乙肝表面抗原酶联免疫试剂性能验证  

The verification of the performance of hepatitis B surface antigens by enzyme-linked immunosorbent assay

作　　者：王卫才 

机构地区：[1]陕西省商州区妇幼保健院,陕西西安726000

出　　处：《国外医学（医学地理分册）》2015年第3期227-229,共3页Foreign Medical Sciences：Section of Medgeography

摘　　要：目的对使用的乙肝表面抗原酶联免疫试剂盒性能指标进行验证,为实验室选用合格方法和试剂提供依据。方法评价试剂盒的正确度、重复性、检出限。其中正确度验证采用统计2014年卫计委感染性疾病血清标志物A能力比对结果,要求符合率≥80%;重复性验证采用对临界值-20%、临界值+20%样本进行连续10d检测,要求一致性≥95%:通过对临界值附近不同浓度样本的检测,获得阳性率≥95%的最低浓度作为检出限的确认标准。结果2014年卫计委感染性疾病血清标志物A能力比对,本院乙肝表面抗原符合率为100%;对临界值-20%、临界值+20%样本10d20次检测,一致性分别为95%、100%;在对0.68IU/mL乙肝表面抗原标准物质检测中,阳性率为100%。结论北京万泰公司乙肝表面抗原酶联免疫试剂盒正确度、重复性能满足本院质量目标要求,在使用奥斯邦(AusBio-STAR、Fame)全自动酶标分析仪时检出限为0.68IU/mL。Objective To verify the performance of hepatitis B surface antigens by enzyme‐linked immunosorbent kit ,and to provide the basis for laboratory selection qualified reagent .Methods The accuracy , reproducibility and detection limit of the kit were evaluated .The accuracy was verified by the Statistic results of the proficiency testing of infection diseases A serum markers of National Health and Family Planning Commission of the People＇s Republic of China in 2014 ,and the consistency was required to be ≥80% .The samples of cut‐off‐20% and cut - off ＋ 20% were detected separately in 10 consecutive days for the reproducibility verification , and the consistency was required to be ≥95% .Through detection of samples with different concentrations near cut -off , the lowest concentration which positive rate ≥ 95% was recognized as the detection limit . Results The consistency of hepatitis B surface antigens was 100% .The consistency of cut-off-20% and cut-off＋20% as 95%and 100% ,respectively .When the 0 .68 IU/mL hepatitis B surface antigen standard substance was detected ,the positive rate was 100% .Conclusion The accuracy ,reproducibility of the hepatitis B surface antigen ELISA kit meets the quality objectives .With AusBio‐STAR ,Fame ,the detection limit of the kit was 0 .68 IU/mL .

关 键 词：乙肝表面抗原 酶联免疫 正确度 重复性 检出限 

分 类 号：R512[医药卫生—内科学]