Clinical testing for COVID-19

• Published in: Journal of allergy and clinical immunology Vol. 146; no. 1; pp. 23 - 34
• Main Authors: Ward, Stephanie, Lindsley, Andrew, Courter, Josh, Assa’ad, Amal
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2020; Mosby
• Subjects: Betacoronavirus; Centers for Disease Control and Prevention; Clinical Laboratory Techniques - methods; coronavirus; Coronavirus Infections - diagnosis; COVID-19; COVID-19 Testing; E protein; Food and Drug Administration; guidance; Humans; M protein; N protein; nucleic acid test; Pandemics; Pneumonia, Viral - diagnosis; point-of-care; Point-of-Care Testing; prioritization; Real-Time Polymerase Chain Reaction - methods; RT-PCR; S protein; SARS-CoV-2; serologic test; Serologic Tests - methods; test; viral genes; Viral Proteins - analysis; World Health Organization; NAT; FDA; CDC; viral genes; E protein; nucleic acid test; N; COVID-19; EUA; SARS-CoV-2; serologic test; S; Centers for Disease Control and Prevention; RT-PCR; IFU; S protein; point-of-care; Food and Drug Administration; WHO; LOD; World Health Organization; test; N protein; POC; coronavirus; prioritization; CCHMC; guidance; M protein
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2020.05.012

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.