检测HIV-1新发感染的限制性抗原亲和力方法的重复性与稳定性评价  

Evaluation of the repeatability and stability of limiting-antigen avidity enzyme immunoassay for HIV-1 incidence estimates

作　　者：于海英[1] 叶艺 张娜[1,3] 颜浩[1] 邱茂锋[1] 王宇[4] 蒋岩[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心参比实验室,北京102206 [2]北京金豪制药股份有限公司,北京100176 [3]江西省疾病预防控制中心,南昌330029 [4]中国疾病预防控制中心,北京102206

出　　处：《中国艾滋病性病》2013年第5期318-321,共4页Chinese Journal of Aids & STD

基　　金：国家科技重大专项(No.2012ZX10001-001001002和2013ZX10001001-001-007);北京市重大专项(No.D09050704090905)~~

摘　　要：目的评价检测艾滋病病毒Ⅰ型(HIV-1)新发感染的限制性抗原亲和力酶联免疫试验的重复性、稳定性和准确度,探讨该方法推广应用的可行性。方法采用检测精密度、孔间精密度、批间差、两实验员和两实验室之间结果的相关性,评价试剂的重复性;利用37℃热稳定性试验评价试剂的稳定性;使用国际标准盘评价试剂的准确度。结果检测精密度结果显示,所有样本标化吸光度值(ODn)的变异系数(CV)<15%,两实验员和两实验室试验结果的相关系数R2值均>0.99,孔间精密度CV值最小为3.76%,3个批次试剂的批间差结果显示,25份内控盘样本中,只有1份样本CV值>15%,为22.5%。37℃放置7天与4℃保存的酶结合物和酶联板,对内控盘样本检测的ODn值没有明显区别。国际标准盘评判结果与预期值一致。结论检测HIV-1新发感染的限制性抗原亲和力方法具有较好的稳定性、重复性和准确度,可以在实验室网络中推广应用。Objective To evaluate the repeatability,stability and accuracy of limiting antigen avidity enzyme immunoassay for using in the human immunodeficiency virus（HIV） network laboratories all over the country.Method The repeatability of the assay was evaluated by testing the precision of different runs,wells and lots,and the correlation between two technicians and two laboratories;the stability was evaluated by using 37℃ heat-stability test and the accuracy was assessed by testing the BOCA 101 panel.Results The coefficient of variation（CV） of all 25 specimens of KH-LAg-25A panel was less than 15% by counting the ODn values of eight runs;in case specimens were tested twenty wells,the minimum CV was 3.76%.Only one specimen in KH-LAg-25A panel had a CV of 22.5%,higher than 15%,referring to the ODn results of three lots;the correlation between two laboratories and two technicians was higher than 0.99.The conjugates and plates kept at 37℃ for 7 days had no obviously different results from the 4℃ condition.The BOCA 101 panel had the same results with the US CDC expected outcomes.Conclusion the performance of LAg-avidity EIA in terms of its repeatability,stability and accuracy is excellent and can be used in the HIV network laboratories in the country.

关 键 词：艾滋病病毒 限制性抗原亲和力方法 稳定性 重复性 准确度 

分 类 号：R512.91[医药卫生—内科学]