限制性抗原亲和力法用于HIV-1新发感染筛查的临床研究

Clinical study on the screening of new HIV-1 infections with limiting antigen avidity enzyme immunoassay

目的分析限制性抗原亲和力酶免法(LAg)在用于人类免疫缺陷病毒I型(HIV-I)新发感染筛查时的应用效果。方法收集HIV高危人群新发感染检测样本共计100份,分别应用LAg法和BED捕获酶免法(BED)进行检测。同时采用37℃热稳定性试验,对LAg稳定性进行分析,采用国际标准盘对其准确度进行评定。结果 13份HIV抗体阳性急性感染期病例样本,LAg判定新发11份,BED判定新发12份。65份常规报告病理样本中,LAg判定长期感染48份,BED判定长期感染共计为46份。21份发病期样本检测结果显示,LAg判定长期感染共计17份,BED判定为长期感染为16份。LAg检测HIV-1抗体与BED实验结果差异无统计学意义(P> 0.05)。试剂在37℃状态下和4℃保存状态的ODn值无明显变化,而国际标准盘评价结果也与预期值相一致。结论限制性抗原亲和力法在用于HIV检测时,其检出率和错判率与BED基本接近,但是其受到CD4+T细胞的影响较小,且具有良好的稳定性和准确度,故而更加适宜在临床检验时应用。

Objective It is aimed at analyzing the effect of limiting antigen avidity enzyme immunoassay( LAg-avidity EIA)on the screening of new HIV-I infections. Methods A total of 100 samples were collected for the detection of new infections in high-risk HIV population,and the LAg method and BED capture enzyme free method( BED) were used for the detection respectively. At the same time,the thermal stability test at 37℃ was used to analyze the LAg stability,and the international standard panel was used to evaluate its accuracy. Results In the thirteen samples of HIV-positive patients in the acute stage of infection,11 samples were newly detected for LAg and 12 samples for BED. Among the 65 routine pathological samples,48 were determined as long-term infection by LAg and 46 as long-term infection by BED. The test results of 21 samples at the onset stage showed a total of 17 samples for long-term infection of LAg and 16 samples for long-term infection of BED. There was no statistical significance on the difference between the results of HIV-1 antibody and BED test with LAg( P > 0. 05). The ODn value of the reagent in the condition of 37℃ and 4℃ did not change significantly,and the evaluation result of the international standard plate was consistent with the expected value. Conclusion When the LAg-avidity EIA method is used for HIV detection,the detection rate and error rate are basically similar to BED,but it is less affected by DC4+T cells,and has good stability and accuracy;therefore,it is more appropriate to be applied in clinical tests.