| C-肽时间分辨荧光免疫分析试剂盒的研制 |
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| 引用本文： | 刘忠民,张婷,冯健明,郑贵星.C-肽时间分辨荧光免疫分析试剂盒的研制[J].上海医学检验杂志,2009(7). |
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| 作者姓名： | 刘忠民 张婷 冯健明 郑贵星 |
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| 作者单位： | 广州医学院医学检验系;广州丰华生物工程有限公司; |
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| 基金项目： | 广州市科技攻关项目(2005Z3-E0591) |
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| 摘 要： | 目的研制血清C-肽的时间分辨荧光免疫分析(TRFIA)试剂盒。方法采用双抗体夹心法建立C-肽TRFIA试剂盒,并进行方法学评价。结果C-肽可测量范围为0.4~20 ng/mL;分析敏感性为0.23 ng/mL;分析批内、批间精密度分别为7.99%、11.97%;C-肽回收率为99.57%;与胰岛素和胰岛素原无交叉反应。稳定性试验表明,试剂可以贮存在4℃稳定9个月,37℃稳定7 d;该试剂盒测试200份正常人血清样本,其参考范围为0.358~3.590 ng/mL;收集122份血清样本,用该试剂盒与国外其他方法的同类试剂盒同时检测,其相关系数为0.9432,线性方程为Y=0.9854X+0.5063。结论C-肽TRFIA试剂盒各项指标均达到临床检测要求,适合临床推广使用。
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| 关 键 词： | 时间分辨荧光免疫分析 C-肽 方法学评价 |
Development of a time-resolved fluoroimmunoassay kit for detecting C-peptide |
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| LIU Zhongmin,ZHANG Ting,FENG Jianming,ZHENG Guixing.Development of a time-resolved fluoroimmunoassay kit for detecting C-peptide[J].Shanghai Journal of Medical Laboratory Sciences,2009(7). |
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| Authors: | LIU Zhongmin ZHANG Ting FENG Jianming ZHENG Guixing |
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| Institution: | 1.Department of Laboratory;Guangzhou Medical College;Guangdong Guangzhou 510260;China;2.Guangzhou Fenghua Bioengineering Company Limited;Guangdong Guangzhou 510730;China |
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| Abstract: | Objective To develop a time-resolved fluoroimmunoassay(TRFIA) kit for detection of C-peptide in serum.Methods Two anti-C-peptide monoclonal antibodies were used to develop the sandwich TRFIA kit for detection of C-peptide in serum and its methodology was evaluated.Results The detection range of C-peptide was 0.4-20 ng/mL.The analytical sensitivity was 0.23 ng/mL.The intra-assay and inter-assay coefficients of variation were 7.99% and 11.97% respectively.The recovery rate was 99.57%.There was no cross-reacti... |
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| Keywords: | Time-resolved fluoroimmunoassay C-peptide Methodology evaluation |
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