血清抗可提取性核抗原抗体检测质控品的制备及评价  

Preparation and evaluation of quality control of serum anti-extractable nuclear antigen antibody

作　　者：李荣海[1] 张鹏[1] 郭慧娟[1] 高洁[1] 王雅平[1] 刘文娟[1] 尚晓泓[1] 李琦[1] LI Ronghai;ZHANG Peng;GUO Huijuan;GAO Jie;WANG Yaping;LIU Wenjuan;SHANG Xiaohong;LI Qi(Department of Clinical Laboratory,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院检验科,北京100091

出　　处：《国际检验医学杂志》2018年第20期2504-2506,2510,共4页International Journal of Laboratory Medicine

基　　金：国家自然科学基金资助项目(81671618)

摘　　要：目的自制抗可提取性核抗原(ENA)抗体弱阳性及阴性质控品,确保常规检测工作结果的质量。方法将抗核抗体(ANA)谱阳性结果的患者血清置于56℃30min条件下灭活,离心去除沉淀后血清(结果为RNP++,Sm++,SS-A++,SS-B++,dsDNA++)与ANA及ANA谱全部阴性献血员血清按照1∶N比例混匀,配置成ENA弱阳性质控品(结果为RNP±,Sm±,SS-A±,SS-B±,dsDNA±),采用免疫印迹法和酶联免疫吸附法检测ENA弱阳性质控品,然后进行均一性、稳定性、破坏性实验验证。结果均一性、稳定性、破坏性实验验证均通过,ENA阴性质控品所有阴性的靶抗原都能够检测出阴性,所有阳性的靶抗原都能够检测出阳性。结论经过验证,ENA自制质控品符合该科要求,可以应用于常规检测工作。Objective Homemade weakly positive and negative quality control of ENA so as to ensure qual ity work routine testing results. Methods The serum ANA spectrum of positive results （RNP ＋ ＋, Sm＋ ＋, SS A ＋ ＋,SS B ＋ ＋ and dsDNA ＋＋） and ANA and ANA spectrum of all negative serum according to 1 ： N ratio of mixing,arranged ENA weak positive control materials （RNP ＋ ,Sin ＋ ,SS A ＋ ,SS B ＋ and dsD NA ＋）. ENA weak positive control materials was detected by both Western blot and enzyme linked immu nosorbent assay, and then the homogeneity test, stability test and destructive experiments were conducted. Resuits Homogeneity test, stability test and destructive experiments have been verified by experiments. ENA negative quality controls of all the negative target antigens were detected negative and all positive target anti gens were detected positive. Conclusion ENA homemade quality control products is coincide with experimen tal demands, which can be used for the laboratory routine testing.

关 键 词：可提取性核抗原 自制质控品 制备及评价 

分 类 号：R446.6[医药卫生—诊断学]