Thomas Emmanuel, Delabat Stephanie, Andrews David M
Department of Microbiology & Immunology, University of Miami Miller School of Medicine, Miami, FL USA.
Schiff Center for Liver Disease, University of Miami Miller School of Medicine, 1550 NW 10th Ave., Papanicolaou Bldg., RM PAP 514, Miami, FL 33136 USA.
Curr Hepatol Rep. 2021;20(4):166-174. doi: 10.1007/s11901-021-00567-9. Epub 2021 Oct 28.
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need for rapid assay development and subsequent approval through attainment of emergency use authorization (EUA) has superseded the traditional arduous diagnostic testing approval workflow mandated by the FDA.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.
鉴于检测和诊断新型冠状病毒2（SARS-CoV-2）感染的诊断方法迅速发展，有多种方法可用于评估感染情况。许多成熟的诊断公司现在都在提供检测平台，而最初，检测是使用标准实验室试剂通过简单的基于聚合酶链反应（PCR）的检测来进行的。
更多的检测平台仍在不断开发，但检测过程中经常会遇到挑战，包括获取检测试剂和其他相关耗材。随着时间的推移，检测供应链将会改善，会有更多公司提供物资以支持这些检测工作。在美国，快速检测方法的开发以及随后通过获得紧急使用授权（EUA）获得批准的需求，已经取代了美国食品药品监督管理局（FDA）规定的传统的繁琐诊断检测批准流程。预计美国将能够继续大幅提高其检测能力以应对这一疫情；然而，由于所使用检测方法的性能特征存在差异，挑战依然存在。
本综述概述了当前的诊断检测情况，以及可用于诊断感染的与SARS-CoV-2病毒学和抗体反应相关的重要信息。
