The Shift to Over-the-Counter Diagnostic Testing After RADx: Clinical, Regulatory, and Societal Implications

Abstract

The National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) program answered the call to accelerate the development of point-of-care (POC) and over-the-counter (OTC) COVID-19 tests. The widespread availability and access to self-tests has increased the public's familiarity and acceptance of at-home diagnostics. This paper examines the current state of OTC diagnostic testing, discusses potential applications of OTC testing, and highlights the implications of widespread OTC testing for clinical medicine.

Keywords

• Diagnostics
• in vitro diagnostics
• OTC
• point of care
• viral testing