Abstract
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 21 million people worldwide since August 16, 2020. Compared to PCR and serology tests, SARS-CoV-2 antigen assays are underdeveloped, despite their potential to identify active infection and monitor disease progression.
Methods: We used Single Molecule Array (Simoa) assays to quantitatively detect SARS-CoV-2 spike, S1 subunit, and nucleocapsid antigens in the plasma of patients with coronavirus disease (COVID-19). We studied plasma from 64 patients who were COVID-19 positive, 17 who were COVID-19 negative, and 34 prepandemic patients. Combined with Simoa anti-SARS-CoV-2 serological assays, we quantified changes in 31 SARS-CoV-2 biomarkers in 272 longitudinal plasma samples obtained for 39 patients with COVID-19. Data were analyzed by hierarchical clustering and were compared to longitudinal RT-PCR test results and clinical outcomes.
Results: SARS-CoV-2 S1 and N antigens were detectable in 41 out of 64 COVID-19 positive patients. In these patients, full antigen clearance in plasma was observed a mean ± 95% CI of 5 ± 1 days after seroconversion and nasopharyngeal RT-PCR tests reported positive results for 15 ± 5 days after viral-antigen clearance. Correlation between patients with high concentrations of S1 antigen and ICU admission (77%) and time to intubation (within 1 day) was statistically significant.
Conclusions: The reported SARS-CoV-2 Simoa antigen assay is the first to detect viral antigens in the plasma of patients who were COVID-19 positive to date. These data show that SARS-CoV-2 viral antigens in the blood are associated with disease progression, such as respiratory failure, in COVID-19 cases with severe disease.
Keywords: SARS-CoV-2; longitudinal plasma samples; serological; single molecule arrays; viral antigen.
【저자키워드】 SARS-CoV-2, serological, longitudinal plasma samples, single molecule arrays, viral antigen., 【초록키워드】 COVID-19, coronavirus disease, severe acute respiratory syndrome coronavirus 2, coronavirus, Biomarker, Respiratory failure, Infection, intubation, severe acute respiratory syndrome Coronavirus, anti-SARS-CoV-2, clinical outcomes, Antigen, Disease progression, Seroconversion, Viral, PCR, serological assays, nasopharyngeal, serology tests, Patient, ICU admission, Clustering, plasma, SARS-CoV-2 antigen, respiratory, serological, patients, Blood, nucleocapsid antigen, SARS-CoV-2 spike, Simoa, RT-PCR test, Concentration, S1 subunit, severe disease, hierarchical clustering, test results, Hierarchical, Viral antigen, acute respiratory syndrome, viral antigens, 95% CI, acute respiratory syndrome coronavirus, These data, COVID-19 case, positive result, molecule, positive, COVID-19 positive patients, clearance, MONITOR, nucleocapsid antigens, SARS-CoV-2 S1, N antigen, plasma sample, Combined, SARS-CoV-2 viral, analyzed, identify, detect, reported, detectable, changes in, statistically significant, quantified, COVID-19 negative, patients with COVID-19, 【제목키워드】 COVID-19, Profiling,