Analytical sensitivity of four HIV combined antigen/antibody assays using the p24 WHO standard
Analytical sensitivity of four HIV combined antigen/antibody assays using the p24 WHO standard
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DOI：
10.1016/j.jcv.2010.09.003
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发表时间：
2011-01-01
影响因子：
8.8
通讯作者：
Izopet, Jacques
中科院分区：
文献类型：
--
作者：
Miedouge, Marcel;Greze, Monique;Izopet, Jacques
背景：2009年发布的《HIV-1 p24测定法通用技术规范》将获得C. E.批准的检测下限固定为2 IU/ml（第一个国际参考标准，代码NIBSC 90/636）；之前是50pg /ml。近年来，一些同时检测抗原和抗体的第四代HIV检测方法与p24检测方法相当，但它们主要以pg/ml为p24抗原标准进行评估，而以IU/ml为标准进行评估的效果尚不清楚。目的：根据世界卫生组织的IU/ml标准，评估法国最常用的四种联合血清学检测方法。研究设计：采用WHO标准的稀度，测定4种p24抗原和抗体联合检测（ARCHITECT HIV Ag/Ab Combo、AxSYM HIV Ag/Ab Combo、VIDAS HIV DUO Quick和VIDAS HIV DUO Ultra）和1种p24检测（VIDAS HIV p24 II）的分析灵敏度。结果：5种检测方法中有4种检测下限低于2 IU/ml: ARCHITECT Combo为1.24，VIDAS DUO Ultra为0.66，VIDAS DUO Quick为0.43，VIDAS p24为0.73 ~ 1.15，AxSYM接近2（1.94 ~ 2.25）。结论：我们首次提供了使用IU/ml WHO标准的HIV联合检测下限的数据，并证明了需要一个单一的国际标准来比较检测。我们建议在医学实验室使用这种方法来现场验证他们的方法。(C) 2010 Elsevier B.V.版权所有
Background: The Common Technical Specifications for HIV-1 p24 assays published in 2009 fixed the lower limit of detection for obtaining C. E. approval at 2 IU/ml against the WHO standard (first international reference, code NIBSC 90/636); it was previously 50 pg/ml. Some recent fourth generation HIV assays that simultaneously detect antigen and antibody are equivalent to p24 assays, but they were mainly evaluated using p24 antigen standards in pg/ml and little is known of their performance with the IU/ml standard.Objectives: To evaluate four of the combined serological assays most commonly used for HIV diagnosis in France against the WHO standard in IU/ml.Study design: The analytical sensitivity of four combined p24 antigen and antibody assays (ARCHITECT HIV Ag/Ab Combo, AxSYM HIV Ag/Ab Combo, VIDAS HIV DUO Quick and VIDAS HIV DUO Ultra) and of one p24 assay (VIDAS HIV p24 II) were determined using dilutions of the WHO standard.Results: Four of the five assays had a lower limit of detection below 2 IU/ml: 1.24 for ARCHITECT Combo, 0.66 for VIDAS DUO Ultra, 0.43 for VIDAS DUO Quick and 0.73 to 1.15 for VIDAS p24, while that of AxSYM was close to 2 (1.94-2.25).Conclusions: We have provided the first data on the lower limit of detection of HIV combined assays using the IU/ml WHO standard and demonstrated the need for a single international standard for comparing assays. We recommend the use of this approach in medical laboratory to validate on site their methods. (C) 2010 Elsevier B.V. All rights reserved.