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RADx之后向非处方诊断检测的转变:临床、监管及社会影响

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

作者信息

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

机构信息

M Biomedical LLC McCormick SC 29835 USA.

School of MedicineUMass Chan Worcester MA 01655 USA.

出版信息

IEEE Open J Eng Med Biol. 2024 Dec 9;6:237-240. doi: 10.1109/OJEMB.2024.3512189. eCollection 2025.

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.

摘要

美国国立卫生研究院的快速诊断加速计划(RADx)响应了加速即时检测(POC)和非处方(OTC)新冠病毒检测开发的号召。自我检测的广泛可得性和可及性提高了公众对居家诊断的熟悉程度和接受度。本文审视了非处方诊断检测的现状,讨论了非处方检测的潜在应用,并强调了广泛的非处方检测对临床医学的影响。

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本文引用的文献

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Assessment of Reader Technologies for Over-the-Counter Diagnostic Testing.非处方诊断检测的读取技术评估
IEEE Open J Eng Med Biol. 2024 Jan 24;5:210-215. doi: 10.1109/OJEMB.2024.3355701. eCollection 2024.
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Over-the-counter and direct-to-consumer testing for Group A streptococcus.A 组链球菌的非处方和直接面向消费者检测。
Clin Biochem. 2023 Jul;117:34-38. doi: 10.1016/j.clinbiochem.2022.04.003. Epub 2022 Apr 9.

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