RADx Tech COVID-19 Test US Study

Rationale: Scalable, inexpensive point-of-care (PoC) technologies that enable detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus are desperately needed. However, understanding the accuracy and usability of novel PoC technologies for SARS-CoV-2 is critical. Each PoC test needs to be evaluated for its technical accuracy in laboratory settings and its intended populations and settings, and for its acceptability and usability in these contexts. In addition, how and when to use the PoC test and how to report test results need to be understood. 

Primary Objective:
To test the accuracy of investigational, emerging diagnostic technologies in the intended population or setting (Table 1) compared to a standard comparator for diagnosing SARS-CoV- 2 infection. The primary outcome measures will be the sensitivity and specificity of the diagnostic device.