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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直接面向消费者的COVID-19测试的承诺：道德和法规问题

广泛的诊断和血清学（抗体）测试是缓解COVID-19大流行的关键之一。起初，美国大多数COVID-19诊断测试是在医疗机构中进行的，但很快就出现了直接面向消费者（DTC）的测试市场。在这些DTC供应模型中，测试是由消费者发起的，并且样品采集是在家中或在商业实验室中进行的。尽管提供DTC测试具有潜在的好处，例如扩大了测试的访问范围并降低了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法规关注。本文回顾了这些挑战，并说明了这些挑战如何与DTC健康测试领域中提出的先前问题相提并论。本文的第一部分概述了COVID-19的诊断和血清学检测的情况，并预测了将来提供模型的发展趋势。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；误导性主张和其他错误信息；隐私问题；公平分配稀缺资源。最后，我们向旨在确保符合道德的DTC COVID-19测试市场的监管机构和公司提供建议。公平分配稀缺资源。最后，我们向旨在确保符合道德的DTC COVID-19测试市场的监管机构和公司提供建议。公平分配稀缺资源。最后，我们向旨在确保符合道德的DTC COVID-19测试市场的监管机构和公司提供建议。