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Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays.
J Clin Virol. 2020 06; 127:104384.JC

Abstract

In December 2019, a novel coronavirus (SARS-CoV-2) was first isolated from Wuhan city, China and within three months, the global community was challenged with a devastating pandemic. The rapid spread of the virus challenged diagnostic laboratories to rapidly develop molecular diagnostic methods. As SARS CoV-2 assays became available for testing on existing molecular platforms, laboratories devoted unprecedented energy and resources into evaluating the analytical performance of the new tests and in some cases developed their own diagnostic assays under FDA-EUA guidance. This study compares the validation of three different molecular assays at the Johns Hopkins Molecular Virology laboratory: the RealStar® SARS-CoV-2 RT-PCR, ePlex® SARS-CoV-2, and the CDC COVID-19 RT-PCR tests. Overall, our studies indicate a comparable analytical performance of the three assays for the detection of SARS-CoV-2.

Authors+Show Affiliations

Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA. Electronic address: Kcarrol7@jhmi.edu.Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Meyer B-121F, 600 North Wolfe Street, Baltimore, MD 21287-7093, USA. Electronic address: Hmostaf2@jhmi.edu.

Pub Type(s)

Comparative Study
Journal Article
Validation Study

Language

eng

PubMed ID

32361285

Citation

Uhteg, Katharine, et al. "Comparing the Analytical Performance of Three SARS-CoV-2 Molecular Diagnostic Assays." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 127, 2020, p. 104384.
Uhteg K, Jarrett J, Richards M, et al. Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays. J Clin Virol. 2020;127:104384.
Uhteg, K., Jarrett, J., Richards, M., Howard, C., Morehead, E., Geahr, M., Gluck, L., Hanlon, A., Ellis, B., Kaur, H., Simner, P., Carroll, K. C., & Mostafa, H. H. (2020). Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 127, 104384. https://doi.org/10.1016/j.jcv.2020.104384
Uhteg K, et al. Comparing the Analytical Performance of Three SARS-CoV-2 Molecular Diagnostic Assays. J Clin Virol. 2020;127:104384. PubMed PMID: 32361285.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays. AU - Uhteg,Katharine, AU - Jarrett,Junko, AU - Richards,Mahmia, AU - Howard,Craig, AU - Morehead,Elizabeth, AU - Geahr,Melissa, AU - Gluck,Linda, AU - Hanlon,Ann, AU - Ellis,Brandon, AU - Kaur,Harsimar, AU - Simner,Patricia, AU - Carroll,Karen C, AU - Mostafa,Heba H, Y1 - 2020/04/26/ PY - 2020/04/16/received PY - 2020/04/19/revised PY - 2020/04/21/accepted PY - 2020/5/4/pubmed PY - 2020/5/4/medline PY - 2020/5/4/entrez KW - COVID-19 KW - LOD KW - SARS-CoV-2 SP - 104384 EP - 104384 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J. Clin. Virol. VL - 127 N2 - In December 2019, a novel coronavirus (SARS-CoV-2) was first isolated from Wuhan city, China and within three months, the global community was challenged with a devastating pandemic. The rapid spread of the virus challenged diagnostic laboratories to rapidly develop molecular diagnostic methods. As SARS CoV-2 assays became available for testing on existing molecular platforms, laboratories devoted unprecedented energy and resources into evaluating the analytical performance of the new tests and in some cases developed their own diagnostic assays under FDA-EUA guidance. This study compares the validation of three different molecular assays at the Johns Hopkins Molecular Virology laboratory: the RealStar® SARS-CoV-2 RT-PCR, ePlex® SARS-CoV-2, and the CDC COVID-19 RT-PCR tests. Overall, our studies indicate a comparable analytical performance of the three assays for the detection of SARS-CoV-2. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32361285/Comparing_the_analytical_performance_of_three_SARS_CoV_2_molecular_diagnostic_assays_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30126-8 DB - PRIME DP - Unbound Medicine ER -