探讨简易ELISA定性试剂盒的性能验证方法  

Performance verification of ELISA EB NA1 IgA antibody kit for qualitative detection

作　　者：符俊超[1] 方伟[1] 陆慧琼 FU Junchao;FANG Wei;LU Huiqiong(Laboratory of Guangdong General Hospital guangzhou 510080)

机构地区：[1]广东省人民医院检验科,广州510080

出　　处：《国际检验医学杂志》2019年第A01期141-143,共3页International Journal of Laboratory Medicine

摘　　要：目的通过对EB NA1 IgA抗体试剂盒的性能验证,探讨简易 ELISA定性试剂盒性能验证的方法。方法参照美国临床和实验室标准协会( Clinical and Laboratory Standards Institute,CLSI)批准的 EP15-A2 文件方法来验证ELISA 定性实验的重复性和批内精密度。检出限将灵敏度参考品(临界质控物)重复检测20次,低于临界值的次数不超过1次。符合率取20例已确认的阳性样本和20例已确认的阴性样本,用待评价试剂和对照试剂所得结果进行比较,建立2×2联表统计,符合率大于或者等于95%为验证符合要求。结果手工重复性 CV ≤7.3%,仪器重复性 CV ≤9.5%,手工批内 CV ≤3.0%,仪器批内 CV ≤4.4%,检出限结果是手工法同板OD值低于临界值检测值的次数为1次,仪器法同板OD值低于临界值检测值的次数为0次;不同板均为0次;手工方法符合率为100%,仪器符合率为97.5%。结论本科对EB NA1 IgA试剂盒进行了产品性能验证,其重复性、批内精密性、符合率、检出限方面均通过验证,符合质量目标要求,可用于临床标本检测。Objective Objective to explore the performance verification method of ELISA EB NA1 IgA antibody kit.Methods Refer to the EP15-A2 document approved by the American clinical and Laboratory Standards Association to verify the repeatability and intra precision of ELISA qualitative experiments.detection limit The sensitivity reference material (critical quality control substance) was repeatedly detected 20 times,and the number below the critical value was not more than 1 times.Coincidence rate 20 confirmed positive samples and 20 confirmed negative samples were compared with the results obtained by the reagents to be evaluated and the control reagents.A 2 *2 table was established to verify that the compliance rate was greater than or equal to 95%.Results Manual repeatability of CV is less than 7.3%,repeatability CV is less than 9.5 %,manual CV is less than 3%,and instrument within CV is less than 4.4%.The result of detection limit is that the number of detected values of the same plate OD value below the critical value is 1 times.The number of detected values of the same plate OD value below the critical value was 0 times,The different plates were 0 times.The coincidence rate of manual method was 100%,and the coincidence rate of the instrument was 97.5 %.Conclusion The performance of EB NA1 IgA kit was verified by our department.Its repeatability,precision in batch,coincidence rate and detection limit were all verified and met the requirements of quality target and could be used for clinical specimen detection.

关 键 词：EBNA1IgA抗体试剂盒 酶联免疫吸附试验 性能验证 

分 类 号：R446.61[医药卫生—诊断学]