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

Maren Downing; John Broach; Wilbur Lam; Yukari C. Manabe; Greg Martin; David McManus; Robert Murphy; Apurv Soni; Steven Schachter

doi:10.1109/OJEMB.2024.3512189

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

Maren Downing^*, John Broach, Wilbur Lam, Yukari C. Manabe, Greg Martin, David McManus, Robert Murphy, Apurv Soni, Steven Schachter

^*Corresponding author for this work

Medicine, Infectious Diseases Division

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Journal	IEEE Open Journal of Engineering in Medicine and Biology
DOIs	https://doi.org/10.1109/OJEMB.2024.3512189
State	Accepted/In press - 2024

Funding

This work was supported by the National Institute of Biomedical Imaging and Bioengineering under Grant 5U54EB015408-06, Grant 2U54EB007958-16, Grant 2U54EB027049, Grant U54EB027690, and Grant U54HL143541.

Keywords

Diagnostics
OTC
in vitro diagnostics
point of care
viral testing

ASJC Scopus subject areas

Biomedical Engineering

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10.1109/OJEMB.2024.3512189

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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.",

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AU - McManus, David

AU - Murphy, Robert

AU - Soni, Apurv

AU - Schachter, Steven

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AB - 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.

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

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