The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues.
The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues.
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DOI：
10.1093/jlb/lsaa069
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发表时间：
2020-01
影响因子：
3.4
通讯作者：
Wexler A
中科院分区：
文献类型：
--
作者：
Kalokairinou L;Zettler PJ;Nagappan A;Kyweluk MA;Wexler A
广泛的诊断和血清学（抗体）检测是缓解 COVID-19 大流行的关键之一。虽然最初，美国的大多数 COVID-19 诊断测试都是在医疗机构中进行，但很快，直接面向消费者 (DTC) 的测试市场也出现了。在这些 DTC 提供模型中，测试由消费者发起，样品采集在家里或商业实验室进行。尽管提供 DTC 检测具有潜在的好处，例如扩大检测范围并降低消费者和医务人员的暴露风险，但它也引起了重大的道德和监管问题。本文回顾了这些挑战，并展示了它们与 DTC 健康测试领域先前提出的担忧有何相似之处和不同之处。本文的第一部分概述了 COVID-19 的诊断和血清学检测的概况，并预测了未来供应模式可能如何发展。第二部分讨论 DTC COVID-19 测试的五个主要问题：测试准确性；对结果的潜在误解；误导性声明和其他错误信息；隐私问题；以及稀缺资源的公平分配。最后，我们向监管机构和公司提出了建议，旨在确保以合乎道德的方式营销 DTC COVID-19 检测。
Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits—such as expanding access to testing and reducing the risk of exposure for consumers and medical personnel—it also raises significant ethical and regulatory concerns. This article reviews these challenges and shows how they parallel and also diverge from prior concerns raised in the DTC health testing arena. The first part of this paper provides an overview of the landscape of diagnostic and serological tests for COVID-19, anticipating how provision models are likely to evolve in the future. The second part discusses five primary issues for DTC COVID-19 tests: test accuracy; potential misinterpretation of results; misleading claims and other misinformation; privacy concerns; and fair allocation of scarce resources. We conclude with recommendations for regulators and companies that aim to ensure ethically marketed DTC COVID-19 tests.
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