Sysmex XN20 A1全自动血细胞分析仪性能评价

Evaluation for the performance of Sysmex XN20 A1 automation blood cell analyzer

目的:对Sysmex XN20 A1全自动血细胞分析仪的主要性能指标进行实验室验证,评价其性能是否符合血液分析仪临床应用的质量要求。方法:对Sysmex XN20 A1全自动血细胞分析仪的精密度、携带污染率、仪器检测线性范围、空白计数、正确度以及不同吸样模式的可比性进行验证,对低值血小板进行光学法和染料法的检测比较。结果:经验证仪器的各项检测项目,其携带污染率<0.4%,空白测试及精密度均满足设备要求;线性验证白细胞(WBC),红细胞(RBC)、血红蛋白(HGB)和血小板(PLT)均满足a值在1±0.05范围内、相关系数r>0.975的要求,仪器线性范围良好;正确度验证标本检测均值与定值的偏倚满足正确度要求;不同吸样模式各检测项目的相对差异能够满足可比性的要求;采用染料法检测低值PLT变异系数CV<4%。结论:Sysmex XN20 A1全自动血细胞分析仪具有良好仪器应用性能,能够满足大多数临床实验室的工作需求。

Objective： To evaluate the performance for the Sysmex XN20 A1 automation blood cell analyzer. Methods： The precision, contaminative rate, linear range, blank, accuracy and various sample models were verified, and low values of blood platelet were compared with the methods of microscopy and dye. Results： The contaminative rate was lower than 0.4%. The linear arrange and precision were well for the analyzer. The values of RBC, HGB and PLT were within the range of 1±0.05 and the correlation coefficients were higher than 0.975. The bias of average and constant values by the accuracy verification samples test met the demands of accuracy. And the relative differences of various sample models meet the requirements of the comparability. The variable coefficient of low values of PLT was lower than 4% by the dye method. Conclusion： The Sysmex XN20 A1 automation blood cell analyzer has the characteristics of perfect precision, accuracy, low contaminative rate, broad linear arrange and good repeatability for the low level PLT. It can be applied in clinical laboratory.