Skip to main content

Currently Skimming:

Rapid Expert Consultation on Self-Tests for Infectious Diseases: Lessons Learned from COVID-19
Pages 1-28

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 1...
... SCPR provides a forum for discussion of scientific, technical, and social issues relevant to public health emergency preparedness and response (PHEPR)
From page 2...
... However, it has also demonstrated notable challenges, many arising from the lack of a proactive and comprehensive strategy, with the feedback and flexibility needed for adaptive management as the disease, diagnostic tests, and public opinion evolved. This rapid expert consultation summarizes lessons learned from the COVID-19 pandemic for the future development and usage of self-tests for circulating infectious diseases and future outbreaks and pandemics.
From page 3...
... • Address research and evidence gaps -- Key questions remain about how self-tests, as one component of an overall testing strategy, can be designed, developed, and made available to improve equitable access and use, how they affect user behavior and disease transmission across various segments of the population, and how communications impact their uptake and usage. Introduction The COVID-19 pandemic has been transformational in accelerating progress in infectious disease diagnostics, including self-administered diagnostic tests, or self-tests, as a potentially critical public health tool.
From page 4...
... To carry out the rapid expert consultation, the National Academies convened a group of subjectmatter experts with expertise in communicable disease surveillance, laboratory capabilities, behavioral health, and public health. To supplement their own expertise, the authors consulted published literature and received input from several external sources, whose willingness to share their perspectives and expertise was essential to this work (see Acknowledgments)
From page 5...
... • Remove structural barriers: Enhance uptake of quality HIVST products with market intelligence and support in meeting regulatory requirements. SOURCE: Adapted from STAR Initiative, 2022 OTHER RAPID DIAGNOSTICS FOR INFECTIOUS DISEASES FDA has approved rapid diagnostic tests for malaria (BinaxNOW)
From page 6...
... COMPARATIVE PERFORMANCE OF SARS-COV-2 DIAGNOSTIC TESTS Decisions about development, authorization, distribution, and use of self-tests, such as antigen tests for SARS-CoV-2, require comparing their performance with that of other testing modalities, especially RT-PCR and viral culture, within the constraints of specific settings (e.g., considering the end users, the availability of labs and professional staff, the need for results within a specified time frame) and goals (e.g., detect infection or infectiousness)
From page 7...
... As with any kind of diagnostic test, a false negative antigen test result may result in a false sense of security that makes individuals less likely to adhere to infection control practices such as masking and social distancing, thus increasing the risk of transmission (Crozier et al., 2021, Woloshin et al., 2022)
From page 8...
... . All products available by virtue of EUA are posted on the FDA website.8 Although antigen tests made available under EUA during the COVID-19 pandemic have aided mitigation efforts, they have not been tested as rigorously as other types of diagnostic tests with full FDA approval.
From page 9...
... . Based on experiences with SARS-CoV-2 self-tests, the authors have identified the following considerations as critical to strategic planning for self-tests for infectious diseases and future outbreaks and pandemics.
From page 10...
... . The following considerations are critical to incorporate into future self-testing planning strategies: • Goals and benefits of self-testing • Use of self-testing in other settings beyond at-home testing • Disease-specific considerations and pathogen dynamics • Manufacturing and regulatory considerations • Implementation and human component considerations • Research and evidence gaps GOALS AND BENEFITS OF SELF-TESTING Before self-tests are deployed for future events, decisions will need to be made about the outcomes the program is intended to achieve -- are the goals to prevent further spread of infection, seek out early treatment and care, meet testing demand in outbreaks or surge events, and/or contribute to disease surveillance efforts?
From page 11...
... Thus, strategic planning for future surge events could benefit from modeling future demand, to determine the manufacturing capacity, stockpiles, and supply chain considerations, as well as workforce, needed to meet anticipated demand. Disease Surveillance It is important for future strategic planning to consider ways to address disease surveillance challenges that may arise as a result of large-scale self-testing.
From page 12...
... A United Kingdom study, which administered antigen tests to school children twice a week, found that more than 80 percent of positive self-tests result were confirmed by positive RT-PCR (Hughes et al., 2022)
From page 13...
... . Therefore, self-tests were used in such settings, especially when molecular testing has been unavailable and appropriate antigen testing-algorithms can be implemented to help increase accuracy and minimize the chance for false-negative results (CDC, 2022a; McKay et al., 2021; Nuzzo and Gronvall, 2021)
From page 14...
... IMPLEMENTATION AND HUMAN COMPONENT CONSIDERATIONS Accessibility of Self-Tests An advantage of self-tests, specifically antigen tests, is greater accessibility and lower cost than laboratory-based RT-PCR testing. To ensure broad and equitable access, it is important to consider routes of distribution, depending on priority populations (e.g., direct to consumer, workplace, through commercial partners vs.
From page 15...
... Recent survey data find that SARS-CoV-2 rapid antigen tests are used most commonly by people who are White, high-income (>$150,000) , and have a post-secondary education; they are used least frequently among people who are Black/African American, low-income, and have a high school education or less (Rader et al., 2022b)
From page 16...
... Interventions to Broaden Accessibility To broaden the availability of SARS-CoV-2 testing services, including access to self-tests, CDC initiated the following programs: the Increasing Community Access to Testing (ICATT) program supports no-cost COVID-19 testing for persons who are symptomatic, exposed, or at high-risk of severe disease by partnering with pharmacies and other testing facilities across the country; and the Operation Expanded Testing (OpET)
From page 17...
... . Later in the pandemic, CDC provided recommendations for quarantining after a negative antigen test in various clinical scenarios that were hard to interpret and difficult to access due to information that was spread across multiple webpages, was poorly summarized, and not entirely consistent (Woloshin et al., 2022)
From page 18...
... . These factors are important for guidance development that will impact a person's ability to understand the likelihood they may or may not have the infection being tested for even in the setting of a negative antigen test and whether additional action may be needed or recommended (e.g., repeat testing)
From page 19...
... Participant households, which were provided with test kits and access to the digital companion application, were offered the option to voluntarily report their test results, either excluding or including personally identifiable information. The results of the pilot support the feasibility of establishing an efficient, scalable pathway for the reporting of self-testing results to state public health systems.
From page 20...
... Secure and confidential reporting (or even aggregate, anonymous reporting in some settings) of self-test results to both health care providers and public health authorities can be improved by exploring and developing mechanisms to facilitate connecting individuals with medical care, so that self-testing can be incorporated into future surveillance strategies.
From page 21...
... Table 1 Examples of Research and Evidence Gaps for Self-Tests Topic Research and Evidence Gaps Goals and Benefits • Impact of self-testing on alleviating health system pressures during of Self-Testing case surges • Impact of self-tests on disease and public health outcomes • How self-testing fits into an overall testing and surveillance strategy of clinical testing, syndromic surveillance, wastewater surveillance, and other testing strategies for COVID-19 • Relationship between self-testing, infection control, and treatment. • Processes, reporting mechanisms, and standards for reporting self-test results to public health agencies and/or health care providers • Acceptability and perceived usefulness of self-tests by individuals Settings for Self- • How to detect community disease burden in the presence of Testing widespread self-test use with unreported results • Approaches to maximize benefits and address the costs and risks of self-testing programs in different congregate living settings Disease-Specific • Real-world performance of self-tests Considerations and • Ability to detect infection at various stages of disease Pathogen Dynamics • Ability to identify infectiousness • Ability to determine infectiousness Manufacturing and • Incentives, costs, and processes needed to develop, distribute, and Regulatory use self-tests • Mechanisms for rapid development, evaluation, and regulatory approval for future self-tests • Future self-testing technology and innovations Implementation and • Up-to-date information to inform the public about which tests are useful Human Component for specific variants, the timeframe for accurate testing in terms of varying incubation and contagiousness durations, and next steps after a positive or negative test result • Self-testing access and equity including system performance for equitable access outcomes • Impact of federal mass self-test distribution programs • Different testing strategies for distribution, access, and use of self-tests • Communications and guidance about when to take tests, how to interpret results (e.g., positive, negative, indeterminate)
From page 22...
... • Public perception on the role of self-tests in an outbreak response versus an endemic disease state • Procedures to ensure that communications enable individuals to understand the value and goals of testing programs, the capabilities of tests, and the practical implications of test results • Facilitators and barriers for reporting self-test results to public health agencies. Concluding Remarks Self-testing holds great promise for helping individuals, communities, and health care and public health systems manage infectious diseases and limit morbidity and mortality.
From page 23...
... 2022. Diagnostic accuracy of rapid antigen tests for COVID-19 detection: A systematic review with meta-analysis.
From page 24...
... update: FDA authorizes antigen test as first over-the-counter fully at-home diagnostic test for covid-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19 update-fda-authorizes-antigen-test-first-over-counter-fully-home diagnostic#:~:text=Today%2C%20the%20U.S.%20Food%20and,a%20surface%20with%20reactive%20molecule s (accessed July 25, 2022)
From page 25...
... 2021. Performance evaluation of serial SARS-CoV-2 rapid antigen testing during a nursing home outbreak.
From page 26...
... 2022a. Finding a needle in the haystack: Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic sars-cov-2 infection.
From page 27...
... https://www.gov.uk/government/publications/liverpool-covid-19-community-testing-pilot-interim-evaluation-report summary (accessed July 25, 2022) Woloshin, S., B
From page 28...
... We extend gratitude to the staff of the National Academies who contributed to the research, writing, and editing of this rapid expert consultation, in particular Lisa Brown, Matthew Masiello, Shalini Singaravelu, and Margaret McCarthy, and to our science writer, Anna Nicholson. The following individuals served as reviewers: Rick Bright, The Rockefeller Foundation; Emily Brunson, Texas State University; Andrew C


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.