Dataset from 2183 SARS-CoV-2 Rapid Antigen Test

Background: The purpose of this study was to conduct clinical trials on multiple new diagnostic devices in diverse populations and settings in the United States using a platform trial design. Specifically, these prospective clinical trials sought to validate devices used in the detection of SARS-CoV-2.

Materials/Methods: Performance was examined 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. Testing was done to determine the percent positive (sensitivity) and percent negative (specificity) agreement of the device in detecting COVID-19 (or SARS CoV-2) in symptomatic and asymptomatic people of all ages. No device performance data were included in the data files. Clinical questionnaires and surveys were administered to the participants.

Outcome/Impact: The outcome was for Emergency Use Authorization (EUA) approval for the 2183 device to be used among symptomatic persons by trained healthcare personnel that collected specimens for SARS CoV-2 detection.