Translational Biomarkers, Merck & Co., Inc., Kenilworth, New Jersey, USA.
Oncology Early Development, Merck & Co., Inc., Rahway, New Jersey, USA.
Clin Transl Sci. 2020 Sep;13(5):871-876. doi: 10.1111/cts.12828. Epub 2020 Jun 29.
In the last few months, an unprecedented number of laboratory tests for coronavirus disease 2019 (COVID-19) have been developed at a remarkable speed. With the rapid adoption of these tests into clinical practice, combined with the widespread publicity they received, questions arose related to the different types of tests, their utility, performance, and regulatory approval status. The aim of this publication is to provide a general landscape of laboratory testing for COVID-19 and offer a historical and regulatory perspective associated with them. Specifically, we aim to elaborate on the regulatory complexities of diagnostic testing in the United States and its implications to the present outbreak, as well as provide a synopsis of laboratory tests that have been developed for COVID-19. We will first address the detection of severe acute respiratory syndrome-coronavirus 2 directly by either nucleic acid amplification tests or by the detection of the viral protein for active infections. Subsequently, we will provide an overview of serological tests that can aid not only in diagnosis but additionally help to identify prior infections and potential immunity.
在过去的几个月里，以惊人的速度开发了大量用于检测 2019 年冠状病毒病（COVID-19）的实验室检测方法。随着这些检测方法在临床实践中的迅速采用，再加上它们广泛的宣传，人们开始关注不同类型的检测方法、它们的实用性、性能以及监管批准状况。本出版物旨在提供 COVID-19 实验室检测的总体情况，并提供与之相关的历史和监管视角。具体而言，我们旨在详细阐述美国诊断检测的监管复杂性及其对当前疫情的影响，并概述为 COVID-19 开发的实验室检测方法。我们将首先讨论直接通过核酸扩增检测或病毒蛋白检测来检测严重急性呼吸综合征冠状病毒 2 的方法，用于检测活跃感染。随后，我们将概述有助于诊断的血清学检测方法，这些检测方法还可以帮助识别既往感染和潜在的免疫情况。
