TY - JOUR
T1 - Comparison of the analytical sensitivity of seven commonly used commercial SARS-CoV-2 automated molecular assays
AU - Mostafa, Heba H.
AU - Hardick, Justin
AU - Morehead, Elizabeth
AU - Miller, Jo Anne
AU - Gaydos, Charlotte A.
AU - Manabe, Yukari C.
N1 - Funding Information:
We thank the entire Medical Microbiology division for their assistance with this study. We also thank BioRad Laboratories for their collaboration. Funding: UM1-AI068613 (NIH, USA), U54EB007958 (NIH, USA), Center Of Excellence for Influenza Research and Surveillance (CEIRS, NIH, USA).
Publisher Copyright:
© 2020 The Author(s)
PY - 2020/9
Y1 - 2020/9
N2 - The SARS-CoV-2 pandemic has challenged molecular microbiology laboratories to quickly implement and validate diagnostic assays and to expand testing capacity in a short timeframe. Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. Several studies reported the analytical and/ or clinical evaluation of these molecular assays, however differences in the viral materials used for these evaluations complicated direct comparison of their analytical performance. In this study, we compared the analytical sensitivity (lower limit of detection, LOD) of seven commonly used qualitative SARS-CoV-2 molecular assays: the Abbott Molecular RealTime SARS-CoV-2 assay, the NeuMoDx™ SARS-CoV-2 assay, the Roche Cobas®SARS-CoV-2 assay, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2 assay, the Xpert Xpress SARS-CoV-2 test, and the GenMark ePlex SARS-CoV-2 test. The comparison was performed utilizing a single positive clinical specimen that was serially diluted in viral transport media and quantified by the EUA approved SARS-CoV-2 droplet digital PCR (ddPCR) assay. Replicate samples were prepared and evaluated for reproducibility across different molecular assays with multiple replicates per assay. Our data demonstrated that the seven assays could detect 100 % of replicates at a nucleocapsid gene concentration of (N1 = 1,267 and N2 = 1,392) copies/mL. At a one log less concentration, the Abbott, the Roche, and the Xpert Xpress assays detected 100 % of the tested replicates.
AB - The SARS-CoV-2 pandemic has challenged molecular microbiology laboratories to quickly implement and validate diagnostic assays and to expand testing capacity in a short timeframe. Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. Several studies reported the analytical and/ or clinical evaluation of these molecular assays, however differences in the viral materials used for these evaluations complicated direct comparison of their analytical performance. In this study, we compared the analytical sensitivity (lower limit of detection, LOD) of seven commonly used qualitative SARS-CoV-2 molecular assays: the Abbott Molecular RealTime SARS-CoV-2 assay, the NeuMoDx™ SARS-CoV-2 assay, the Roche Cobas®SARS-CoV-2 assay, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2 assay, the Xpert Xpress SARS-CoV-2 test, and the GenMark ePlex SARS-CoV-2 test. The comparison was performed utilizing a single positive clinical specimen that was serially diluted in viral transport media and quantified by the EUA approved SARS-CoV-2 droplet digital PCR (ddPCR) assay. Replicate samples were prepared and evaluated for reproducibility across different molecular assays with multiple replicates per assay. Our data demonstrated that the seven assays could detect 100 % of replicates at a nucleocapsid gene concentration of (N1 = 1,267 and N2 = 1,392) copies/mL. At a one log less concentration, the Abbott, the Roche, and the Xpert Xpress assays detected 100 % of the tested replicates.
KW - COVID-19
KW - LOD
KW - SARS-CoV-2
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U2 - 10.1016/j.jcv.2020.104578
DO - 10.1016/j.jcv.2020.104578
M3 - Article
C2 - 32777761
AN - SCOPUS:85089088786
SN - 1386-6532
VL - 130
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
M1 - 104578
ER -