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ELISA法检测食蟹猴血浆中rhCNB多肽的方法学评价 预览 被引量:4

Methodological evaluation of rhCNB in long-tailed macaque sera detected by Enzyme-linked Immunosorbent Assay(ELISA)
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摘要 目的:酶联免疫吸附法(ELISA)定量测定食蟹猴血浆中rhCNB多肽的方法学评价。方法:利用双抗体夹心ELISA法,对rhCNB多肽的方法学灵敏度、线性范围、精密度与准确度和回收率进行方法学验证。结果:该方法特异性高,在0.195-12.5 ng/ml的线性范围内,线性关系良好,标准曲线方程为Y=15.1X-0.26,R^2=0.996 8,定量下限(LLOQ)为0.195 ng/ml;该方法的批内精密度CV分别为3.55%、1.39%和4.71%;批间精密度CV分别为1.59%、3.2%和3.8%,均〈5%,准确度在91.9%-108.8%之间,方法回收率在88.5%-108.3%之间,〈110%,说明该ELISA方法的准确度较高。符合验证要求。结论:双抗体夹心ELISA法灵敏度高、通量大、重复性、准确度及精密度好,可用于生物样品中rhCNB多肽的定量检测。 Objective: To validate an enzyme linked immunosorbent assay( ELISA) method for the quantification of rhCNB in long-tailed macaque sera. Methods: The linear,sensitivity,accuracy,precision and recovery were determined using ELISA. Results:The present ELISA method had high linearity within 0. 195 ng / ml- 12. 5 ng / ml,the working curve of rhCNB was Y = 15. 1X- 0. 26,R^2= 0. 996 8,the method showed good sensitivity of 0. 195 ng / ml,the accuracy were in the range of 91. 9%- 108. 8%,and the Coefficient of variation( CV) for inter-assay were 3. 55%,1. 39% and 4. 71%,the intra-assay were 1. 59%,3. 2% and 3. 8%,all less than10%,the recoveries were in the range of 88. 5%- 108. 3%, 〈110%. Thus the method was coincidence with requirement. Conclusion: Double antibody sandwich ELISA assay of rh CNB in long-tailed macaque sera has good sensitivity,accuracy,precision and recovery and it can be used to measure rhCNB concentration in biological samples.
作者 邵继平 张彩云 胡不为 谢学立 田树红 王日超 黄道隆 符健 SHAO Ji-Ping ,ZHANG Cai-Yun ,HU Bu-Wei ,XIE Xue-Li , TIAN Shu-Hong , WANG Ri-Chao ,HUANG Dao-Long , FU Jian( Hainan Medical University, Haikou 571199, China)
出处 《中国免疫学杂志》 CAS CSCD 北大核心 2016年第4期528-531,共4页 Chinese Journal of Immunology
基金 国家自然科学基金资助项目(81160408).
关键词 酶联免疫吸附法 食蟹猴 rhCNB多肽 方法学评价 Enzyme linked immunosorbent assay(ELISA) Long-tailed macaque Recombinant human calcineurin B subunit(rhCNB) Methodological evaluation
作者简介 邵继平(1971年-),女,博士,副教授,主要从事新药安全性评价的研究,E-mail:jpshaosl@163.com. 通讯作者及指导教师:符健(1959年-),男,博士,教授,主任,主要从事新药安全性评价的研究。
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  • 1高锦,赵文军,王艳丽,刘一群,魏群.注射用重组人钙调磷酸酶B亚基稳定性的初步研究[J].中国新药杂志,2008,17(8):675-678. 被引量:4
  • 2杨有业,张秀明.临床检验方法学评价[M].北京:人民卫生出版社,2008:118-127. 被引量:180
  • 3中国生物制品标准化委员会编..中国生物制品规程[M].北京:化学工业出版社,2000:710.
  • 4沈关心.现代免疫学实验技术[M].武汉:湖北科学技术出版社.2001,505. 被引量:9
  • 5Savino E, Hu B, SellersJ, et al. Development of an In-House, Process-Specific ELISA for Detecting HCP in a Therapeutic Antibody ,Part 2[J]. Bio Process International ,2011 ,9 :68-75. 被引量:1
  • 6Huisman H, Wynveen P, Nichkova M, et al. Novel ELISAs for screening of the biogenic a mines GABA, glycine, beta?phenylethyla mine, agmatine, and taurine using one derivatization procedure of whole urine samples[J]. Anal Chern, 20 lOb, 82 : 6526-6533. 被引量:1
  • 7F engqiang Wang, Dennis Driscoll, Daisy Richardson, et al. The comparison of chemilu minescent and colorimetric-detection based ELISA for chinese hamster ovary host cell proteins quantification in biotherapeutics[J].J Bioproces Biotechniq, 2013, 3(2) :1000136. 被引量:1
  • 8Nichkova M, Huisman H, Wynveen P, et al. Evaluation of a novel ELISA for serotonin: urinary serotonin as potential biomarker for depression[J]. Anal Bioanal Chem,2012 ,402: 1593-1600. 被引量:1
  • 9Nichkova M, Wynveen PM ,Marc DT ,et al. Validation of an ELISA for urinary dopa mine: applications in monitoring treatment of dopa mine-related disorders[J].J Neurochem,2013 ,125 :724-735. 被引量:1
  • 10Schenauer MR, Flynn GC, Goetze AM. Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry[J]. Anal Biochem,2012 ,428: 150-157. 被引量:1

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