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

Author

Listed:
  • 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
    German Center for Infection Research (DZIF))

  • Susanne V. Schmidt

    (University of Bonn)

  • Eicke Latz

    (University of Bonn
    German Center for Neurodegenerative Diseases (DZNE))

  • Kevin Hrusovsky

    (Quanterix Corporation)

  • Dawn Mattoon

    (Quanterix Corporation)

  • Andrew J. Ball

    (Quanterix Corporation)

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.

Suggested Citation

  • 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 Clea, 2021. "N-protein presents early in blood, dried blood and saliva during asymptomatic and symptomatic SARS-CoV-2 infection," Nature Communications, Nature, vol. 12(1), pages 1-8, December.
    • Handle: RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-22072-9
    DOI: 10.1038/s41467-021-22072-9
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