摘要
双抗体夹心一步法建立人C肽（C-peptide）化学发光免疫分析（CLIA）方法。方法可测范围0．15-15ng／mL，灵敏度0．02ng／mL，批内、批间变异系数（CV）分别为4．2％-6．5％和6．8％-9．3％，与胰岛素无交叉反应，与胰岛素原的交叉反应率为7．3％。本方法与国外同类试剂盒同时检测40份C-肽释放试验血清，相关系数为0．9709。本方法各项指标均满足临床检测要求，达到国外同类产品水平。
To develop a chemiluminescent immunoassay assay （CLIA） for detection of human C-peptide by one-step sandwich method. The detection range of C-peptide with developed CLIA was from 0.15 to 15 ng/mL. The sensitivity of developed C-peptide CLIA was 0.02 ng/mL. The intra- and inter-assay coefficients of variation were 4.2% to 6.5% and 6.8% to 9.3% respectively. There was no cross-reaction with insulin and the cross-reactivity rate with proinsulin was 7.3 %. The correlation coefficient for the detection results of 40 blood samples （ Oral Glucose Tolerance Test） between home-made and foreign commercially available C-peptide kit was 0. 9709. The developed C-peptide CLIA in this study was suitable for clinical application with high sensitivity, specificity and accuracy.
出处
《标记免疫分析与临床》
CAS
2008年第6期386-389,共4页
Labeled Immunoassays and Clinical Medicine
基金
科技部中小型企业技术创新基金资助项目(04C26221100313)
关键词
C肽
化学发光免疫分析
释放参考值
糖尿病
C-peptide
Chemiluminescent immunoassay
Tolerance expected value
Diabetes
