Weber B, Mühlbacher A, Michl U, Paggi G, Bossi V, Sargento C, Camacho R, Fall E H, Berger A, Schmitt U, Melchior W
Laboratoires Réunis Kutter-Lieners-Hastert, Centre Langwies, Junglinster, Luxembourg.
J Virol Methods. 1999 Mar;78(1-2):61-70. doi: 10.1016/s0166-0934(98)00162-1.
Although human immunodeficiency virus (HIV) antigen assays are of limited value for monitoring antiretroviral therapy, they play an important role for confirmatory testing of fourth generation HIV screening enzyme immunoassay (EIA) reactive samples. In a multicenter study, a new automated rapid p24 antigen assay, Elecsys HIV Ag (Roche Diagnostics Boehringer Mannheim GmbH, Penzberg, Germany), was compared to FDA licensed tests (Abbott HIV-1 Ag monoclonal and Coulter HIV-1 p24 antigen assay). In the evaluation 27 seroconversion panels were included, sera from the acute phase of infection, single and follow-up samples from HIV antibody positive patients, dilution series of HIV antigen positive standards, sera and cell culture supernatants infected with different HIV-1 subtypes (A-H, and O) HIV-2 and recombinant HIV-1 (gag/env) isolates. To challenge the specificity of the new assay, 2565 unselected blood donors, sera from pregnant women, dialysis and hospitalized patients and 407 potentially cross-reactive samples were investigated. Acute HIV infection was detected in three to eight seroconversion panels earlier with Elecsys HIV Ag than with the alternative assays. Higher numbers of serum samples from HIV infected patients tested positive by Elecsys HIV Ag than with the comparative assays. All HIV-1 subtypes and HIV-2 isolates were recognized with Elecsys HIV Ag. Abbott HIV-1 Ag monoclonal and Coulter HIV-1 p24 antigen assay showed a variable sensitivity for the different HIV-1 subtypes. The specificity of Elecsys HIV Ag and Coulter HIV-1 p24 antigen assay were 99.8 and 99.93%, respectively. All the eight sera that were false reactive by Elecsys HIV Ag were tested negative with the Elecsys HIV Ag Neutralization Test. In conclusion, Elecsys HIV Ag was more sensitive than the alternative assays and showed a high specificity in combination with the neutralization assay. The very short incubation time of 18 min and the fully automated procedure of Elecsys HIV Ag which permits direct testing from the primary patient blood collection tube, represent a major improvement for routine laboratory diagnosis in comparison to the alternative assays.
虽然人类免疫缺陷病毒（HIV）抗原检测在监测抗逆转录病毒治疗方面价值有限，但它们在第四代HIV筛查酶免疫测定（EIA）反应性样本的确认检测中发挥着重要作用。在一项多中心研究中，将一种新的自动化快速p24抗原检测方法Elecsys HIV Ag（德国彭茨贝格的罗氏诊断宝灵曼有限公司）与美国食品药品监督管理局（FDA）许可的检测方法（雅培HIV-1 Ag单克隆检测和库尔特HIV-1 p24抗原检测）进行了比较。在评估中，纳入了27个血清转化样本组、感染急性期的血清、HIV抗体阳性患者的单次和随访样本、HIV抗原阳性标准品的稀释系列、感染不同HIV-1亚型（A - H和O）、HIV-2以及重组HIV-1（gag/env）分离株的血清和细胞培养上清液。为了检验新检测方法的特异性，对2565名未经筛选的献血者、孕妇、透析患者和住院患者的血清以及407份可能存在交叉反应的样本进行了研究。与其他检测方法相比，Elecsys HIV Ag能在三到八个血清转化样本组中更早地检测到急性HIV感染。Elecsys HIV Ag检测出的HIV感染患者血清样本阳性数量多于比较检测方法。Elecsys HIV Ag能够识别所有HIV-1亚型和HIV-2分离株。雅培HIV-1 Ag单克隆检测和库尔特HIV-1 p24抗原检测对不同HIV-1亚型的敏感性各不相同。Elecsys HIV Ag和库尔特HIV-1 p24抗原检测的特异性分别为99.8%和99.93%。所有Elecsys HIV Ag检测呈假阳性的八份血清在Elecsys HIV Ag中和试验中检测为阴性。总之，Elecsys HIV Ag比其他检测方法更敏感，并且与中和试验结合显示出高特异性。与其他检测方法相比，Elecsys HIV Ag的孵育时间仅为18分钟，且完全自动化，允许直接从患者原始采血管进行检测，这代表了常规实验室诊断的一项重大改进。
