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SARS-CoV-2 Nucleocapsid Plasma Antigen for Diagnosis and Monitoring of COVID-19.
Wang, Hannah; Hogan, Catherine A; Verghese, Michelle; Solis, Daniel; Sibai, Mamdouh; Huang, ChunHong; Röltgen, Katharina; Stevens, Bryan A; Yamamoto, Fumiko; Sahoo, Malaya K; Zehnder, James; Boyd, Scott D; Pinsky, Benjamin A.
  • Wang H; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Hogan CA; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Verghese M; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Solis D; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Sibai M; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Huang C; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Röltgen K; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Stevens BA; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Yamamoto F; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Sahoo MK; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Zehnder J; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Boyd SD; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
  • Pinsky BA; Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
Clin Chem ; 68(1): 204-213, 2021 12 30.
Article in English | MEDLINE | ID: covidwho-1450383
ABSTRACT

BACKGROUND:

Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antigen in blood has been described, but the diagnostic and prognostic role of antigenemia is not well understood. This study aimed to determine the frequency, duration, and concentration of nucleocapsid antigen in plasma and its association with coronavirus disease 2019 (COVID-19) severity.

METHODS:

We utilized an ultrasensitive electrochemiluminescence immunoassay targeting SARS-CoV-2 nucleocapsid antigen to evaluate 777 plasma samples from 104 individuals with COVID-19. We compared plasma antigen to respiratory nucleic acid amplification testing (NAAT) in 74 individuals with COVID-19 from samples collected ±1 day of diagnostic respiratory NAAT and in 52 SARS-CoV-2-negative individuals. We used Kruskal-Wallis tests, multivariable logistic regression, and mixed-effects modeling to evaluate whether plasma antigen concentration was associated with disease severity.

RESULTS:

Plasma antigen had 91.9% (95% CI 83.2%-97.0%) clinical sensitivity and 94.2% (84.1%-98.8%) clinical specificity. Antigen-negative plasma samples belonged to patients with later respiratory cycle thresholds (Ct) when compared with antigen-positive plasma samples. Median plasma antigen concentration (log10 fg/mL) was 5.4 (interquartile range 3.9-6.0) in outpatients, 6.0 (5.4-6.5) in inpatients, and 6.6 (6.1-7.2) in intensive care unit (ICU) patients. In models adjusted for age, sex, diabetes, and hypertension, plasma antigen concentration at diagnosis was associated with ICU admission [odds ratio 2.8 (95% CI 1.2-6.2), P=.01] but not with non-ICU hospitalization. Rate of antigen decrease was not associated with disease severity.

CONCLUSIONS:

SARS-CoV-2 plasma nucleocapsid antigen exhibited comparable diagnostic performance to upper respiratory NAAT, especially among those with late respiratory Ct. In addition to currently available tools, antigenemia may facilitate patient triage to optimize intensive care utilization.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronavirus Nucleocapsid Proteins / COVID-19 Testing / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Clin Chem Journal subject: Chemistry, Clinical Year: 2021 Document Type: Article Affiliation country: Clinchem

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronavirus Nucleocapsid Proteins / COVID-19 Testing / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Topics: Long Covid Limits: Humans Language: English Journal: Clin Chem Journal subject: Chemistry, Clinical Year: 2021 Document Type: Article Affiliation country: Clinchem