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方法研究

测定癌胚抗原的吖啶酯化学发光免疫分析方法的建立

  • ZHOU Qi-yang ,
  • WANG Nan ,
  • CHEN Xiu-fa
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  • 1.江苏省医疗器械检验所,江苏 南京 210012;2.苏州长光华医生物医学工程有限公司,江苏 苏州 215163
周齐洋(1979—)男,学士,工程师,研究方向:诊断试剂检验。 Tel: 13851494409;E-mail: qiyangzhou@sina.com

网络出版日期: 2013-12-14

Establishment of Acridinium Ester-Chemiluminescence Immunoassay Method for the Determination of Carcinoembryonic Antigen

  • 周齐洋,王楠,陈秀发
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  • Jangsu Province Medical Instrument Testing Institute, Nanjing 210012, China

Online published: 2013-12-14

摘要

摘要: 目的  建立一种定量测定血清中癌胚抗原(CEA)含量的检测方法。方法 根据双抗体夹心法实验原理,利用吖啶酯化学发光免疫分析技术-结合生物素-亲和素磁颗粒分离技术。结果 方法的最低检测限为0.2ng/mL,线性范围为2.2360ng/mL,批内变异为1.9%2.2%,总变异为6.5%8.1%,与ROCHE公司的癌胚抗原检测试剂盒(电化学发光法)测定结果的拟合方程为Y=0.9969X+0.6168,相关系数为r=0.9921结论 本方法的各项指标均满足临床检测的要求,适合临床推广应用。

本文引用格式

ZHOU Qi-yang , WANG Nan , CHEN Xiu-fa . 测定癌胚抗原的吖啶酯化学发光免疫分析方法的建立[J]. 标记免疫分析与临床, 2013 , 20(6) : 451 -454 . DOI: 10.11748/bjmy.issn.1006-1703.2013.06.026

Abstract

Abstract: Objective To establish a quantitative detection method for determination of serum carcinoembryonicantigen levels. Methods Based on the principle of double antibody sandwich method, the acridinium ester chemiluminescence immunoassay was developed by using bridged avidin-biotin technique. Results The lowest detection limit of assay was 0.2 ng/mL. The linear range was 2.2360 ng/mL and batch variation was 1.9%2.2%. The total variance was 6.5%8.1%. The test results by this assay and ROCHE varcinoembryonic antigen assay Kit were linear correlation (Y=0.9969X+0.6168, r=0.9921). Conclusion The assay developed in this study might meet the requirements of clinical test and are suitable for clinical application.

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