雅培ARCHITECT i2000SR型全自动免疫发光仪测量3种肿瘤标记物的性能验证  

The Performance Validation of Three Kinds Tumor Markers Measured by ABBOTT ARCHITECT I2000

作　　者：刘洋[1] 葛亮[1] 顾万建[1] 徐天[1] 

机构地区：[1]江苏省中医院检验科,南京210029

出　　处：《航空航天医学杂志》2014年第10期1354-1357,共4页Journal of Aerospace medicine

摘　　要：目的通过对科室购入的雅培ARCHITECT i2000SR型全自动免疫发光仪3种瘤标志物的性能验证,探讨全自动免疫发光仪合适有效的验证方案和实验方法。方法按CLSI推荐的方法测定3种肿瘤标志物(CAl25Ⅱ,CA153,CAl99-XR)的精密度、准确度、性范围、生物参考区间,并进行验证。结果 3项肿瘤标志物的方法学评价结果均符合本科室的质量要求。结论雅培ARCHITECT i2000化学发光分析仪检测系统性能满足临床和科室要求,评价方案科学适当。仪器应按要求保养,每年至少进行一次性能验证。设备商提供的数据必须经过科室严格的性能评价,以验证厂家声明,保证实验结果准确可靠。Objective By validating the performance of three kinds tumor marks to explore appropriate and effective programs of verification and experimental methods for automatic immune luminescence instrument .Results Three tumor markers methodological evaluation results are in line with the quality of the undergraduate chamber .Conclusions The performance of Abbott ARCHITECT i 2000 chemiluminescent analyzer system meet the requirements of clinical and labo -ratory.The evaluating programs are scientific and appropriate .The instrument must be maintained according to the re-quirements and complete performance verification at least once a year.Data supplied by equipment must undergo rigorous performance evaluation of department to verify the declare of manufacturers so ensuring the accurate and reliable results .

关 键 词：性能评价 CLSI EP5-A2文件 肿瘤标记物 

分 类 号：R446[医药卫生—诊断学]