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N-protein presents early in blood, dried blood and saliva during asymptomatic and symptomatic SARS-CoV-2 infection.
Shan, Dandan; Johnson, Joseph M; Fernandes, Syrena C; Suib, Hannah; Hwang, Soyoon; Wuelfing, Danica; Mendes, Muriel; Holdridge, Marcella; Burke, Elaine M; Beauregard, Katie; Zhang, Ying; Cleary, Megan; Xu, Samantha; Yao, Xiao; Patel, Purvish P; Plavina, Tatiana; Wilson, David H; Chang, Lei; Kaiser, Kim M; Nattermann, Jacob; Schmidt, Susanne V; Latz, Eicke; Hrusovsky, Kevin; Mattoon, Dawn; Ball, Andrew J.
  • Shan D; Quanterix Corporation, Billerica, MA, USA.
  • Johnson JM; Quanterix Corporation, Billerica, MA, USA.
  • Fernandes SC; Quanterix Corporation, Billerica, MA, USA.
  • Suib H; Quanterix Corporation, Billerica, MA, USA.
  • Hwang S; Quanterix Corporation, Billerica, MA, USA.
  • Wuelfing D; Quanterix Corporation, Billerica, MA, USA.
  • Mendes M; Quanterix Corporation, Billerica, MA, USA.
  • Holdridge M; Quanterix Corporation, Billerica, MA, USA.
  • Burke EM; Quanterix Corporation, Billerica, MA, USA.
  • Beauregard K; Quanterix Corporation, Billerica, MA, USA.
  • Zhang Y; Quanterix Corporation, Billerica, MA, USA.
  • Cleary M; Quanterix Corporation, Billerica, MA, USA.
  • Xu S; Quanterix Corporation, Billerica, MA, USA.
  • Yao X; Quanterix Corporation, Billerica, MA, USA.
  • Patel PP; Quanterix Corporation, Billerica, MA, USA.
  • Plavina T; Quanterix Corporation, Billerica, MA, USA.
  • Wilson DH; Quanterix Corporation, Billerica, MA, USA.
  • Chang L; Quanterix Corporation, Billerica, MA, USA.
  • Kaiser KM; Institute of Innate Immunity, University of Bonn, Bonn, Germany.
  • Nattermann J; Institute of Innate Immunity, University of Bonn, Bonn, Germany.
  • Schmidt SV; German Center for Infection Research (DZIF), Bonn, Germany.
  • Latz E; Department of Internal Medicine I, University of Bonn, Bonn, Germany.
  • Hrusovsky K; Department of Internal Medicine I, University of Bonn, Bonn, Germany.
  • Mattoon D; German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany.
  • Ball AJ; Quanterix Corporation, Billerica, MA, USA.
Nat Commun ; 12(1): 1931, 2021 03 26.
Article in English | MEDLINE | ID: covidwho-1152851
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Saliva / Coronavirus Nucleocapsid Proteins / COVID-19 Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-021-22072-9

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Saliva / Coronavirus Nucleocapsid Proteins / COVID-19 Testing / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2021 Document Type: Article Affiliation country: S41467-021-22072-9