化学发光免疫项目标准化实践与挑战.pdfVIP

化学发光免疫项目标准化实践与挑战 Key Points 化学发光（CLIA ）概述 标准化常见问题 典型标准化案例介绍 小结 2 © 2016 Mindray Confidential The History and Foundation of Immunoassay 1950s Rosalyn Yalow 1970s 1980s 1990-2000s Created RIA RIA widely used ELISA ELISA to CLIA  Chemistry of the antigen-antibody reaction  Specificity and recognition sites Fab  Contribution of binding forces Fab  Affinity and kinetics  Spatial orientation of critical molecules  Optimize for assay format Rosalyn Yalow  Definition of epitopes and paratope regions 1 9 7 7 N o b e l Fc  Structural design p r i z e 3 © 2016 Mindray Confidential Why immunoassay? Easy, stable, sensitive, specific, matured technology Relatively easy and cheap to use Manual or automation with high throughput Good for large sample numbers Qualitative as well as quantitative Expanding menu 4 © 2016 Mindray Confidential J He