2183 SARS-CoV-2 Rapid Antigen Test

There are two device studies under the 2183 banner. The 2183b study uses an enhanced visual display compared to the original study (2183a), so it has been renamed. These prospective clinical studies seek to examine the performance of the 2183 device (a and b), a lateral flow immunoassay for the point-of-care (POC) detection of SARS-CoV-2 nucleocapsid protein antigen, compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. The goal of the 2183b study is for EUA approval for the device to be used among symptomatic persons by trained healthcare personnel collected mid-turbinate specimens. Note: no device performance data will be included in the data files.