应用ELISA法检测门冬酰胺酶中残余大肠杆菌菌体蛋白含量的研究

采用Cygnus公司"大肠杆菌菌体残留蛋白检测试剂盒"检测门冬酰胺酶中残余宿主菌菌体蛋白含量,建立门冬酰胺酶中宿主菌菌体蛋白残留检测方法并进行了相关方法验证。验证结果表明:宿主菌菌体蛋白浓度在0～100 ng/mL范围内呈良好的线性关系,线性相关系数大于0.99,不同实验人员测得的精密度RSD均小于5%,平均回收率为94.34%。通过对8批门冬酰胺酶样品的检测,测得门冬酰胺酶中的残余宿主菌体蛋白含量均小于550×10-6。该方法具有快速,操作安全简便等优点,灵敏度高,重现性好,可用于门冬酰胺酶的宿主菌体蛋白的残留检测。

Determination of Residual E. coli Protein in Asparaginase by ELISA

The determination method of residual E.coli proteins in Asparaginase was established by using E.coli HCP ELISA kit of Cygnus Technique,Inc.Test results showed that linear relation was obtained in the range of 0 ng/mL ～ 100 ng/mL,and the corre-lation coefficient was above 0.99,precision RSD was both less than 5%.The recovery was 94.34%.Through the eight samples testing,the residual protein of E.coli in Asparaginase was less than 550 × 10-6.The method is fast,safe and easy to operate,so it can be used to detect the residual protein of E.coli in Asparaginase.