Spicuzza Lucia, Campagna Davide, Di Maria Chiara, Sciacca Enrico, Mancuso Salvatore, Vancheri Carlo, Sambataro Gianluca
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
AIMS Microbiol. 2023 Apr 13;9(2):375-401. doi: 10.3934/microbiol.2023020. eCollection 2023.
Over the last three years, after the outbreak of the COVID-19 pandemic, an unprecedented number of novel diagnostic tests have been developed. Assays to evaluate the immune response to SARS-CoV-2 have been widely considered as part of the control strategy. The lateral flow immunoassay (LFIA), to detect both IgM and IgG against SARS-CoV-2, has been widely studied as a point-of-care (POC) test. Compared to laboratory tests, LFIAs are faster, cheaper and user-friendly, thus available also in areas with low economic resources. Soon after the onset of the pandemic, numerous kits for rapid antibody detection were put on the market with an emergency use authorization. However, since then, scientists have tried to better define the accuracy of these tests and their usefulness in different contexts. In fact, while during the first phase of the pandemic LFIAs for antibody detection were auxiliary to molecular tests for the diagnosis of COVID-19, successively these tests became a tool of seroprevalence surveillance to address infection control policies. When in 2021 a massive vaccination campaign was implemented worldwide, the interest in LFIA reemerged due to the need to establish the extent and the longevity of immunization in the vaccinated population and to establish priorities to guide health policies in low-income countries with limited access to vaccines. Here, we summarize the accuracy, the advantages and limits of LFIAs as POC tests for antibody detection, highlighting the efforts that have been made to improve this technology over the last few years.
在过去三年新冠疫情爆发后,大量新型诊断测试被开发出来。评估针对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)免疫反应的检测方法被广泛视为防控策略的一部分。用于检测针对SARS-CoV-2的IgM和IgG的侧向流动免疫分析(LFIA)作为一种即时检测(POC)方法受到了广泛研究。与实验室检测相比,LFIA速度更快、成本更低且用户友好,因此在经济资源匮乏地区也可使用。疫情爆发后不久,众多用于快速抗体检测的试剂盒凭借紧急使用授权进入市场。然而,从那时起,科学家们一直试图更好地界定这些检测的准确性及其在不同情况下的实用性。事实上,在疫情的第一阶段,用于抗体检测的LFIA是诊断新冠病毒的分子检测的辅助手段,随后这些检测成为了血清流行率监测的工具,以指导感染控制政策。2021年全球开展大规模疫苗接种运动时,由于需要确定接种人群的免疫程度和持续时间,并在疫苗获取有限的低收入国家确定指导卫生政策的优先事项,对LFIA的兴趣再度兴起。在此,我们总结了LFIA作为抗体检测即时检测方法的准确性、优点和局限性,突出了过去几年为改进这项技术所做的努力。
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