乳腺癌患者血清HER-2/neu蛋白化学发光免疫定量分析方法的建立  

Establishment of quantitative chemiluminescence immunoassay for serum HER-2/neu protein in the patients with breast cancer

作　　者：唐红辉[1] 徐海伟 TANG Hong-hui XU Hai-wei(Department of Laboratory Medicine, Xuzhou Cancer Hospital, Xuzhou 221000, Jiangsu Suzhou Hybiome Biomedical Engineering Co. Ltd , Suzhou 215163, Jiangsu , China)

机构地区：[1]徐州市肿瘤医院检验科,江苏徐州221000 [2]苏州长光华医生物医学工程有限公司,江苏苏州215163

出　　处：《临床检验杂志》2016年第7期548-551,共4页Chinese Journal of Clinical Laboratory Science

摘　　要：目的建立吖啶酯化学发光免疫分析定量检测乳腺癌患者血清HER-2/neu蛋白的方法。方法用吖啶酯和生物素分别标记2株不同的HER-2/neu蛋白单克隆抗体,并用链霉亲合素包被微粒,通过链霉亲合素-生物素系统分离固相和液相,采用双抗体夹心法对建立方法的性能指标进行鉴定评估。结果建立的方法线性范围5~300 ng/m L,最低检测限为0.58ng/m L,批内变异系数≤3.0%,总变异系数≤8.8%,与西门子公司HER-2/neu蛋白测定试剂盒（化学发光法）的检测结果比对,相关系数（r）=0.991 9,总符合率98.9%。结论建立的方法能够满足乳腺癌的临床诊疗要求,值得在临床推广应用。Objective To establish a quantitative acridine ester chemiluminescence immunoassay method for the detection of serum HER-2/neu protein in the patients with breast cancer. Methods Two different monoclonal antibodies against HER-2/neu protein were labeled with acridine ester and biotin,respectively,and microparticles were coated with streptavidin. Based on the separation of solid and liquid phases by the streptavidin-biotin system,the double-antibody sandwich method was established and its detection performance was evaluated. Results The linearity range,lowest detectable limit,intra-batch coefficient of variance（ CV） and total CV of the established method were 5-300 ng/m L,0. 58 ng/m L,≤3. 0% and ≤8. 8%,respectively. The coefficient of correlation（ r） and total coincidence rate of the results from the established method and the HER-2/neu protein assay kit（ Chemiluminescent assay,Siemens Co.） were 0. 991 9 and 98. 9%,respectively. Conclusion The established method can meet the clinical diagnosis and treatment requirements of breast cancer,and may be applied in clinical laboratories.

关 键 词：HER-2/NEU蛋白 化学发光 吖啶酯 免疫定量分析 

分 类 号：R446.61[医药卫生—诊断学]