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用于 SARS-CoV-2 适应性免疫反应的快速抗体诊断。

Rapid antibody diagnostics for SARS-CoV-2 adaptive immune response.

机构信息

Department of Chemistry, College of Science, University of Hafr Al Batin, PO Box 1803, Hafr Al Batin, 39524, Saudi Arabia.

Department of Biosciences, College of Science, University of Hafr Al Batin, PO Box 1803, Hafr Al Batin, 39524, Saudi Arabia.

出版信息

Anal Methods. 2021 Sep 23;13(36):4019-4037. doi: 10.1039/d1ay00888a.

Abstract

The emergence of a pandemic scale respiratory illness (COVID-19: coronavirus disease 2019) and the lack of the world's readiness to prevent its spread resulted in an unprecedented rise of biomedical diagnostic industries, as they took lead to provide efficient diagnostic solutions for COVID-19. However, these circumstances also led to numerous emergency use authorizations without appropriate evaluation that compromised standards, which could result in a larger than usual number of false-positive or false-negative results, leading to unwanted ambiguity in already confusing realities of the pandemic-hit closures of the world economy. This review is aimed at comparing the claimed or reported clinical sensitivity and clinical specificity of commercially available rapid antibody diagnostics with independently evaluated clinical performance results of the tests. Thereby, we not only present the types of modern antibody diagnostics and their working principles but summarize their experimental evaluations and observed clinical efficiencies to highlight the research, development, and commercialization issues with future challenges. Still, it must be emphasized that the serological or antibody tests do not serve the purpose of early diagnosis but are more suitable for epidemiology and screening populaces with an active immune response, recognizing convalescent plasma donors, and determining vaccine efficacy.

摘要

一种大流行规模的呼吸道疾病(COVID-19:2019 年冠状病毒病)的出现,以及世界缺乏预防其传播的准备,导致生物医学诊断行业空前崛起,因为它们率先为 COVID-19 提供有效的诊断解决方案。然而,这些情况也导致了许多未经适当评估的紧急使用授权,这些授权降低了标准,可能导致比平时更多的假阳性或假阴性结果,从而在已经令人困惑的大流行经济关闭现实中造成不必要的模糊性。本综述旨在比较市售快速抗体诊断试剂声称或报告的临床灵敏度和临床特异性与独立评估的测试临床性能结果。因此,我们不仅介绍了现代抗体诊断的类型及其工作原理,还总结了它们的实验评估和观察到的临床效率,以突出研究、开发和商业化面临的未来挑战问题。不过,仍必须强调的是,血清学或抗体检测不适用于早期诊断,而更适合用于具有主动免疫反应的流行病学和人群筛查,以识别恢复期血浆供体,并确定疫苗效力。

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