Rapid antibody diagnostics for SARS-CoV-2 adaptive immune response,Analytical Methods

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Rapid antibody diagnostics for SARS-CoV-2 adaptive immune response
Analytical Methods ( IF 2.7 ) Pub Date : 2021-08-16 , DOI: 10.1039/d1ay00888a
Adeel Afzal ₁ , Naseer Iqbal ₁ , Saima Feroz ₂ , Asghar Ali ₁ , Muhammad Ali Ehsan ₃ , Safyan Akram Khan ₃ , Abdul Rehman ₄

Affiliation

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.

中文翻译：

SARS-CoV-2 适应性免疫反应的快速抗体诊断

大流行规模的呼吸道疾病（COVID-19：2019 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兴起，因为它们率先为 COVID-19 提供了有效的诊断解决方案。 19. 然而，这些情况也导致许多紧急使用授权未经适当评估而损害标准，这可能导致假阳性或假阴性结果的数量比平常多，从而导致在已经令人困惑的大流行病现实中出现不必要的歧义世界经济关闭。本综述旨在将商业上可用的快速抗体诊断的声称或报告的临床敏感性和临床特异性与独立评估的测试临床性能结果进行比较。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，以突出未来挑战的研究、开发和商业化问题。尽管如此，必须强调的是，血清学或抗体测试不服务于早期诊断的目的，但更适用于流行病学和筛选具有活跃免疫反应的人群，识别恢复期的血浆供体，并确定疫苗效力。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，以突出未来挑战的研究、开发和商业化问题。尽管如此，必须强调的是，血清学或抗体测试不服务于早期诊断的目的，但更适用于流行病学和筛选具有活跃免疫反应的人群，识别恢复期的血浆供体，并确定疫苗效力。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，以突出未来挑战的研究、开发和商业化问题。尽管如此，必须强调的是，血清学或抗体检测不用于早期诊断，但更适用于流行病学和筛选具有活跃免疫反应的人群，识别恢复期的血浆供体和确定疫苗效力。

更新日期：2021-08-26

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