关键词: 乳腺癌, HER2, 化学发光法, 性能评价, 等效性

Abstract: This study established magnetic particles chemiluminescence method for the detection of serum human epidermal growth factor receptor 2(HER2)protein in the patients with breast cancer, and evaluated its performance and equivalence with market products. The detection range of HER2 protein was from 0 to 300 ng/mL; limit of blank(LoB)was 0.48 ng/mL; average recovery rates of exogenous and endogenous interference was lower than 5%; precision was coefficient of variation(CV)lower than 8%; the stability test showed that the reagent could be stored stably for 48 weeks, and the correlation coefficient with commercial products was r=0.995, the mean bias was -0.2 ng/mL. These results indicated that the detection method of serum HER2 protein was successfully established, and had an excellent- DOI:10.3969/j.issn.1000-1565.2022.03.009血清HER2蛋白化学发光免疫检测方法的建立及评价王娟^1,2,程华³,胡琛光^4,5,林斯^4,5,于飞^{1, 2},刘涛¹,刘朋朋¹(1.河北农业大学 河北野生动物健康研究中心,河北 保定 071000;2.河北农业大学 生命科学学院,河北 保定 071000;3.河北省科学院 生物研究所,河北 石家庄 050081;4.北京华科泰生物技术股份有限公司,北京 101111;5.天津华科泰生物技术有限公司,天津 300405)摘 要:为检测乳腺癌患者血清人表皮生长因子受体2(HER2)蛋白,基于磁微粒化学发光免疫平台建立了血清HER2蛋白检测方法并评价其性能和市场产品等效性.结果显示:本研究建立的血清HER2蛋白检测方法检测范围为0~300 ng/mL;空白限(limit of blank, LoB)为0.48 ng/mL;外源性和内源性干扰平均回收率<5%;精密度变异系数(coefficient of variation,CV)<8%;稳定性实验显示,试剂可稳定储存48周,且与市售产品相关系数r为0.995;平均偏倚为-0.2 ng/mL.提示本研究成功建立了HER2蛋白检测方法,且各项分析性能表现优异,与在售化学发光试剂等效性良好,可为临床应用提供科学的数据参考.关键词:乳腺癌;HER2;化学发光法;性能评价;等效性中图分类号:R737.9 文献标志码:A 文章编号:1000-1565(2022)03-0281-07Establishment and performance evaluation of chemiluminescent immunoassay for serum HER2 proteinWANG Juan^1,2, CHENG Hua³, HU Chenguang^4,5, LIN Si^4,5, YU Fei^1,2, LIU Tao¹, LIU Pengpeng¹(1. Hebei Wildlife Health Center, Hebei Agricultural University, Baoding 071000, China;2. College of Life Science, Hebei Agricultural University, Baoding 071000, China;3. Institute of Biology, Hebei Academy of Sciences, Shijiazhuang 050081, China;4. Beijing Savant Biotechnology Co. Ltd., Beijing 101111, China;5. Tianjin Savant Biotechnology Co. Ltd., Tianjin 300405,China)Abstract: This study established magnetic particles chemiluminescence method for the detection of serum human epidermal growth factor receptor 2(HER2)protein in the patients with breast cancer, and evaluated its performance and equivalence with market products. The detection range of HER2 protein was from 0 to 300 ng/mL; limit of blank(LoB)was 0.48 ng/mL; average recovery rates of exogenous and endogenous interference was lower than 5%; precision was coefficient of variation(CV)lower than 8%; the stability test showed that the reagent could be stored stably for 48 weeks, and the correlation coefficient with commercial products was r=0.995, the mean bias was -0.2 ng/mL. These results indicated that the detection method of serum HER2 protein was successfully established, and had an excellent- 收稿日期:2022-01-12 基金项目:国家重点研发计划项目(2020YFC084310);河北省科学院科技攻关项目(21313) 第一作者:王娟(1989—),女,河北廊坊人,河北农业大学副教授,主要从事抗肿瘤药物筛选和相关机制研究.E-mail: wangjuan@hebau.edu.cn 通信作者:刘朋朋(1985—),男,河北赵县人,河北农业大学研究员,博士,主要从事体外诊断技术研究.E-mail: liupeng@cwbz.ac.cn第3期王娟等:血清HER2蛋白化学发光免疫检测方法的建立及评价performance compared with HER2 protein chemiluminescence reagents sold on the market.

Key words: Breast cancer, HER2, chemiluminescence, performance evaluation, equivalence