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针对新型大流行的生物技术准备:即时诊断系统对严重急性呼吸综合征冠状病毒2的诊断性能

Biotechnological Preparedness for Novel Pandemics: Diagnostic Performance of IVDS Against SARS-CoV-2.

作者信息

Kavruk Murat, Ercan Meltem, Borsa Barış Ata, Özalp Veli Cengiz, Hernandez Frank J

机构信息

Department of Medical Biology and Genetics, Faculty of Medicine, Department of Molecular Biology and Genetics, Faculty of Arts & Sciences, İstanbul Aydın University, İstanbul, Türkiye.

Department of Physics, Chemistry and Biology (IFM), Linköping University, Linköping, Sweden.

出版信息

Microbiologyopen. 2025 Aug;14(4):e70042. doi: 10.1002/mbo3.70042.

Abstract

Although the COVID-19 pandemic has created many challenges and negative impacts around the world, some of which will persist into the future, its technological challenge has created a unique opportunity in a globalized world. It is a rare event that almost all of humanity to be directed towards a single goal and to try to produce solutions, but the necessity of a similar global action in the future has begun to enter the agenda again. The predictions made on the basis of countries and institutions against the possibility of a pandemic, which is defined as Disease X, are shaped by the experience of the COVID-19 pandemic. Technologically, one of the know-how we have gained in this pandemic is the performance of IVD and test systems in terms of quality and quantity. A comprehensive analysis of the products produced by combining biotechnology with different strategies has not been conducted. In this context, we have analyzed the technical preferences, limitations, and other performance parameters of IVDs and test kits that could be developed against a future Disease X. The performance parameters of 2,882 biotechnological products listed for use in the European Union have been analyzed, and areas that could be targeted for increased effectiveness have been identified. Our study is the first of its kind in this field and can serve as a guide for those who want to work on detection methods, diagnostics, and novel technologies for deployment in future pandemics.

摘要

尽管新冠疫情在全球造成了诸多挑战和负面影响,其中一些影响还将持续至未来,但它带来的技术挑战在全球化的世界中创造了一个独特机遇。几乎全人类都朝着一个单一目标努力并尝试提出解决方案,这是极为罕见的情况,不过未来类似全球行动的必要性已再次提上议程。基于各国和各机构针对一种被定义为“X疾病”的大流行可能性所做的预测,是由新冠疫情的经验塑造而成的。从技术层面来看,我们在此次疫情中获得的一项专业知识就是体外诊断(IVD)和检测系统在质量和数量方面的表现。目前尚未对将生物技术与不同策略相结合所生产的产品进行全面分析。在此背景下,我们分析了针对未来“X疾病”可能开发的体外诊断产品和检测试剂盒的技术偏好、局限性及其他性能参数。我们对欧盟列出的2882种用于生物技术产品的性能参数进行了分析,并确定了可针对提高有效性的目标领域。我们的研究在该领域尚属首次,可为那些希望致力于未来大流行中检测方法、诊断技术及新技术研发的人士提供指导。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0aba/12319721/229c6773359d/MBO3-14-e70042-g005.jpg

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