The role Rapid Acceleration of Diagnostics Tech continues to play in the Covid-19 pandemic and next steps

Rapid Acceleration of Diagnostics (RADx) Tech [1] is a National Institutes of Health (NIH)-funded program launched on 29 April 2020, to accelerate commercialization of novel lab-based, point-of-care, and home-based tests to diagnose infection with SARS-CoV-2, the virus that causes COVID-19. RADx Tech was implemented and coordinated by the Consortia for Improving Medicine with Innovation & Technology (CIMIT) in its role as the Coordinating Center for the Point-of-Care Technologies Research Network (POCTRN) in conjunction with the NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the four POCTRN Centers [2].

Described in 2020 as ‘at least a mini Manhattan Project’ by U.S. Senator Lamar Alexander, the then Chair of the Senate Committee on Health, Education, Labor, and Pensions [3], RADx Tech was conceived to be part of a three-pronged strategy, together with vaccines and therapeutics, designed to significantly reduce the impact of COVID-19. With an accelerated timeframe, extensive cross-government agency collaboration and information exchange, and a unique combination of best-business, academic, and investment practices, RADx Tech has proven to be a new and productive model for moving translational projects to the marketplace. Within eight months, RADx Tech product teams were shipping one million tests/day. As of October 2022, RADx Tech had supported dozens of product teams with a cumulative production capacity of 4 billion tests under 46 Food and Drug Administration Emergency Use Authorizations (EUA).

Considering that the public had never conducted self-testing at such a large scale, and to ensure that these unprecedented achievements in providing test kits to the country achieved the intended maximal impact on ending the pandemic, RADx Tech launched companion educational tools, called ‘When To Test’ [4] and ‘My COVID Toolkit’ [5], to educate the public on the optimal usage of test kits and the importance of mitigation strategies.

When To Test is comprised of two calculators – one for individuals and one for organizations – along with a comprehensive list of Frequently Asked Questions (FAQs) targeted to each user group and ‘playbooks’ to assist schools and organizations in establishing COVID-19 testing programs. My COVID Toolkit focuses on providing knowledge and tools to help people protect themselves and others, and to safely get back to everyday life.

The individual calculator is a decision-support tool for people without symptoms of COVID-19 that delivers recommendations based on how likely an individual is to get COVID-19 and spread it to other people. A user is guided through a short series of simple questions that cover the person’s location, vaccination status, mask-wearing habits, and contacts and social gatherings. Based on these behaviors and the prevalence of disease in the person’s location, the calculator suggests whether the person should consider COVID-19 testing, the risk of having or getting COVID-19, and the risk of spreading COVID-19. A link to the U.S. Centers for Disease Control and Prevention (CDC) Self-Testing Guidance assists people in getting an at-home COVID-19 test, how to use the test, and how to interpret and respond to the test result. FAQs in the individual calculator address COVID-19, mitigations, and testing. Topics include:

• What’s the difference between polymerase chain reaction (PCR) and antigen tests?

• How do virus variants affect testing?

• Does the calculator consider how well vaccines work against variants?

• How does mask-wearing affect my test recommendation?

• What is the difference between isolation and quarantine?

In addition to providing easy-to-understand answers, links are given to sites for additional information on the topic.

The organization calculator assists groups such as schools and businesses in developing a plan to minimize the spread of COVID-19 throughout their organization. A user answers a series of simple questions that cover the organization’s size, testing participation, vaccination status, rate of mask-wearing, contact tracing program, and location. Based on these inputs, the calculator determines the recommended screening testing frequency and cost of testing for various types of testing technologies. The frequency and cost of testing vary based on test performance, which is built into the calculator. Users can readily explore different mitigation strategies, such as changing the mask-wearing policy, to find out how those changes impact testing. Different strategies can be compared in side-by-side tables.

Advanced users of the organization calculator can adjust underlying assumptions used in the calculations such as vaccine effectiveness, mask efficiency, basic reproductive number (R₀), and test performance parameters. Each setting has a tooltip to explain the function and a video user guide is available. Implementation details and additional test details such as staffing requirements, equipment requirements (if needed), number of people isolated or quarantined, and pooled test options are also available. The website is designed to encourage users to learn about and explore options.

As with the individual calculator, the organization calculator provides FAQs on COVID-19, testing, and mitigations and adds FAQs on implementing a testing program. Implementation FAQs address topics such as:

• How do I know if I need to test at my organization at all?

• When can I stop testing?

• Where can I purchase the kind of test the calculator recommends?

• What do we do when someone tests positive?

• What are the reporting and confidentiality requirements for COVID-19 test results?

In addition, playbooks with detailed information are available for K-12 programs, testing implementation guidance, and laboratory pool testing.

Because COVID-19 is a highly contagious disease that is primarily transmitted when an infected person spreads airborne droplets containing the virus to other people, multiple mitigation strategies are essential to reduce the spread of COVID-19 including mask-wearing, social distancing, and vaccination.

The appropriate use of each mitigation strategy, and how they work in concert, is critically important in achieving an end to the pandemic. Consequently, the My COVID Toolkit website serves as a reliable and transparent source of information on COVID-19, highlighting mitigations such as mask wearing and social distancing, testing, as well as authorized treatments. My COVID Toolkit gives users the necessary information to make informed choices for their unique situation, whether going to work or school, doing everyday tasks like grocery shopping, planning their social life, or attending special events, such as weddings. Simple safety measures are explained that can reduce an individual’s risk of becoming infected and infecting others. The site also has information on available treatments, eligibility considerations for those treatments, and where and how to access treatment.

The widespread availability of accurate, fast, easy-to-use, and affordable test kits is an essential but not sufficient component for ending a pandemic. Therapeutics, vaccines, and complementary educational efforts to enable individuals to stay healthy and protect the health of others are critically important as well and must be developed as a coordinated effort among government, academia, and industry at the outset in the country’s response to future pandemics.

As a model for the rapid development of molecular diagnostics and subsequent platform diversification validated in the United States [6–9], the applicability of RADx Tech to the global aspects of pandemics and its potential integration into other related global efforts and how it can be scaled to be affordable and feasible on a global basis requires further evaluation. RADx Tech could be adapted and customized for pandemic-related needs in under-resourced areas and developing countries in light of their specific economic realities, health care delivery systems, and supply chain challenges, and for non-pandemic medical technology initiatives across medical disciplines. Considering that biotech startups often rely on corporate venture capital arms for funding [10], rather than traditional venture capitalists, the RADx Tech model offers an alternative with the initial funder represented by NIH [11]. Plans are underway, for example, to leverage the RADx Tech model to expedite the development of accessible COVID-19 diagnostic tests for all users, including those with vision or motor disabilities [12], as well as the development of diagnostic tests for monkeypox [13], and for ways to mitigate maternal mortality [14].

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Acknowledgments

The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Institute of Biomedical Imaging and Bioengineering; the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.

Additional information

Funding

This project has been funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Grant No. [U54EB015408].