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Clinical testing for COVID-19.
Journal of Allergy and Clinical Immunology ( IF 11.4 ) Pub Date : 2020-05-20 , DOI: 10.1016/j.jaci.2020.05.012
Stephanie Ward 1 , Andrew Lindsley 1 , Josh Courter 2 , Amal Assa'ad 1
Affiliation  

As the novel coronavirus severe acute respiratory syndrome coronavirus 2 caused coronavirus disease 2019 cases in the United States, the initial test was developed and performed at the Centers for Disease Control and Prevention. As the number of cases increased, the demand for tests multiplied, leading the Centers for Disease Control and Prevention to use the Emergency Utilization Authorization to allow clinical and commercial laboratories to develop tests to detect the presence of the virus. Many nucleic acid tests based on RT-PCR were developed, each with different techniques, specifications, and turnaround time. As the illnesses turned into a pandemic, testing became more crucial. The test supply became inadequate to meet the need and so it had to be prioritized according to guidance. For surveillance, the need for serologic tests emerged. Here, we review the timeline of test development, the turnaround times, and the various approved tests, and compare them as regards the genes they detect. We concentrate on the point-of-care tests and discuss the basis for new serologic tests. We discuss the testing guidance for prioritization and their application in a hospital setting.



中文翻译:

COVID-19 的临床测试。

由于新型冠状病毒严重急性呼吸综合征冠状病毒2在美国引起了2019年冠状病毒病,因此最初的测试是在疾病控制和预防中心开发并进行的。随着病例数量的增加,对测试的需求成倍增加,导致疾病控制和预防中心使用紧急使用授权,允许临床和商业实验室开发测试来检测病毒的存在。人们开发了许多基于 RT-PCR 的核酸检测方法,每种方法都有不同的技术、规格和周转时间。随着疾病演变为大流行,检测变得更加重要。测试供应不足以满足需求,因此必须根据指导确定优先顺序。为了进行监测,需要进行血清学检测。在这里,我们回顾了测试开发的时间表、周转时间和各种已批准的测试,并对它们检测到的基因进行了比较。我们专注于即时检测并讨论新血清学检测的基础。我们讨论优先级测试指南及其在医院环境中的应用。

更新日期:2020-07-03
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