2020
DOI: 10.1093/jlb/lsaa069
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The promise of direct-to-consumer COVID-19 testing: ethical and regulatory issues

Abstract: 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 re… Show more

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Cited by 9 publications
(11 citation statements)
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“…It can also facilitate mass testing without the need for sanitary facilities and provide test results within a few minutes due to the recently developed rapid saliva tests 10 . However, SARS-CoV-2 self-testing does raise ethical concerns 28 . False negatives have the potential to cause harm, and false positives might produce psychological distress.…”
Section: Discussionmentioning
confidence: 99%
“…It can also facilitate mass testing without the need for sanitary facilities and provide test results within a few minutes due to the recently developed rapid saliva tests 10 . However, SARS-CoV-2 self-testing does raise ethical concerns 28 . False negatives have the potential to cause harm, and false positives might produce psychological distress.…”
Section: Discussionmentioning
confidence: 99%
“…Although EUAs provide welcome flexibility for commercial and laboratory developers, this approach also increases the risk that these tests could perform unexpectedly when deployed at scale in the field. For example, several poorly performing antigen tests were initially issued EUAs that were ultimately revoked, which required the FDA to independently evaluate these poor-quality tests and subsequently update its performance requirements and advice 104 , 105 .…”
Section: Ensuring the Integrity Of Testingmentioning
confidence: 99%
“…For example, our intelligence was valuable in anticipating and identifying tests with the potential to alleviate pressures on PCR-based resources and supply chains. We also supported the identification of ‘direct-to-consumer’ testing services for SARS-CoV-2 as part of a regulatory review, as the products and services remain controversial and pose ethical concerns on the grounds of the harm they may potentially cause to consumers [ 42 , 43 , 44 , 45 , 46 ]. This paper outlines key technological and regulatory trends for COVID-19 diagnostics and highlights key implications and challenges in this shifting health technology landscape.…”
Section: Introductionmentioning
confidence: 73%
“…The number of companies providing direct-to-consumer tests is growing around the world [ 43 , 110 , 111 ]. Tests for home blood collection and lab based-immunological tests (i.e., antibody tests), home-based saliva sampling for infection and genomic testing are marketed to consumers online or in stores [ 43 , 112 , 113 , 114 , 115 ]. We collected data on 73 providers offering 99 tests in the UK up until 16 October [ 116 , 117 , 118 ].…”
Section: Resultsmentioning
confidence: 99%
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