Discovery and Clinical Validation of Host Biomarkers of Disease Severity and Multi-system Inflammatory Syndrome in Children (MIS-C) and COVID-19

Background: This study aimed to develop novel approaches for early and accurate diagnosis of COVID-19 associated syndromes and evaluation of clinical severity and outcomes of COVID-19 disease in children.

Materials/Methods: The study collected nasal swabs and blood samples from pediatric patients with COVID-19 infection representing a broad spectrum of clinical severity across five hospital systems, to obtain viral whole-genome sequences from these samples, and to determine associations of infection by individual variants with COVID-19 disease severity in children by correlating the viral genomes with clinical, demographic, and laboratory metadata.

Outcome/Impact: This study identified RNA transcriptomic and cell-free DNA omics biomarkers that were used to develop and validate host-based assays from nasal swabs and blood samples for regulatory submission for FDA Emergency Use Authorization (EUA).