N-protein presents early in blood, dried blood and saliva during asymptomatic and symptomatic SARS-CoV-2 infection

Dandan Shan, Joseph M. Johnson, Syrena C. Fernandes, Hannah Suib, Soyoon Hwang, Danica Wuelfing, Muriel Mendes, Marcella Holdridge, Elaine M. Burke, Katie Beauregard, Ying Zhang, Megan Cleary, Samantha Xu, Xiao Yao, Purvish P. Patel, Tatiana Plavina, David H. Wilson, Lei Chang, Kim M. Kaiser, Jacob Nattermann, Susanne V. Schmidt, Eicke Latz, Kevin Hrusovsky, Dawn Mattoon and Andrew J. Ball ()
Additional contact information
Dandan Shan: Quanterix Corporation
Joseph M. Johnson: Quanterix Corporation
Syrena C. Fernandes: Quanterix Corporation
Hannah Suib: Quanterix Corporation
Soyoon Hwang: Quanterix Corporation
Danica Wuelfing: Quanterix Corporation
Muriel Mendes: Quanterix Corporation
Marcella Holdridge: Quanterix Corporation
Elaine M. Burke: Quanterix Corporation
Katie Beauregard: Quanterix Corporation
Ying Zhang: Quanterix Corporation
Megan Cleary: Quanterix Corporation
Samantha Xu: Quanterix Corporation
Xiao Yao: Quanterix Corporation
Purvish P. Patel: Quanterix Corporation
Tatiana Plavina: Quanterix Corporation
David H. Wilson: Quanterix Corporation
Lei Chang: Quanterix Corporation
Kim M. Kaiser: University of Bonn
Jacob Nattermann: University of Bonn
Susanne V. Schmidt: University of Bonn
Eicke Latz: University of Bonn
Kevin Hrusovsky: Quanterix Corporation
Dawn Mattoon: Quanterix Corporation
Andrew J. Ball: Quanterix Corporation

Nature Communications, 2021, vol. 12, issue 1, 1-8

Abstract: Abstract The COVID-19 pandemic continues to have an unprecedented impact on societies and economies worldwide. There remains an ongoing need for high-performance SARS-CoV-2 tests which may be broadly deployed for infection monitoring. Here we report a highly sensitive single molecule array (Simoa) immunoassay in development for detection of SARS-CoV-2 nucleocapsid protein (N-protein) in venous and capillary blood and saliva. In all matrices in the studies conducted to date we observe >98% negative percent agreement and >90% positive percent agreement with molecular testing for days 1–7 in symptomatic, asymptomatic, and pre-symptomatic PCR+ individuals. N-protein load decreases as anti-SARS-CoV-2 spike-IgG increases, and N-protein levels correlate with RT-PCR Ct-values in saliva, and between matched saliva and capillary blood samples. This Simoa SARS-CoV-2 N-protein assay effectively detects SARS-CoV-2 infection via measurement of antigen levels in blood or saliva, using non-invasive, swab-independent collection methods, offering potential for at home and point of care sample collection.

Date: 2021
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DOI: 10.1038/s41467-021-22072-9

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