摘要
参考国内外的标准和文献,总结了临床肿瘤标志物免疫测定过程中肿瘤标志物免疫测定标准化的各个因素。临床标本采集、运送和保存的标准化、检测试剂和方法的标准化、检测结果分析的标准化以及标准物质是肿瘤标志物免疫测定标准化的4个要素。在肿瘤标志物免疫测定标准化各要素中,标准物质是获得具有可比性结果的前提,试剂方法、结果分析和工作程序的标准化,也是不可或缺的要素。标准化是实现肿瘤标志物免疫测定结果可比性的前提,而标准化并非是单一因素,其由诸多关键性环节组成,核心是标准物质的研制及应用。通过阐明肿瘤标志物免疫测定标准化的各个因素,为提高肿瘤标志物免疫测定的准确性和结果的可比性提出了建议。
Referring to the standard and documentation,the various factors in the process of tumor markers immunoassays standardization were aggregated.The standardization of clinical sample collection,transportation and preservation,test reagents and methodology,reference materials application were four elements in tumor markers immunoassay standardization.As to the four elements,reference materials was premise to obtain comparable results.And it was essential that results analysis,reagent and methods,and standardization of procedures.Standardization is the premise to realize comparability of tumor markers immunoassay results.Standardization was composited by many critical factors,the core was reference materials development and application.By clarifing the tumor markers immunoassay standardization of various factors,suggestion to improve tumor markers immunoassay accuracy and comparability of the results was proposed.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第9期1800-1803,共4页
Chinese Journal of Pharmaceutical Analysis
基金
体外诊断试剂国家标准品
参考品标定及复核项目(2011604)资助
关键词
肿瘤标志物
标准化
标准物质
tumor markers immunoassay
standardization
reference materials
