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Quantifying SARS-CoV-2 nucleocapsid antigen in oropharyngeal swabs using single molecule array technology.
Olsen, Dorte Aa; Brasen, Claus L; Kahns, Søren; Madsen, Jeppe B; Kierkegaard, Helene; Christensen, Henry; Jensen, Anders; Sydenham, Thomas V; Møller, Jens K; Madsen, Jonna S; Brandslund, Ivan.
  • Olsen DA; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark. dorte.aalund.olsen@rsyd.dk.
  • Brasen CL; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark. dorte.aalund.olsen@rsyd.dk.
  • Kahns S; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Madsen JB; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Kierkegaard H; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Christensen H; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Jensen A; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Sydenham TV; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Møller JK; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
  • Madsen JS; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Brandslund I; Department of Biochemistry and Immunology, Lillebaelt Hospital, University Hospital of Southern Denmark, Vejle, Denmark.
Sci Rep ; 11(1): 20323, 2021 10 13.
Article in English | MEDLINE | ID: covidwho-1467136
ABSTRACT
This study aimed to develop a highly sensitive SARS-CoV-2 nucleocapsid antigen assay using the single molecule array (Simoa) technology and compare it with real time RT-PCR as used in routine clinical practice with the ambition to achieve a comparative technical and clinical sensitivity. Samples were available from 148 SARS-CoV-2 real time RT-PCR positive and 73 SARS-CoV-2 real time RT-PCR negative oropharyngeal swabs. For determination of technical sensitivity SARS-CoV-2 virus culture material was used. The samples were treated with lysis buffer and analyzed using both an in-house and a pre-commercial SARS-CoV-2 nucleocapsid antigen assay on Simoa. Both nucleocapsid antigen assays have a technical sensitivity corresponding to around 100 SARS-CoV-2 RNA molecules/mL. Using a cut-off at 0.1 pg/mL the pre-commercial SARS-CoV-2 nucleocapsid antigen assay had a sensitivity of 96% (95% CI 91.4-98.5%) and specificity of 100% (95% CI 95.1-100%). In comparison the in-house nucleocapsid antigen assay had sensitivity of 95% (95% CI 89.3-98.1%) and a specificity of 100% (95% CI 95.1-100%) using a cut-off at 0.01 pg/mL. The two SARS-CoV-2 nucleocapsid antigen assays correlated with r = 0.91 (P < 0.0001). The in-house and the pre-commercial SARS-CoV-2 nucleocapsid antigen assay demonstrated technical and clinical sensitivity comparable to real-time RT-PCR methods for identifying SARS-CoV-2 infected patients and thus can be used clinically as well as serve as a reference method for antigen Point of Care Testing.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronavirus Nucleocapsid Proteins / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: Europa Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-99807-7

Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronavirus Nucleocapsid Proteins / SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Prognostic study Limits: Humans Country/Region as subject: Europa Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-99807-7