化学发光免疫法检测甲胎蛋白临床可报告范围的建立  

Establishing the clinical reportable range of hemiluminscence immunoassay in detection of AFP

作　　者：郑松柏[1] 张秀明[1] 庄俊华[1] 林莲英[1] 徐建华[1] 王建兵[1] 马骥[1] 柯培锋[1] 

机构地区：[1]广东省中医院检验科,广东广州510120

出　　处：《中国现代医学杂志》2008年第14期2069-2071,共3页China Journal of Modern Medicine

基　　金：广东省医学科研基金立项课题(No:A2006252)

摘　　要：目的建立化学发光法检测甲胎蛋白的临床可报告范围。方法参考美国临床检验标准化委员会(NCCLS)EP6-P2文件和相关文献,在Bayer Centaur 240化学发光免疫分析仪上进行甲胎蛋白分析测量范围验证实验、最大允许稀释度验证实验,并结合功能灵敏度建立其临床可报告范围。结果甲胎蛋白的分析测量范围为1.00～912ng/mL,最大允许稀释度为1∶50,与厂商声明基本一致;其临床可报告范围为3.65～45600ng/mL。结论临床可报告范围的建立,对于高值有特别意义的检测项目至关重要。[Objective] To establish the clinicl reportable range of chemiluminscence immunoassay in detection of AFP. [Methods] Referring to NCCLS EP6-P2 evaluation protocols and pertinent literature. We performed the validate experiments of analytical measurement rang and max dilution limit by Bayer Centaur 240 chemiluminscence immunoassay system. Which results combining functional sensitivity would be established the clinical reportable range. [Results] The analytical measurement rang of AFP was 1.00-912 ng/mL, the max dilution limit was 1：50, beth were compared with the declaration of the Manufacturer. And the clinical reportable range was 3.65--45600 ng/ mL. [Conclusions] It is important to establish clinical reportable range for the items, which have special significance at high levels.

关 键 词：临床可报告范围 化学发光免疫检验 甲胎蛋白 分析测量范围 

分 类 号：R446[医药卫生—诊断学]