生物学杂志

• 技术方法 • 上一篇    下一篇

血清淀粉样蛋白A化学发光免疫检测技术开发

  

  1. 1. 江苏省医疗器械检验所, 南京 210019; 2. 无锡市人民医院, 无锡 214000;3. 江南大学 粮食发酵工艺与技术国家工程实验室, 无锡 214122
  • 出版日期:2019-08-18 发布日期:2019-08-18
  • 通讯作者: 王春新,主任技师、副教授,从事临床检验诊断学研究,E-mail:Wangcx_wxph@163.com
  • 作者简介:周齐洋,硕士研究生,主要从事体外诊断试剂检验工作,E-mail:2437578195@qq.com
  • 基金资助:
    863课题(编号:2015AA020802) 

Development of chemiluminescent immunoassay for human serum amyloid A

  1. 1. Jiangsu Testing and Inspection Institute for Medical Devices, Nanjing 210019;2. Wuxi People′s Hospital, Wuxi 214000; 3. National Engineering Laboratory for Cereal Fermentation Technology, Jiangnan University, Wuxi 214122, China
  • Online:2019-08-18 Published:2019-08-18

摘要: 旨在建立一种灵敏、快速、稳定的血清淀粉样蛋白A(SAA)的检测方法。采用微孔板式定量化学发光法检测人血清中SAA的含量,反应原理为双抗夹心法。建立的化学发光法标准曲线r2>0.99,线性范围为5~800 ng/mL,最低检测限为3 ng/mL,批内精密度和批间精密度(CV)分别小于8%和10%,与西门子检测结果相关性较好,r2为0.98。建立的血清淀粉样蛋白A的检测方法重复性好,线性范围宽,灵敏度高,完全满足临床测定需求。

关键词: 血清淀粉样蛋白A, 化学发光免疫检测技术, 性能评估

Abstract: This paper aims to develop a sensitive, rapid and stable method that can be used in clinical detection of human serum amyloid A. We established a sandwich chemiluminescent immunoassay(CLIA) method to detect human serum amyloid A quantity in blood samples, and its performance was evaluated. The correlation of standard curve was higher than 0.99. The linear range was 5-800 ng/mL. The detection limit of the method was 0.5 ng/mL. Within-run and between-run precision were lower than 8% and 10%, respectively. One hundred and fifty clinical samples were collected to evaluate the methodological consistency between the developed method and Siemens Kit, and the linear regression results showed a great correlation with r2 higher than 0.98. 

Key words: human serum amyloid A, chemiluminescent immunoassay, performance evaluation

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