Clinical testing for COVID-19

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:146

Article

Ward, Stephanie¹  Lindsley, Andrew¹  Courter, Josh²  Assa'ad, Amal¹ 

[1] Cincinnati Childrens Hosp Med Ctr, Div Allergy & Immunol, 3333 Burnet Ave, Cincinnati, OH 45229 USA

[2] Cincinnati Childrens Hosp Med Ctr, Div Pharm, Cincinnati, OH 45229 USA

关键词: COVID-19;    coronavirus;    SARS-CoV-2;    viral genes;    S protein;    N protein;    E protein;    M protein;    RT-PCR;    test;    point-of-care;    prioritization;    guidance;    Centers for Disease Control and Prevention;    Food and Drug Administration;    World Health Organization;    nucleic acid test;    serologic test;   

DOI  :  10.1016/j.jaci.2020.05.012

来源: Elsevier

【 摘 要 】

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.

【 授权许可】

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