Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays

Katharine Uhteg; Junko Jarrett; Mahmia Richards; Craig Howard; Elizabeth Morehead; Melissa Geahr; Linda Gluck; Ann Hanlon; Brandon Ellis; Harsimar Kaur; Patricia Simner; Karen C Carroll; Heba H Mostafa

doi:10.1016/j.jcv.2020.104384

Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays

J Clin Virol. 2020 Jun:127:104384. doi: 10.1016/j.jcv.2020.104384. Epub 2020 Apr 26.

Affiliations

¹ 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.
² 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.
³ 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.

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.

Keywords: COVID-19; LOD; SARS-CoV-2.

Publication types

Comparative Study
Validation Study

MeSH terms

Betacoronavirus / isolation & purification
Bronchoalveolar Lavage Fluid / virology
COVID-19
Coronavirus Infections / diagnosis*
Humans
Molecular Diagnostic Techniques / methods*
Molecular Diagnostic Techniques / standards
Nasopharynx / virology
Pandemics
Pneumonia, Viral / diagnosis*
RNA, Viral / isolation & purification*
Reagent Kits, Diagnostic / standards*
SARS-CoV-2
Sensitivity and Specificity

Substances

RNA, Viral
Reagent Kits, Diagnostic