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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。
Objective To evaluate the performance of the LAg-Avidity EIA method in the detection of new HIV-1 infections. Methods Six hundred and seventy HIV-1 positive samples (including 123 HIV-infected patients receiving ART and 494 HIV-1 newly infected patients in Jiangxi province in 2014) were tested by LAg-Avidity EIA. Negative The mean, standard deviation and coefficient of variation of OD and OD (n) values for NC, CAL, LPC and HPC were compared 144 samples of the screening test and confirm the consistency of the test results to calculate the false positive rate of LAg-Avidity EIA method for antiviral treatment of infected samples. Results The coefficient of variation (OD) of negative control, calibrator, weak positive control and strong positive control of 16 ELISA plates ranged from 5% to 19%. After calibration, the negative control, The coefficient of variation (OD-n) of weakly positive controls and strong positive controls continued to decrease to within 7%; the correlation coefficient of OD-n between 144 screening samples and validation tests was 0.95; LAg-Avidity EIA A total of 123 new HIV / AIDS patients receiving antiretroviral therapy were misidentified as recent infections, with a 15% chance of false positives (19/123). Conclusion LAg-Avidity EIA has good stability and repeatability. It can be widely used in the detection of new HIV-1 infection, but need to remove the anti-virus treatment sample before the new infection is detected.