梅毒非特异性抗体检测试剂国家参考品的研制  

Development of national reference panel for detection kit for non-specific Treponema pallidum antibody

作　　者：夏德菊 王薇 许四宏[1] 周海卫[1] 张春涛[1] XIA De-ju;WANG Wei;XU Si-hong;ZHOU Hai-wei;ZHANG Chun-tao(Division II of Diagnositic for Infectious Diseases,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂二室

出　　处：《中国生物制品学杂志》2019年第11期1247-1251,1256,共6页Chinese Journal of Biologicals

基　　金：国家突发急性传染病诊断试剂参考品及评价技术研究(2018ZX10102001)

摘　　要：目的建立梅毒非特异性抗体检测试剂国家参考品。方法通过对84份血浆的复核、确证,组建梅毒非特异性抗体检测试剂国家参考品,并将3份效价检测用参考品溯源至国际标准品,经5家实验室的协助标定,确定参考品的质量标准,并对参考品进行均匀性及稳定性评估。结果梅毒非特异性抗体检测试剂国家参考品由25份阴性及25份阳性样品组成,3份效价检测用参考品的效价定值分别为12、10和5 IU/mL。协助标定确证25份阴性参考品均为阴性,25份阳性参考品均为阳性,效价参考品的效价检测值均≤0.625 IU/mL。参考品的均匀性及稳定性均符合要求。结论研制的参考品可作为梅毒非特异性抗体检测试剂的质量控制和评价使用。Objective To develop the national reference panel for detection kit for non-specific Treponema pallidum antibody.Methods By reviewing and confirming 84 positive and negative samples of the candidate,the reference panel was composed,and the three references for potency tests were traced back to the international standard.The quality standard of the reference was determined by the collaborative calibration of five laboratories.The developed reference panel was evaluated for uniformity and stability.Results The national reference panel consisted of 25 negative and 25 positive samples,and the potencies of the three reference products for potency test were 12,10,and 5 IU/mL respectively.Cooperative calibration proved that all the test results of 25 negative references were negative,while those of 25 positive references were positive,and the potencies of multivalent references for potency test were not more than 0.625 IU/mL.Both the uniformity and stability of the reference panel met the relevant requirements.Conclusion The developed reference may be used for the quality control and evaluation of detection kit for non-specific Treponema pallidum antibody.

关 键 词：梅毒 非特异性抗体检测试剂 国家参考品 

分 类 号：R447[医药卫生—诊断学]