Rapid Manufacturing Scale-up for Compact Point-of-Care EUA SARS-CoV-2 RT-PCR Test

This prospective clinical study seeks to examine the performance of the device, a sample-to-answer nucleic acid PCR amplification platform solution for the point-of-care (POC) detection of SARS-CoV-2, compared to the Roche 6800 Cobas PCR for SARS-CoV-2 assay. Secondary outcomes include usability and interpretability of results among POC device operators. The goal of this study is to extend the existing EUA approval that the device has (symptomatic participants and healthcare provider obtained specimens) to use among asymptomatic persons and using self-collected mid-turbinate specimens. Note: no device performance data will be included in the dataset.