SARS-CoV-2 Nucleocapsid Plasma Antigen for Diagnosis and Monitoring of COVID-19
Autor: | Daniel Solis, Bryan A. Stevens, James L. Zehnder, Scott D. Boyd, Hannah Wang, Malaya K. Sahoo, Benjamin A. Pinsky, Mamdouh Sibai, Fumiko Yamamoto, Katharina Röltgen, Michelle Verghese, Catherine A. Hogan, ChunHong Huang |
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Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Clinical Biochemistry Logistic regression Sensitivity and Specificity Gastroenterology Article law.invention COVID-19 Testing Antigen law Diabetes mellitus Intensive care Internal medicine medicine Coronavirus Nucleocapsid Proteins Humans Respiratory system Nucleocapsid Antigens Viral Immunoassay SARS-CoV-2 business.industry Biochemistry (medical) COVID-19 Electrochemical Techniques AcademicSubjects/SCI01290 Phosphoproteins medicine.disease Intensive care unit Hospitalization Luminescent Measurements AcademicSubjects/MED00530 AcademicSubjects/SCI00980 business AcademicSubjects/MED00690 |
Zdroj: | Clinical Chemistry |
ISSN: | 1530-8561 0009-9147 |
Popis: | 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. |
Databáze: | OpenAIRE |
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