应用CLSI文件对化学发光免疫分析系统性能的初步评价

Preliminary Evaluation of the Performance of the Chemiluminescent Immunoassay System by CLSI File

目的:评价BECKMAN ACCESS2全自动微粒子化学发光免疫分析系统相关性能。方法:以测定游离三碘甲状腺原氨酸(FT3)为例,收集患者高、中、低值新鲜血清混合标本,应用CLSI颁布的EP10-A2对ACCESS2全自动化学发光免疫分析系统进行初步评价。结果:通过CLSI EP10-A2程序评价显示ACCESS2检测系统偏差、不精密度、交叉污染、线性漂移等因素都在可接受范围内,对精密度无明显影响。结论:ACCESS2全自动发光免疫分析系统分析性能可靠,适合临床实验室使用。

Objective：To evaluate the performance of Beckman Access2 automated chemiluminescent immunoassay system in order to know its status. Method：Using the CLSI document EP10-2A for preliminary evaluation methods to approve the high,medium and low fresh serum of patients which were adopted as samples and was assayed FT3 in Beckman Access2 testing system.Result：The factors of carryover and drift,system deviation,imprecision,cross contamination in the ballpark,they had no effect on precision.Conclusion：The performance of Beckman Access2 automated chemiluminescent system is reliable and suitable for clinical laboratory to use.