抗环瓜氨酸肽抗体 抗角蛋白抗体 抗核周因子自制质量控制品的制备及评价  

Preparation and evaluation of quality control products made by ourselves against rheumatoid arthritis

作　　者：黄蓉 陈素峰[3] 马筱玲[1] Huang Rong;Chen Sufeng;Ma Xiaoling(Department of Laboratory Medicine,Anhui Provincial Hospital,Anhui Medical University,Hefei 230001,China;Department of Laboratory Medivine,Yuhuan People's Hospital,Taizhou 317600,China;Department of Laboratory Medicine,the People's Hospital of Zhejiang Province,Hangzhou 310014,China)

机构地区：[1]安徽医科大学安徽省立医院检验科,合肥230001 [2]浙江省玉环市人民医院检验科,317600 [3]浙江省人民医院检验科,杭州310014

出　　处：《中华风湿病学杂志》2020年第11期731-735,共5页Chinese Journal of Rheumatology

基　　金：浙江省基础公益研究计划项目资助(LGF20H080005)。

摘　　要：目的探讨实验室抗CCP、AKA、APF这3种自身抗体自制质控品的制备及评价,为其他自身抗体自制质控品的制备提供参考。方法将阳性血清和体检健康人群的阴性血清按比例进行混合,调制成所需浓度的混合血清,再进行56℃加热30 min灭活,离心过滤后分装,置-20℃以下冰箱保存。检测20瓶质控品以及连续检测20次同瓶质控品计算变异系数(CV)值来测定混合血清的瓶间差。37℃水浴储存条件下每天检测10次求出偏差,来判断37℃条件下的稳定性。-20℃冷冻储存,每周检测1次,求出每月CV值,来判断长期稳定性。结果37℃条件下,在长达8 d的时间中,抗CCP抗体的偏倚都小于±20%的偏倚要求,AKA、APF的结果都在上下一个滴度的可接受范围内。在瓶间差测试中,抗CCP抗体的CV瓶间为3.2%,远<20%的瓶间差要求,而AKA、APF的瓶间差可视为0。在-20℃长期稳定性实验中,累计9个月的检测结果,抗CCP抗体总CV为10.6%,<20%的要求,AKA、APF结果都在上下一个滴度的可接受范围内。所有阴性质控品的检测结果均为阴性。结论抗CCP、AKA、APF这3种抗体自制混合血清质控品的性能良好,且该方法简单,可操作性强,适用于各级医院和实验室,也为其他自身抗体室内质控品的制备提供参考。Objective To study the preparation and evaluation of quality control products made by ourselver for anti-cyclic citrullinated peptide(CCP)antibody,anti-keratin anti-body(AKA)and anti-perinuclear factor(APF)in laboratory,and to provide reference for the preparation of other quality control products made by ourselver.Methods The positive serum was mixed with the negative serum at a certain proportion,then inactivated at 56℃for 30 minutes,then aliquoted after filtration and centrifugation,stored in refrigerator below-20℃.Test 20 bottles of quality control products and continuously tested the same bottle of quality control products 20 times to calculate the Coefficient of Variation(CV)value to determine the inter-bottle variation.Under 37℃water bath storage,the bottle were tested 10 times a day to determine the deviation in order to judge the stability at 37℃.Frozen storage at-20℃,then tested once a week in order to determine the value of monthly CV to judge the long-term stability.Results Under the condition of 37℃,for up to 8 days,the deviation of anti-CCP antibody was less than±20%,and the titer of AKA and APF were within the acceptable range.In the inter-bottle variations test,the CV inter-bottle variations of anti-CCP antibody was 3.2%,which was far less than the inter-bottle variations requirement of 20%,while the inter-bottle variations of AKA and APF could be regarded as 0.In the long-term stability test of-20℃,the total CV of anti-CCP antibody was 10.6%,less than 20%,and the titer of AKA,APF were all within the acceptable range.All test results for negative quality control products were negative.Conclusion The mixed serum quality control products of anti-CCP,AKA,APF antibodies made by ourselves have good performance,and the method is simple and maneuverable,which is applicable to hospitals and laboratories at all levels.It can also provide reference for the preparation of indoor quality control products of other autoantibodies.

关 键 词：关节炎 类风湿 自身抗体 质量控制品 

分 类 号：R593.2[医药卫生—内科学]