ADDCARE1100全自动酶免分析仪测定血清HIV抗体应用评价  

Application evaluation of ADDCARE 1100 fully automatic enzyme immunoassay analyzer detecting serum HIV antibody

作　　者：张蓉[1] 周爱凤[1] 张葆康 牛爱荣[1] 

机构地区：[1]青岛大学医学院第二附属医院检验科,山东青岛266042

出　　处：《医学检验与临床》2016年第1期25-27,共3页Medical Laboratory Science and Clinics

摘　　要：目的：对ADDCARE1100全自动酶免分析仪测定血清HIV抗体的性能进行评价。方法：参考NCCLSEP5文件及有关文献。分别用零点漂移、加样精度、洗板残液量、不精密度、正确度等试验对仪器相关性能进行评价。结果：ADDCARE1100全自动酶免分析仪零点漂移为士0．002，加样精度变异系数为0．418％，洗板残液量平均每孔为0．0167～0．05。不精密度CV值分别为Swr：9．96％；Srr：10．53％；Sdd：0．45％；ST：11．88％。结论：本单位ADDCARE1100全自动酶免分析仪性能可靠、操作简单：本实验室高通量ELISA法测定血清HIV抗体在不精密度、正确度等方面的性能能够满足，临床的需要。Objective ： To evaluate the function of ADDCARE 1100 automatic enzyme immunoassay of the determination of serum HIV. Methods ： Reference to NCCLS EP5 and relative literature, the relative performance were evaluated with zero drift test, sampling precision, postwashing residual test, nonpreeision test and veracity test.Results ： The zero drift is -~r 0.002; the CV of the sampling precision is 0.418% ; the postwashing residual is 0.0167 ~ 0.05 per well averagely. The CV of nonpreeision is Swr 9.96%, Srr 10.53%, Sdd 0.45%, and ST 11.88%. Conclusions ： After appropriate adjustments, the sampling, washing and reading systems of ADDCARE 1100 automatie enzyme immunoassay instrument are credible and easy to operation ; The analytical performance of the determination of serum HIV in terms of nonpreeision and veracity can all meet the requirem ents of clinical specifications.

关 键 词：高通量ELISA 性能评价 HIV 

分 类 号：R446[医药卫生—诊断学]