Performance evaluation of the new Access HIV Ag/Ab combo assay on the DxI 9000 Access Immunoassay Analyzer

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-07-07 DOI:10.1016/j.jcv.2024.105712

V. Lemée , S. Gréaume , J. Gautier , S.A. Dzamitika , C. Coignard , S.A. Jortani , B. Grillet , M. Badawi , J-C. Plantier

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引用次数: 0

Abstract

Fourth-generation HIV immunoassays have been developed to reduce the window period of detection during seroconversion period, allowing for the detection of early and established infections. The aim of this work was to evaluate a newly developed assay, Access HIV Ag/Ab combo on the novel high throughput DxI 9000 Access Immunoassay Analyzer (Beckman Coulter, Inc.). The assay allows for simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and HIV-1/2 antibodies.

Assay performance was compared to two gold standard assays, the Abbott Architect HIV Ag/Ab Combo and Roche Elecsys HIV Duo, and assessed in a multicenter study, using a wide panel of samples (n > 9000, clinical samples and viral lysates) representative of genetic diversity for both antibodies and antigens, early phases of infection, negative, and cross-reacting samples.

The clinical sensitivity was 100 % for clinical samples as well as for viral lysates. Data on viral lysates and early detection on seroconversion panels showed a better result with the Access assay. Analytical sensitivity showed a limit of p24 detection determined around 0.2 IU/mL. The overall specificity was 99.91 %, and no interference was found using the potentially cross-reactive samples.

In conclusion, the Access HIV Ag/Ab combo assay demonstrated its ability for accurate diagnosis of chronic as well as primary HIV infections on the DxI 9000 Analyzer, despite the high level of genetic diversity of these viruses.

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在 DxI 9000 Access 免疫测定分析仪上对新型 Access HIV Ag/Ab 组合测定的性能评估

第四代 HIV 免疫测定法的开发缩短了血清转换期的检测窗口期，从而可以检测早期和已确定的感染。这项工作的目的是在新型高通量 DxI 9000 Access 免疫分析仪（贝克曼库尔特公司）上对新开发的检测方法 Access HIV Ag/Ab 组合进行评估。该测定可同时定性检测和区分 HIV-1 p24 抗原和 HIV-1/2 抗体。测定性能与雅培 Architect HIV Ag/Ab Combo 和罗氏 Elecsys HIV Duo 这两种黄金标准测定法进行了比较，并在一项多中心研究中进行了评估，使用的样本范围很广（9000 个，临床样本和病毒裂解物），代表了抗体和抗原、感染早期、阴性和交叉反应样本的遗传多样性。病毒裂解物和血清转换面板的早期检测数据显示，Access 检测法的结果更好。分析灵敏度显示，p24 的检测限约为 0.2 IU/mL。总之，Access HIV Ag/Ab 组合检测法证明了它在 DxI 9000 分析仪上准确诊断慢性和原发性 HIV 感染的能力，尽管这些病毒的遗传多样性很高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)