LAg-Avidity EIA法用于HIV-1新发感染检测的性能评价研究

发布时间：2018-03-27 21:04

本文选题：艾滋病病毒　切入点：限制性抗原亲和力法　出处：《现代预防医学》2016年01期

【摘要】：目的评价LAg-Avidity EIA法用于HIV-1新发感染检测的性能。方法应用LAg-Avidity EIA法检测617份HIV-1阳性样本(包括123份接受抗病毒治疗的艾滋病晚期病人样本和494份2014年江西省新报告HIV-1感染者样本),比较试剂盒中阴性质控品(NC)、校准品(CAL)、弱阳性质控品(LPC)和强阳性质控品(HPC)的OD值和OD(n)值的平均值、标准差和变异系数,比较144份样本的初筛试验和确认试验结果的一致性,计算LAg-Avidity EIA法对于抗病毒治疗感染样本的误判率。结果 16块酶标板的阴性质控品、校准品、弱阳性质控品和强阳性质控品OD值的变异系数在5%~19%之间,经校准品校准后阴性质控品、弱阳性质控品和强阳性质控品OD-n值的变异系数继续减小至7%之内;144份样本初筛试验和确认试验OD-n值相关系数R2=0.95;LAg-Avidity EIA法将123份接受抗病毒治疗的艾滋病晚期病人样本中的19份误判为近期感染,误判率为15.45%(19/123)。结论 LAg-Avidity EIA法检测稳定性和重复性均较好,可以广泛用于HIV-1新发感染检测,但是进行新发感染检测前需剔除抗病毒治疗样本。
[Abstract]:Objective to evaluate the performance of LAg-Avidity EIA method in the detection of new HIV-1 infections. Methods 617 HIV-1 positive samples (including 123 Aids patients receiving antiviral therapy and 494 new HIV-1 reports in Jiangxi Province in 2014) were detected by LAg-Avidity EIA method. The mean values of OD and ODN values of negative quality control products, calibration products, weak positive quality control products and strong positive quality control products were compared. Standard deviation and coefficient of variation were compared. The results of screening test and confirmation test were compared, and the misjudgment rate of LAg-Avidity EIA method for antiviral treatment of infected samples was calculated. The coefficient of variation of OD value of weak positive quality control and strong positive quality control is between 5% and 19%. After calibrating, the negative quality control is negative. The coefficient of variation of OD-n value of weakly positive quality control and strong positive quality control continued to decrease to within 7% of 144 samples. The correlation coefficient of OD-n value between primary screening test and confirmation test was R20.95% LAg-Avidity EIA method. 123 samples of advanced AIDS patients receiving anti-viral therapy were collected by the method of LAg-Avidity EIA. Nineteen of them were misjudged to be recent infections. Conclusion LAg-Avidity EIA method has good stability and reproducibility, and can be widely used in the detection of new infection of HIV-1, but antiviral treatment samples should be removed before the detection of new infection.
【作者单位】：江西省疾病预防控制中心;
【分类号】：R512.91

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