摘要
目的建立1种基于表面等离子共振技术的用于检测人免疫球蛋白Fc段活性的方法。方法利用FcγRI可以与IgG的Fc段发生结合的特性,通过表面等离子共振技术检测样品亲和力常数,其Fc段活性为样品KD与标准品KD比值。方法进行特异性/专属性、精密度、耐用性验证。采用该方法与药典方法共同检测30份人免疫球蛋白Fc段活性,检测结果进行相关性和一致性分析。结果方法学验证结果显示,本方法的特异性/专属性强(t值分别为0.15、0.22,均为P>0.05),精密度好(CV值为5.37%~10.69%),耐用性好(CV值为10.06%),本方法与药典方法检测结果的相关性(r=0.96,P<0.05)和一致性高(偏差值为-2.060,95%置信区间为-5.628~1.508)。结论成功建立了1种基于表面等离子共振技术的用于检测人免疫球蛋白Fc段活性的方法。
Objective To establish a method for detecting human immunoglobulin Fc function based on surface plasmon resonance technology.Methods Based on the characteristic that FcγRI can be binded to the Fc segment of IgG,the affinity constant of the sample was detected by surface plasmon resonance,and its Fc function was the KD ratio of the sample to the standard.The method was validated for specificity/specificity,precision and robustness.The method and the pharmacopoeia method were used to detect the Fc function of 30 human immunoglobulins,and the correlation and consistency of the detection results were analyzed.Results The method validation results showed that this method has strong specificity/specificity(t values were 0.15,0.22,both P>0.05),good precision(CV value 5.37%~10.69%)and good robustness(CV value 10.06%).The detection results of this method and the pharmacopoeia method have high correlation(r=0.96,P<0.05)and high consistency(Bias-2.060,95%Limits of Agreement-5.628~1.508).Conclusion A method for detecting human immunoglobulin Fc function based on surface plasmon resonance has been successfully established.
作者
董方玉
周久越
陈晨
周安
宋佃卫
高建锋
陈曦
李晓
吴嘉伟
杜加诚
周波
菅长永
DONG Fangyu;ZHOU Jiuyue;CHEN Chen;ZHOU An;SONG Dianwei;GAO Jianfeng;CHEN Xi;LI Xiao;WU Jiawei;DU Jiacheng;ZHOU Bo;JIAN Changyong(Taibang Biologic Group,Taian 271000,China;Cytivalifescience Co)
出处
《中国输血杂志》
CAS
2022年第4期396-399,共4页
Chinese Journal of Blood Transfusion
基金
山东省重点研发计划(2019TSLH0408)。
