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首页> 外文期刊>AIDS Research and Human Retroviruses >Development and Evaluation of a Modified Fourth-Generation Human Immunodeficiency Virus Enzyme Immunoassay for Cross-Sectional Incidence Estimation in Clade B Populations
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Development and Evaluation of a Modified Fourth-Generation Human Immunodeficiency Virus Enzyme Immunoassay for Cross-Sectional Incidence Estimation in Clade B Populations

机译：改良的第四代人类免疫缺陷病毒酶免疫测定法在进化枝B种群中的横断面估计的开发和评估。

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Background: Accurate methods for cross-sectional incidence estimation are needed for HIV surveillance and prevention research. We developed an avidity assay based on the fourth-generation Genetic Systems HIV Combo Ag/Ab EIA (Bio-Rad Combo assay) and evaluated its performance. Materials and Methods: The Bio-Rad Combo assay was modified incubating samples with and without 0.025M diethylamine (DEA). The avidity index (AI) was calculated as the ratio of the DEA-treated to untreated result for a specific sample. We analyzed 2,140 samples from 808 individuals from the United States with known duration of HIV infection. The mean duration of recent infection (MDRI) and the false-recent rate (FRR, fraction of samples from individuals known to be infected >2 years misclassified as recent) were calculated for AI cutoffs of 20%-90% for the avidity assay alone and in combination with a viral load assay (VL, limit of detection 400 copies/ml). Factors associated with misclassification of samples collected >= 2 years after infections were also evaluated. Results: The MDRI for the Bio-Rad Combo Avidity assay ranged from 50 days using an AI cutoff of 20% to 276 days using an AI cutoff of 90%; the FRR ranged from 0% to 9%. When samples with a VL <400 copies/ml were classified as nonrecent, the FRRs were reduced approximately twofold and the MDRI estimates were reduced by similar to 20%. An AI cutoff of 50% provided an MDRI of 135 days with an FRR of 2.1%. All samples from elite suppressors had an AI >80%. In adjusted analysis, viral suppression and low CD4 cell count were significantly associated with misclassification among individuals infected >2 years. Conclusions: This modified Bio-Rad Combo Avidity assay may be a useful tool for cross-sectional HIV incidence estimation. Further research is needed to evaluate use of this assay in combination with other assays to accurately estimate population-level HIV incidence.
机译：背景：HIV监测和预防研究需要准确的横断面发病率估算方法。我们基于第四代遗传系统HIV Combo Ag / Ab EIA（Bio-Rad Combo试验）开发了一种亲和力试验，并评估了其性能。材料和方法：改进了Bio-Rad Combo分析方法，可在有和没有0.025M二乙胺（DEA）的情况下孵育样品。亲和力指数（AI）计算为特定样品经DEA处理与未处理结果之比。我们分析了来自美国808个人的2140个样本，这些样本具有已知的HIV感染时间。仅针对亲和力测定，AI截止值的计算得出了最近感染的平均持续时间（MDRI）和假近期发生率（FRR，已知感染个体> 2年的样本比例被误分类为最近）并与病毒载量测定法（VL，检出限400拷贝/ ml）结合使用。还评估了与感染后≥2年收集的样本分类错误相关的因素。结果：用于Bio-Rad Combo Avidity分析的MDRI范围从50％（使用20％的AI截止）到276天（使用90％的AI截止）; FRR范围从0％到9％。当VL <400拷贝/ ml的样品分类为不最新时，FRR降低约两倍，而MDRI估计值降低约20％。 50％的AI截止值提供了135天的MDRI，FRR为2.1％。来自精英抑制器的所有样品的AI均> 80％。在调整后的分析中，感染> 2年的个体中病毒抑制和低CD4细胞计数与错误分类显着相关。结论：这种改良的Bio-Rad Combo亲和力测定法可能是横截面HIV发生率估算的有用工具。需要进行进一步的研究以评估该分析方法与其他分析方法的结合使用，以准确估计人群水平的HIV发生率。

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