指标符合实验要求;对怀疑WBC分类异常的标本,仪器DC结果必须经显微镜复核后才能报告。

Objective To evaluate the performance of BC-5500 hematology analyzer. Methods The indexes including precision, total reproducibility, carry-over, linearity （dilution effect） and comparability were examined according to published evaluation standard. At the same time, comparison of differential count （DC） produced by the analyzer and manual methods. Results Precision, carry-over and total reproducibility in counting of leucocytes, erythrocytes, platelets and examming of hemoglobin on the analyzer were showed in the prescriptive range. There were also good linearity in normal and pathological range and the results correlated well with those obtained on Svsmex XE-2100 （r〉0.99）. DC：reproducibility was good for neutrophils, lymphocytes monocytes, eosinophils and basophils. Comparison of the results by instrument with manual for normal samples in morphology, the correlation was better for neutrophils, lymphocytes and eosinophils （r：0.968-0.983） ,good for monocytes（r=0.917）, not good for basophils（r=0.659）;The WBC scattergram would change and alarm flags would display when there are neutrophilic stab granulocytes, abnormal or atypical lymphocytes and immature cells in higher proportion.Conclusions The analyzer can be used to test blood Cell parameters accurately and reliably. Its main performance indices accorded with the experimental requirements; The results were credible. It is necessary to check with microscopy for DC before reported when it were doubtted.