@article{56b6652de5a04b848cfb340d4b1d3507,
title = "The impact of COVID-19 pandemic on technologic and process innovation in point-of-care diagnostics for sexually transmitted infections",
abstract = "The STI diagnostic landscape of FDA cleared tests for use at point-of-care (POC), as well as those emergency use authorized for COVID-19 are reviewed; some of these COVID-19 diagnostics may have platform potential as STI diagnostics. Finally, process innovation is described with self-collection and hub-and-spoke mail-in to reference lab models. Movement of Clinical Laboratory Improvement Amendments (CLIA)-waived POC tests to over-the-counter formats will make tests more accessible to consumers. Together with public health messaging, these measures could accelerate STI and COVID-19 syndemic diagnostic solutions.",
keywords = "COVID-19, Diagnostics, Point-of-care, STI, Sexually transmitted infections",
author = "Manabe, \{Yukari C.\}",
note = "Funding Information: The COVID-19 pandemic also uncovered the limitations to public health testing for emerging infectious diseases through federal and state labs. By May 2020, the private sector was performing the majority of COVID-19 testing in the US. The National Academies of Sciences, Engineering, and Medicine consensus report highlights that the “COVID-19 pandemic has exposed weaknesses in public health preparedness due to weak infrastructure, an under-capacitated and under-resourced workforce, and limited surge capacity.” [13] Multiple parallel efforts to bring more diagnostic tests and innovation to the market occurred; the Rapid Acceleration of Diagnostics (RADx) Tech program [14,15] was funded by Congress to the National Institutes of Health to accelerate diagnostic test development, Food and Drug Administration (FDA) emergency use authorization (EUA), and commercialization. Funding Information: The author would like to thank Mark Bobrow, Johan Melendez, and Charlotte Gaydos for their helpful review of the tables for this manuscript. YCM receives salary support for STI and COVID-19 diagnostic research from the National Institutes of Health (U54EB007958, 3U54EB007958-12S1, 3U54HL143541-02S2, UM1AI068613, and 6 U01PS005204-01-01). The views expressed in this manuscript are those of the author and do not necessarily represent the views of the National Institute of Biomedical Imaging and Bioengineering; the National Heart, Lung, and Blood Institute; the National Institutes of Health, or the U.S. Department of Health and Human Services. Publisher Copyright: {\textcopyright} 2021 The Canadian Society of Clinical Chemists",
year = "2023",
month = jul,
doi = "10.1016/j.clinbiochem.2021.11.003",
language = "English (US)",
volume = "117",
pages = "75--83",
journal = "Clinical Biochemistry",
issn = "0009-9120",
publisher = "Elsevier Inc.",
}