Abstract:Objective Referance products were developed for assay kit of IgG of poliomyelitis to make it possible to reliably control quality of the assay kits in evaluating their properties. Methods Serum was confirmed through a neutralization test to obtain the serum which met requirements. Twenty-two samples were collected for each type of reference products, including 10 positive reference products, 10 negative ones, 1 reference product with the minimum detection limit and 1 precise reference product. Results The conformity ratio of type Ⅰ, Ⅱ and Ⅲ negative reference products of IgG of poliomyelitis was not below 9/10. The conformity ratio of positive reference products was not lower than 8/10, the coefficient of variation of precise reference was not higher than 15%, and the coefficient of variation of precise reference products was not lower than 1/8. The reference products were placed at 37℃ for 5 days. They were still quite stable after 5 repetitive freezing and thawing. Conclusion The prepared reference products of assay kit for IgG of poliomyelitis were tested to be qualified in all tests and could be used for quality control over such assay kits.
谭振国 杨蓉 罗芳宇 谢忠平 李华 谢天宏 尹晓晓 龙润乡▲. 脊髓灰质炎IgG抗体检测试剂参考品的制备及标定[J]. 中国医药导报, 2018, 15(25): 21-24.
TAN Zhenguo YANG Rong LUO Fangyu XIE Zhongping LI Hua XIE Tianhong YIN Xiaoxiao LONG Runxiang▲. Preparation and characterization of reference products for assay kit of IgG of poliomyelitis. 中国医药导报, 2018, 15(25): 21-24.