两种HIV1新发感染检测方法的性能比较研究.docVIP

两种HIV-1新发感染检测方法的性能比 较研宄 张娜刘丽痤易志强靳廷丽唐翼*工?組垦良 !UB=疾病预防控制中心 !UB= 疾病预防控制中心 目的比较两种11IV-1新发感染检测方法的性能。方法应用BED-CEIA法和 LAg-Avidity EIA法检测457份HIV-1感染荠样本（包括117份己经接受抗病毒 治疗的艾滋病病人样本和2014年部分新报告的H1V-1感染者样本340份），比 较弱阳性质控品（LPC）、强阳性质控品（HPC）、阴性质控品（NC）和校准品 （CAL）的0D值和0D （n）值的标准差、变异系数和平均值，比较确认实验和初 筛实验检测结果的一致性，并且计算两种方法对接受抗病毒治疗的艾滋病病人 样本的误判率。结果16次实验的弱阳性质按品、强阳性质控品、阴性质控品和 校准品0D值的变异系数在25%以内，经校准品校准后强阳性质控品和弱阳性质 控品ODn值的变异系数减小至10%以内。117份接受抗病毒治疗的艾滋病病人样 本，BED-CETA法将其中19份样本误判为新发感染，误判率为16. 23% （19/117） ;LAg-Avidity EIA法将其屮17份样本误判为新发感染，误判率为 14.52% （17/117）。结论BED-CEIA法和LAg-Avidity EIA法检测重复性和稳定 性均较好，LAg-Avidity E1A法的误判率略低于BED-CE1A法的误判率（即特异 性更好），但在检测前均需将抗病毒治疗样木剔出。 关键词： 艾滋病病毒;新发感染;检测性能; 张娜（1982-）,女，硕士，主管检验师，研宄方向:病原学检测 胡国良， : jxcdchgl@163. com 2017-05-30 基金：江西省卫生计生委科技项0 HIV-1 incidence detecting performance of two methods ZHANG Na LIU Li-pin YI Zhi-qiang JIN Ting-li TANG Yi-long DING Chen HU Guo-liang Jiangxi Provincial Center for Disease Control and Prevention; Abstract： Objective To compare the performance of two methods of detecting HIV-1 incidence. Methods HIV-1 positive samples ( 117 long-term infection serum samples with antiretroviral therapy and 340 serum samples of newly reported HIV/AIDS cases in 2014 in Jiangxi province) were tested by BRD-CRTA and LAg-Avidity ETA, then the coefficient of variation, mean and standard deviation of optical density ( 0D) and normalized 0D ( ODn) of 16 individual plates were analyzed for low positive control, high positive control, negative control and calibrate, and the results of confirmatory and initial tests of serum samples were analyzed. Meanwhile, the false-recent rate was calculated. Results The CV of 0D for low positive control, high positive control and calibrator were lower than 25%, then after normalization by the calibrator, the CV of ODN for low positive control and high positive control were reduced to about 10%. The false-recent rate of BED-CEIA was 16. 23% ( 19/117) and the false-recent rate of LAg-Avidity EIA was 14. 52% ( 17/117) ? C