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Clinical testing for COVID-19.
J Allergy Clin Immunol. 2020 Jul; 146(1):23-34.JA

Abstract

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.

Authors+Show Affiliations

Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.Division of Pharmacy, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: amal.assaad@cchmc.org.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

32445839

Citation

Ward, Stephanie, et al. "Clinical Testing for COVID-19." The Journal of Allergy and Clinical Immunology, vol. 146, no. 1, 2020, pp. 23-34.
Ward S, Lindsley A, Courter J, et al. Clinical testing for COVID-19. J Allergy Clin Immunol. 2020;146(1):23-34.
Ward, S., Lindsley, A., Courter, J., & Assa'ad, A. (2020). Clinical testing for COVID-19. The Journal of Allergy and Clinical Immunology, 146(1), 23-34. https://doi.org/10.1016/j.jaci.2020.05.012
Ward S, et al. Clinical Testing for COVID-19. J Allergy Clin Immunol. 2020;146(1):23-34. PubMed PMID: 32445839.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical testing for COVID-19. AU - Ward,Stephanie, AU - Lindsley,Andrew, AU - Courter,Josh, AU - Assa'ad,Amal, Y1 - 2020/05/20/ PY - 2020/04/11/received PY - 2020/05/13/revised PY - 2020/05/14/accepted PY - 2020/5/24/pubmed PY - 2020/7/17/medline PY - 2020/5/24/entrez KW - COVID-19 KW - Centers for Disease Control and Prevention KW - E protein KW - Food and Drug Administration KW - M protein KW - N protein KW - RT-PCR KW - S protein KW - SARS-CoV-2 KW - World Health Organization KW - coronavirus KW - guidance KW - nucleic acid test KW - point-of-care KW - prioritization KW - serologic test KW - test KW - viral genes SP - 23 EP - 34 JF - The Journal of allergy and clinical immunology JO - J Allergy Clin Immunol VL - 146 IS - 1 N2 - 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. SN - 1097-6825 UR - https://www.unboundmedicine.com/medline/citation/32445839/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0091-6749(20)30729-6 DB - PRIME DP - Unbound Medicine ER -