SARS-CoV-2 and Variant Diagnostic Testing Approaches in the United States.
SARS-CoV-2 and Variant Diagnostic Testing Approaches in the United States.
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DOI：
10.3390/v13122492
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发表时间：
2021-12-13
期刊：
影响因子：
--
通讯作者：
Andrews DM
中科院分区：
文献类型：
--
作者：
Thomas E;Delabat S;Carattini YL;Andrews DM
综述目的鉴于检测和诊断SARS-CoV-2及其相关变体（包括Omicron（B.1.1.529））感染的诊断方法的快速发展，有许多可用于诊断感染的选择。多个成熟的诊断公司现在提供测试平台，而最初，测试是使用标准实验室试剂进行简单的基于PCR的测试。其他检测平台仍在开发中，包括检测特定变异的平台，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，测试供应链得到了改善，越来越多的知名公司正在提供材料来支持这些测试工作。在美国，对快速测定开发和随后通过获得紧急使用授权（EUA）的批准的需要已经取代了FDA规定的传统的艰难的诊断测试批准工作流程。通过这些努力，美国能够继续显著提高其应对这一大流行病的检测能力;然而，由于所使用的检测的性能特征的多样性和新发现的病毒变体，挑战仍然存在。总结这篇综述概述了目前的诊断检测领域，以及与SARS-CoV-2病毒学、变异和抗体反应相关的信息，这些信息可用于诊断美国的感染。
Purpose of Review Given the rapid development of diagnostic approaches to test for and diagnose infection with SARS-CoV-2 and its associated variants including Omicron (B.1.1.529), many options are available to diagnose 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. Recent Findings Additional testing platforms continue to be developed, including those to detect specific variants, but challenges with testing, including obtaining testing reagents and other related supplies, are frequently encountered. With time, the testing supply chain has improved, and more established companies are providing materials to support these testing efforts. In the United States (U.S.), the need for rapid assay development and subsequent approval through the attainment of emergency use authorization (EUA) has superseded the traditional arduous diagnostic testing approval workflow mandated by the FDA. Through these efforts, the U.S. has been able to continue to significantly increase its testing capabilities to address this pandemic; however, challenges still remain due to the diversity of the performance characteristics of tests being utilized and newly discovered viral variants. Summary This review provides an overview of the current diagnostic testing landscape, with pertinent information related to SARS-CoV-2 virology, variants and antibody responses that are available to diagnose infection in the U.S.
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影响因子：
4.2
作者：
Hueston, Linda;Kok, Jen;O'Sullivan, Matthew V. N.
通讯作者：
O'Sullivan, Matthew V. N.
影响因子：
11.8
作者：
Hanson, Kimberly E.;Caliendo, Angela M.;Mustafa, Reem A.
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Mustafa, Reem A.
DOI：
10.15585/mmwr.mm6939a3
发表时间：
2020-10-02
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
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通讯作者：
CDC COVID-19 State, Tribal, Local, and Territorial Response Team
DOI：
10.1093/infdis/jiy098
发表时间：
2018-05-05
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
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通讯作者：
Cotten M
影响因子：
8.1
作者：
Gao H;Yao H;Yang S;Li L
通讯作者：
Li L