Diagnostic Testing for SARS-CoV-2 Infection.
Diagnostic Testing for SARS-CoV-2 Infection.
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DOI：
10.1007/s11901-021-00567-9
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Andrews DM
中科院分区：
文献类型：
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作者：
Thomas E;Delabat S;Andrews DM
鉴于检测和诊断SARS-CoV-2感染的诊断方法的迅速发展，有许多可用于评估感染的选择。多家已建立的诊断公司现在提供检测平台，而最初的检测是使用标准实验室试剂进行基于聚合酶链反应的简单检测。继续开发更多的检测平台，但经常遇到检测方面的挑战，包括获得检测试剂和其他相关用品。随着时间的推移，测试供应链将得到改善，更多的公司将提供材料来支持这些测试工作。在美国，通过获得紧急使用授权（EUA）对快速检测开发和随后批准的需求已经取代了FDA规定的传统的艰巨的诊断测试批准工作流程。预计美国将能够继续大幅提高其检测能力，以应对这一流行病；然而，由于所使用的测试的性能特征的多样性，挑战仍然存在。本文综述了当前诊断检测的概况，以及与SARS-CoV-2病毒学和抗体反应相关的相关信息，这些信息可用于诊断感染。
Given the rapid development of diagnostic approaches to test for and diagnose infection with SARS-CoV-2, many options are available to assess infection. Multiple established diagnostic companies are now providing testing platforms whereas initially, testing was being performed with simple PCR-based tests using standard laboratory reagents. Additional testing platforms continue to be developed but challenges with testing, including obtaining testing reagents and other related supplies, are frequently encountered. With time, the testing supply chain will improve and more companies will be providing materials to support these testing efforts. In the USA, the need for rapid assay development and subsequent approval through attainment of emergency use authorization (EUA) has superseded the traditional arduous diagnostic testing approval workflow mandated by the FDA. It is anticipated that the USA will be able to continue to significantly increase its testing capabilities to address this pandemic; however, challenges remain due to the diversity of the performance characteristics of tests being utilized. This review provides an overview of the current diagnostic testing landscape, with pertinent information related to SARS-CoV-2 virology and antibody responses, that is available to diagnose infection.