COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19.
COVID-19 Special Column: Principles Behind the Technology for Detecting SARS-CoV-2, the Cause of COVID-19.
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发表时间：
2020-05
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通讯作者：
Lauren L. Ching;Sandra P Chang;V. Nerurkar
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作者：
Lauren L. Ching;Sandra P Chang;V. Nerurkar
美国食品和药物管理局（FDA）在全国范围内缺乏检测严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）和诊断冠状病毒病2019 （COVID-19）的检测工具，这导致美国食品和药物管理局（FDA）大幅放宽了对COVID-19诊断检测的规定。迄今为止，FDA已向48种COVID-19体外诊断测试和21种高复杂性基于分子的实验室开发测试提供了紧急使用授权（EUA），并实施了政策，赋予临床实验室和商业制造商在开发、分销和使用COVID-19诊断测试方面的广泛权力。目前，可用于检测SARS-CoV-2的诊断检测有两种类型：(1)分子检测和(2)血清学检测。与疑似病原体相关的核酸（RNA或DNA）序列的分子检测表明疑似病原体存在活动性感染。血清学测试检测抗体对抗疑似病原体，这是由个人的免疫系统产生的。血清学试验阳性结果表明最近接触过疑似病原体，但不能用于确定个体是否积极感染病原体或对再感染免疫。本文回顾了目前FDA根据EUA批准的SARS-CoV-2诊断测试，并讨论了研究人员正在开发的用于检测SARS-CoV-2感染的其他诊断测试。
Nationwide shortages of tests that detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and diagnose coronavirus disease 2019 (COVID-19) have led the US Food and Drug Administration (FDA) to significantly relax regulations regarding COVID-19 diagnostic testing. To date the FDA has given emergency use authorization (EUA) to 48 COVID-19 in vitro diagnostic tests and 21 high complexity molecular-based laboratory developed tests, as well as implemented policies that give broad authority to clinical laboratories and commercial manufacturers in the development, distribution, and use of COVID-19 diagnostic tests. Currently, there are 2 types of diagnostic tests available for the detection of SARS-CoV-2: (1) molecular and (2) serological tests. Molecular detection of nucleic acid (RNA or DNA) sequences relating to the suspected pathogen is indicative of an active infection with the suspected pathogen. Serological tests detect antibodies against the suspected pathogen, which are produced by an individual's immune system. A positive serological test result indicates recent exposure to the suspected pathogen but cannot be used to determine if the individual is actively infected with the pathogen or immune to reinfection. In this article, the SARS-CoV-2 diagnostic tests currently approved by the FDA under EUA are reviewed, and other diagnostic tests that researchers are developing to detect SARS-CoV-2 infection are discussed.