免疫固定电泳检测室内质量控制样品的研制和评价  

Development and evaluation of internal quality control materials for immunofixation electrophoresis

作　　者：安崇文[1] 陈剑[1] 逄璐 许冬[1] AN Chongwen;CHEN Jian;PANG Lu;XU Dong(Department of Clinical Laboratory,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院检验科,北京100034

出　　处：《检验医学》2024年第1期37-42,共6页Laboratory Medicine

摘　　要：目的 制备适用于琼脂糖凝胶免疫固定电泳(IFE)检测的室内质量控制样品,并对其均匀性、稳定性、适用性进行评价。方法 依据实验室内部研制质量控制样品相关指南要求,基于临床样本,自制琼脂糖凝胶IFE检测阴性、弱阳性、阳性质控品,并对其进行均匀性、稳定性和适用性评价。结果 3个浓度水平质控品的均匀性良好。质控品开瓶后,2~8℃冷藏保存4个月,检测结果一致性较好;不启封-40℃冰箱冻存5年,检测结果一致性较好;同品牌其他系列检测系统和不同品牌检测系统检测结果一致性也较好。结论 制备的琼脂糖凝胶IFE检测室内质量质控样品具有良好的均匀性、稳定性、适用性,可满足临床实验室质量控制要求。Objective To prepare internal quality control materials for agarose gel immunofixation electrophoresis(IFE),and to evaluate its homogeneity,stability and applicability.Methods Clinical samples were selected according to the related guidance for internal quality control materials.The negative,weak positive and positive quality control materials were made.The homogeneity,stability and applicability were evaluated.Results The homogeneity of quality control materials at 3 levels was good.The quality control materials were stored at 2-8℃after opening for 4 months,and the stability was good.The quality control materials at-40℃without opening had good consistency within 5 years.It had been used in other determination systems of the same brand and different determination systems of different brands,and the results were consistent.Conclusions The internal quality control materials for agarose gel IFE has good homogeneity,stability and applicability,which can meet the quality control requirements of clinical laboratories.

关 键 词：免疫固定电泳 室内质量控制 质控品 均匀性 稳定性 适用性 

分 类 号：R446.61[医药卫生—诊断学]