Ultra-Sensitive Immunoassay Test for Quantitation of SARS-CoV-2 Antigen

Background: The 5534 prospective clinical study sought to examine the performance of the 5534 device for the detection of SARS-CoV-2 nucleocapsid protein antigen compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. Materials/Methods: The Simoa SARS-CoV-2 N Protein Antigen Test was tested for sensitivity and specificity in the detection of SARS-CoV-2 nucleocapsid protein antigen in the acute phase of infection. Outcome/Impact: The study outcome allowed for the Emergency Use Authorization (EUA) approval for the device to use among symptomatic persons by trained healthcare personnel collecting nasal, saliva, and dried blood spot samples.