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目的比较限制性抗原亲和力酶免法(简称LAg)与BED捕获酶免法(简称BED)用于人类免疫缺陷病毒1型(HIV-1)新发感染检测的结果,评价2种方法的适用性。方法应用LAg和BED 2种方法同时检测HIV抗体阳性急性感染期、发病期、常规报告病例样品,用Mc Nermar检验2种方法新发感染检出率和一致性。结果 24份HIV抗体阳性急性感染期病例样品,LAg判定新发感染23份(95.83%),BED判定新发感染24份(100.00%)。328份常规报告病例样品,LAg判定长期感染237份(72.26%),BED判定长期感染224份(68.30%)。71份发病期病例样品,LAg判定长期感染49份(69.01%),BED判定长期感染46份(64.79%)。Mc Nermar检验2种方法对常规报告病例、发病期病例样品及不同的CD4+T细胞计数判定新发感染结果一致性差异均有统计学意义(P<0.01)。结论 LAg新发感染检出率及错判率低于BED,受CD4+T细胞计数影响较BED小,更加真实地反映新发感染情况。
OBJECTIVE: To compare the applicability of the two methods for the detection of new HIV-1 infection by restrictive antigen affinity enzyme immunoassay (LAg) and BED-capture enzyme immunoassay (BED) for human immunodeficiency virus type 1 (HIV-1) . Methods Two kinds of methods, LAg and BED, were used to simultaneously detect HIV-positive acute infection phase, onset phase and routine reported cases. The detection rate and consistency of two new infections by McNermar were tested. Results Twenty-four cases of HIV-positive acute infection were detected by LAg, 23 (95.83%) were newly diagnosed by LAg and 24 (100.00%) were newly diagnosed by BED. Of the 328 routinely reported cases, 237 (72.26%) were identified by LAg as long-term and 224 (68.30%) as long-term infections by BED. In the 71 cases of onset, 49 cases (69.01%) were confirmed as long-term infection by LAg, and 46 cases (64.79%) by long-term infection by BED. McNermar test two methods for routine reporting cases, the onset of cases and different CD4 + T cell counts to determine the consistency of the new infection results were statistically significant (P <0.01). Conclusions The detection rate of newly diagnosed LAg and the rate of misdiagnosis are lower than those of BED, and are less affected by the count of CD4 + T cells than BED, which reflects the new infection more realistically.