【摘要】 目的对BED捕获酶免疫实验(BED capture enzyme immunoassay,BED-CEIA)的重复性和稳定性进行评价。方法对在国家艾滋病参比实验室(参比室)和A、B两个艾滋病确证中心实验室,使用BED-CEIA方法对新近感染检测的实验数据进行统计。分别对在参比室和A、B两实验室进行检测的59、35和18块酶标板的质控品(NC、CAL、LPC和HPC)OD和OD-n的Mean、SD和C V进行统计。对3个实验室初筛和确认实验结果的一致性进行比较,得出R2值。使用同一考核血清盘,将11位不同实验人员的实验结果与参比室实验员的实验结果进行比较,得出R2值。结果在参比室进行的实验中,对OD-n的统计显示,质控品NC的C V为14.4%,LPC和HPC的C V值约为5%;在A实验室中,LPC和HPC的C V值均控制在10%以内;在B实验室中,LPC和HPC的C V值均控制在12%以内。3个实验室初筛和确认实验结果的R2值均达到了0.90以上。其他实验人员与参比室实验人员的结果实验比较显示,R2为0.9777,不同实验员之间可重复性强。结论BED-CEIA方法的稳定性和重复性均十分突出,可以在我国接受过专项培训的艾滋病确证中心实验室开展该项工作。更多还原

【Abstract】 Objective To evaluate the performance of BED-CEIA(BED capture enzyme immunoassay)in terms of its reproducibility and stability.Methods Experimental data(OD of 59.35 and 18 plates,mean,SD and CV of OD-n)derived separately from the national AIDS reference laboratory(NARL)and HIV confirmatory laboratory A and B in detecting recent HIV infection by BED-CEIA were statistically analyzed.The consistency of the initial and confirmatory data derived from these three laboratories were compared,while the data obtained from 11 laboratory technicians were compared with those from NARL technicians by using the same serum panel;and R2 was taken as the the final value.Results In NARL,the OD-n CV of NC was generally 14.4%,and OD-n CV of LPC and HPC was about 5%.In laboratory A,the OD-n CV of LPC and HPC was less than 10%.In laboratory B,the OD-n CV of LPC and HPC was less than 12%.The level of consistency between the technicians from NARL and other laboratories was quite high(R2=0.9777),and the correlation coefficient,or R2 between initial and confirmatory tests in these 3 laboratories were all above 0.90.Conclusion The performance of BED-CEIA in terms of its reproducibility and stability is excellent and it can be used as a tool to confirm HIV recent infection in this country.更多还原