高通量ELISA测定血清癌胚抗原的应用评价  

AN EVALUATION OF HIGH-THROUGHPUT ELISA IN DETERMINATION OF SERUM CARCINOEMBRYONIC ANTIGEN

作　　者：周爱凤[1] 赵自云[1] 陈娟[1] 牟晓峰[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：《青岛大学医学院学报》2015年第6期659-661,共3页Acta Academiae Medicinae Qingdao Universitatis

基　　金：卫生部医药卫生科技发展研究中心专项课题(28-2-8);山东省医药卫生科技发展计划项目(2013WS0016)

摘　　要：目的对ADDCARE 1100全自动酶免分析仪的性能进行评价,为ADDCARE 1100高通量酶联免疫吸附试验（ELISA）检测血清癌胚抗原（CEA）的标准化、系统化寻求解决方案。方法参考NCCLS EP5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、正确度等实验对仪器的加样系统、洗板系统和读数系统进行评价,并对CEA检测曲线拟合方式的选择、洗板方法以及参考范围进行初步探索。结果 ADDCARE 1100全自动酶免分析仪的零点漂移为-0.002～0.002,加样精度变异系数为0.468%,洗板残液量平均每孔为0.012 5～0.062 5μL。高、中、低浓度样本不精密度变异系数：批内标准差（swr）为4.7%、3.6%、5.0%,批间标准差（srr）为3.5%、2.9%、4.7%,天间标准差（sdd）为2.1%、2.7%、4.6%,总标准差（sT）为4.2%、3.3%、5.8%。结论本单位ADDCARE 1100全自动酶免分析仪经相应调整后,加样系统、洗板系统、读数系统性能可靠、操作简单,能够满足实验室高通量ELISA测定全程自动化的需要。Objective By evaluating the function of ADDCARE 1100 automatic enzyme immunoassay analyzer,to seek solutions for standardized and systematic detection of serum carcinoembryonic antigen（CEA）with this device. Methods Referring to NCCLS EP5 and related literature,the sampling system,washing system and reading system of ADDCARE 1100 were evaluated with zero drift test,sampling precision,postwashing residual test,nonprecision test and veracity test.The way of fitting method of the detection curve of CEA,the way of washing and the reference range were preliminarily explored. Results The zero drift of the device was-0.002-0.002;the CV of the sampling precision was 0.468%;the postwashing residual was 0.012 5-0.062 5μL per well averagely.The CV of non-precision of the high,middle and low concentrations were swr4.7%,3.6%,5.0%;srr3.5%,2.9%,4.7%;sdd2.1%,2.7%,4.6%and sT4.2%,3.3%,5.8%. Conclusion After a corresponding adjustment,the sampling,washing and reading systems of ADDCARE 1100 automatic enzyme immunoassay analyzer were credible and easy to operate,which meets the demand for whole-range automatization of ELISA in a clinical laboratory.

关 键 词：酶联免疫吸附测定 癌胚抗原 评价研究 参考标准 

分 类 号：R730.43[医药卫生—肿瘤]