Point-of-care and Home Use Influenza Diagnostics for Advancing Therapeutic and Public Health Strategies.

Abstract

Point-of-care (POC) antigen-based diagnostics for influenza that have been granted waived status since the Clinical Laboratory Improvement Amendments of 1988 (CLIA-waived) have been available commercially in the United States for the last 25 years. Improved sensitivity, molecular, CLIA-waived tests have entered the market in the last 10 years. More recently, a new generation of assay technologies authorized for home use and available for over-the-counter sale has been introduced primarily though Emergency Use Authorization pathways during the SARS-CoV-2 pandemic. While evidence for the clinical impact of waived and home use diagnostic technologies is limited, their emerging availability and capabilities carry promise for impact on influenza management. In this review, we discuss the regulatory aspects, history, and capabilities of POC and home use influenza diagnostics. We draw on specific examples from the COVID-19 pandemic to propose ways in which these technologies can advance diagnostic and therapeutic strategies and highlight areas of need for ongoing investigation.