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

Nat Commun. 2021 Mar 26;12(1):1931. doi: 10.1038/s41467-021-22072-9.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 / epidemiology
  • COVID-19 / virology
  • COVID-19 Testing / methods*
  • Coronavirus Nucleocapsid Proteins / blood*
  • Coronavirus Nucleocapsid Proteins / genetics
  • Epidemics
  • Home Care Services
  • Humans
  • Point-of-Care Systems
  • ROC Curve
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / metabolism*
  • SARS-CoV-2 / physiology
  • Saliva / virology*
  • Specimen Handling / methods

Substances

  • Coronavirus Nucleocapsid Proteins