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

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. The goal of the 5534 study was for EUA approval for the device to use among symptomatic persons by trained healthcare personnel collected nasal, saliva, and dried bloodspot specimens. Note: no device performance data were included in the dataset.