不同型号血细胞分析仪的性能评价及对比分析

Performance evaluation of Orphee-Mythic22 automatic hematology analyzer and the comparative analysis with sysmex XT-1800 I analyzer

目的对瑞士Orphee-Mythic22(检测系统1)全自动血细胞分析仪进行自身系统评价,并与日本希森美康XT-1800i(检测系统2)进行对比分析,确保该设备对于临床检验的准确性。方法检测系统1自身性能评价参照国际血液学标准化委员会(ICSH)制定的标准进行;以本地区使用较多的检测系统2测定结果作为参考方法的测定值,检测系统1测定结果为比对方法的测定值,进行相关回归分析比对。结果检测系统1各项指标线性良好(r>0.993),各参数的携带污染率低(<0.01%);在4℃或室温条件下可稳定48h以上,不精密度的CV均小于5%;高胆红素全血及高三酰甘油、高胆固醇对各参数几乎无干扰(P>0.05);100例标本的血细胞计数及白细胞分类计数结果显示检测系统1与检测系统2相比,二者红细胞、血红蛋白、血小板、嗜中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞分析相关性较好,相关系数r均在0.95左右,而嗜碱性粒细胞相关性较差(r=0.789)。结论检测系统1与检测系统2相比较除嗜碱性粒细胞相关性较差外,其余指标相关性良好。

Objective To evaluate the performance of Orphee-Mythic22 automatic hematology analyzer and contrast with sysmex XT - 1800 I analyzer, in order to ensure the accuracy of the equipments for clinical inspection. Methods The performance of Orphee-Mythic22 was evaluated according to the guidelines of international council for standardization in haematology （ICSH）. The detection results of Sysmex XT - 1800 I were defined as the measured value of reference method, and regression analysis was performed. Results Orphee-Mythic22 had an excellent linear- ity for all indexes （r=0. 993） and the carry--over rate was low（d0.01%）. The stability at room temperature （RT） or 4 ℃ was very stable for 48 h, and imprecision was excellent （CV〈5%）. Interfering study demonstrated minimal interference of high concentration of bilirubin, triglyceride or cholesterol（P〉0.05）. Evaluation of differential count indicated an excellent correlation with the reference method for WBC, RBC, PLT, NEUT, LYPHO,and EO（r= 0.95）. But a poor correlation for BAS（r=0. 789）. Conclusion Orphee-Mythic22 has an excellent correlation for pa- rameters in addition to BAS compared with Sysmex XT - 1800 I. It is an excellent tool for routine hematologic blood examination.