National Covid-19 Testing & Tracing Action Plan - Update Report Time to Redouble Our Efforts on Covid-19 Testing - The ...
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National Covid-19 Update Report Testing & Tracing Time to Redouble Our Efforts on Action Plan Covid-19 Testing Embargoed until 12:01am EDT, Thursday, July 16, 2020 THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 1
Foreword This terrifying tragedy was not and is not inevi- table. America can function safely, even as we fight Covid-19. Other countries have shown that a better alternative is possible. But as we said in America faces an impending disaster. April – when we first released The Rockefeller Foundation’s National Covid-19 Testing Action The extraordinary scale of the Plan – testing is the only way out of our present Covid-19 crisis is evident in the disaster, and it will remain the case until a vaccine or effective therapeutics are widely available. growing deaths and economic losses When we were barely a month into this pan- the pandemic has wrought in every demic, we brought together scientists, industry, state. Devastated minority and technologists, economists, and Republicans and Democrats alike to formulate an action plan low-income families bore the brunt of to expedite the development of our nation’s widespread testing and tracing system. We those costs. As the virus tore across called for rapidly expanded diagnostic test- the country, it exposed the structural ing capacity from 1 million tests per week to 3 million tests per week by June, and to 30 million inequities that have underpinned tests per week by October. Today we’re at 4.5 million tests per week, but unfortunately it’s and undermined our economy taking far too long to get to 30 million tests per for decades. And it will only worsen week, and communities that most need them – low-income families, minorities, and highly during fall’s cold and flu season. vulnerable essential workers – find it most difficult to gain access, while elite institutions, companies, and enterprises seem to be able to access them on the private market. We need to urgently fix clinical diagnostic testing and accelerate the introduction of faster, cheaper, point-of-care screening tests to prepare for next flu season. Some say it’s impossible. Some say America has already given up. But we know it can be done, and we present here a renewed national action plan to help get there. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 2
Across the board, federal leadership and genu- The Rockefeller Foundation will invest an ine public-private partnership will be essential additional $50 million toward realizing the emer- to meeting three key needs identified in this gency requirements we outline in this updated updated plan. First, we need to massively plan. But make no mistake: this crisis demands scale up fast, cheap screening tests to identify immediate federal funding. Congress took a asymptomatic Americans who are currently first step by including $25 billion for testing infected. Today the country conducts almost in the Coronavirus Aid, Relief, and Economic zero such tests, and we need at least 25 mil- Security (CARES) Act. This plan requires another lion per week for schools, health facilities, and $75 billion as soon as possible, because tests essential workers to function safely. Teachers, should be free and accessible to all who need healthcare workers, grocery store workers: them – with extra effort to make sure low-income these are the real heroes of this crisis, and they and minority communities, those who are more should be able to support our country without financially vulnerable and critical institutions like the all-consuming fear that they’re jeopardizing nursing homes, schools, and community centers their lives or the lives of their loved ones. are supported, and that we address the sharp racial injustices and inequities that plague our Second, we need to dramatically reduce the country. This represents the single best invest- processing time for diagnostic tests, from the ment America could make in averting an even current 5-14 days to a 48-hour standard turn- more tragic and pending disaster. around time that every state and community should meet. Many businesses that are privately Today Covid-19 cases are spiking, and the contracting with lab companies already meet trajectory in much of America is rising rapidly. this standard. We propose a public-private In addition, we will soon enter a new cold and collaboration between government, lab com- flu season with potentially 100 million cases of panies, and scientists in order to alleviate the flu-like symptoms that stand to overwhelm our very basic constraints that are leading to these current testing capacity. Not only do we need extraordinary delays. to bend the curve of this epidemic; we need to provide America’s essential workers and Third, this reinvestment in testing must be tied children with a way to go about their work and to the basics of any pandemic response to lives more safely, so that critical institutions can really work: clear public health communications survive and function during this period of time. from trusted community leaders, and robust The only alternative is more large-scale lock- contact tracing and support for targeted isola- downs. The price of that is too high to pay when tion to reduce the contagion of the disease. we don’t have to, if we make smart, strategic, by Dr. Rajiv J. Shah, science-based investments now. President of The Rockefeller Foundation THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 3
Overview The nation is clearly falling short of the commitment, focus and initiative needed to defeat Covid-19. Infection rates are hitting record highs nationally and in more than a dozen southern and western states. Tests are still perilously hard to come by in regions where demand is surging. Testing bottlenecks persist in many of the nation’s labs. We lack central coordinating authorities even at the state level. In much of the country essential contact tracing systems are nascent at best. The public is still not united in its response to the lethal virus, with large numbers refusing to take precautionary steps and dubious over the need for more testing. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 4
Our failures in the fight against Covid-19 have We are now at nearly five times that level – highlighted our national weaknesses and a notable improvement but still not nearly vulnerabilities. We have 4% of the world's enough. We need to be honest: We have in no population but around a quarter of all global way prevailed over Covid-19, and our original WE HAVE 4% OF THE cases and all deaths. Infections are down to a plan underestimated the roadblocks to scaling WORLD'S POPULATION BUT AROUND A QUARTER OF mere trickle in most of Europe while surging to testing, the role of asymptomatic spreaders, ALL GLOBAL CASES AND record highs across the United States. and the acceptance of contact tracing. ALL DEATHS We can reverse this trend, and prevail over We need to redouble our efforts to combat Covid-19, only with a clear, concerted, national Covid-19 and achieve the aims we set out in our plan for testing, tracing and communications. first action plan, while also adjusting to new Leaving the fight up to a patchwork of indi- realities. vidual states, cities, businesses and school systems will not work. The national testing strategy we need will THE NATIONAL TESTING STRATEGY require the country to ramp up to where it can WILL REQUIRE THE COUNTRY TO RAMP In late April, The Rockefeller Foundation and administer at least five million diagnostic tests UP TO AT LEAST FIVE MILLION DIAGNOSTIC TESTS AND 25 MILLION its partners proposed the nation rally around and 25 million screening tests a week within SCREENING TESTS A WEEK WITHIN a bold but achievable goal of expanding our three months, with the acknowledgement that THREE MONTHS testing capacity from one to three million tests we will need still more than that. This must be per week by the middle of June and to 30 mil- combined with rigorous and extensive contact lion tests per week by the end of October. We tracing and supported isolation. also proposed a robust human-centric contact tracing program to ensure that those exposed Tests must be easily available to all our teach- to the disease self-isolate to stop the spread ers, students, essential workers, nurses and and that data be on positive cases be collected bus drivers – every American, free of charge. TESTS MUST BE EASILY AVAILABLE TO ALL OUR and shared across the country. Investing in the creation, delivery and adminis- TEACHERS, STUDENTS, tering of these tests will be far cheaper for the ESSENTIAL WORKERS, NURSES AND BUS DRIVERS – Successful implementation of this 1-3-30 Action nation than the incalculable fiscal and social EVERY AMERICAN, FREE OF Plan would allow the country to reopen and costs of another economic shutdown. CHARGE equip businesses, schools and institutions to detect and contain inevitable outbreaks so that they could remain open. The country then was administering an average of around 143,000 tests a day – or 1 million a week – with no appre- ciable sign of an increase in those numbers. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 5
We can hit these goals only with concerted We have made progress in many areas since national focus and attention. Congress needs The Rockefeller Foundation put out its initial to urgently approve the proposed additional report in April. $ $75 billion for testing as part of the next stim- ulus bill. Insurers and government agencies The country has delivered over 39 million tests CONGRESS NEEDS TO URGENTLY must also clarify how the country will pay for and is now averaging well over 600,000 tests APPROVE THE PROPOSED ADDITIONAL $75 BILLION FOR this widespread screening program as it is a day – or roughly 4.5 million tests a week. TESTING AS PART OF THE put in place town by town, business by busi- Success in exceeding the three-million-tests- NEXT STIMULUS BILL ness and school by school. We must assure a-week goal reflects a surge in testing capacity that sufficient support is flowing to the hard- and noteworthy strides in overcoming some est hit communities, many of them Black and of the barriers to the production, supply and Hispanic, which have been disproportionally hit distribution of test kits. It also shows increased by Covid-19. resolve at the local and state level to prioritize testing. THE COUNTRY HAS In addition, the administration needs to invoke DELIVERED OVER 39 MILLION TESTS AND IS the Defense Production Act or a similar federal The progress so far is also the fruit of increased NOW AVERAGING WELL OVER program to oversee and goad the production cooperation. The Rockefeller Foundation since 600,000 TESTS A DAY and distribution of mass quantities of fast, low- April has drawn together hundreds of data cost antigen tests. What we need to implement experts, medical professionals, epidemiolo- a mass screening program are simple, quick, gists, business executives, philanthropists and easy and inexpensive tests. These sort of tests government officials at both the federal, state are on the horizon, but getting them into the and local levels. We are in frequent contact hands of everyone who needs them – schools, with a number of governors’ offices. We have employers, health providers, public essential launched a pilot tracking and tracing system in THE PROGRESS SO FAR IS THE FRUIT OF INCREASED workers, vulnerable communities – will require Baltimore that holds national promise. COOPERATION the muscle that only the federal government can provide. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 6
The result of all this is a national network of like-minded specialists devoted to these principal aims: A dramatic expansion of The creation of local sys- our testing abilities, with tems to track infections a focus on tests to screen and alert those who may be asymptomatic individuals exposed The development of The need for better data reliable, simpler, faster tracking and dissemination and cheaper tests The delivery of these The launch of a national tests to the hardest-hit education campaign to communities build support for testing and other safety measure The establishment of a standard set of proto- cols to assist employers and schools to reopen successfully THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 7
But amid the promising signs – increased Getting to three million tests a week was testing, sharp declines in hospitalization and The inability of key federal essentially a framing exercise. Ramping up to fatality rates, the uptick in innovation and institutions like the CDC to a number 10 times that high and higher will cooperation – we still see infection rates rising. keep pace with the scale of require breakthroughs in testing technology; Just as disturbing is the realization that asymp- the pandemic vast improvements in delivery and logistics; tomatic people are spreading the disease at firmer commitments to test among compa- alarming rates – and perhaps at rates higher nies, schools and government officials; and a that currently understood. That, and the loom- Wavering resolve over stronger conviction among Americans that a ing specter of seasonal flu in the fall, mean we testing within many state robust national testing and tracing program is must strongly demand that we as a country capitals vital to our vanquishing the virus and getting come together to drastically scale up test- fully back to work. ing for the fall – especially for asymptomatic people. Public confusion over the It is one thing to reopen. Chief among our central role of effective test- ing and contact tracing many concerns are: It is quite another to remain open. Multiple barriers to devel- oping fast, cheap and easily Keeping America open and operating through administered tests the fall will require vigilance, adherence to prevention practices, and a commitment to a vast screening program built around tests of asymptomatic individuals to spot new out- Equity issues in the breaks in schools, factories, office, and at-risk distribution and availability populations across the country. Over this of tests next phase, The Rockefeller Foundation and its partners believe it is vital that government and like-minded organizations pool efforts to accomplish a range of critical goals. The need for wide agree- ment on who should be tested, and how frequently THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 8
To effectively combat Covid-19 and keep our economy running, policy makers, foundations Ensure diagnostic and screening Address the current crisis in plan, of which $25 billion was and the private testing is free and available to lab-based diagnostic testing appropriated in the CARES Act all Americans. Public and private through wartime like mea- for testing. At least another $2 sector must: health insurance are already man- sures by the federal and state billion is necessary to incentivize dated to cover diagnostic testing, governments, manufactur- test development and produc- but action is required to cover ers, laboratories, and others. tion, similar to the amounts being protocol-based screening tests Collective action is needed to spent on vaccine development. by employers along with further break the existing testing “log mandates for public and private jam” of tests so that results of insurance coverage. Congress diagnostics testing is reduced needs to approve the proposed from the current 2+days to less $75 billion in additional federal than two days nationwide. The funds to cover testing costs into Federal government should next year as well as to incentivize throw its full weight and massive test development and produc- funding behind expediting the tion. The benefits of the resulting production and distribution of reduction in illness, deaths, and diagnostic and screening tests, economic disruption from prevent- including, if necessary, through able outbreaks will far outweigh the Defense Production Act or the costs of widespread screen- other appropriate authorities. We ing tests or the burden on labs to proposed $100 billion for testing increase their turnaround times. through April 2021 in our initial THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 9
24H Create and implement test pro- Support the development and Create a broad-based national Improve the speed and effec- tocols for widespread screening deployment of appropriate, Covid-19 Communications tiveness of contact tracing at the testing of asymptomatic people convenient, accurate, affordable Coalition to develop and imple- local level and make self-isolation to keep our schools, workplaces and rapid antigen tests required ment ways to promote testing, and quarantining more practical and communities open. Screening for implementing screening test tracing and safety measures such with proper public support for tests are essential to detect and protocols. Screening tests should as masks and social distancing. lost wages and other necessary rapidly contain local Covid-19 point-of-service/point-of-care tests The coalition should include services. outbreaks. We urge the CDC, in costing $5 to $10 per test, with non-profits, community organizers partnership with the public health same-day turnaround for schools and alliances of faith leaders as community, to put forth risk-based and workplaces, and even faster well as governmental leadership specific protocols for screening turnaround for mobile testing in at the federal, state and city levels. tests for K-12 schools, universi- communities. Communication should be local- ties, workplaces, nursing homes, ized to for cultural awareness and vulnerable communities, and other linguistic adaptation. settings based on their individ- ual levels of risk and exposure. National testing capacity should expand to at least 30 million tests a week by November, including at least 25 million screening tests and Improve data infrastructure and 5 million diagnostic tests a week. reporting and expand the utiliza- tion of data to drive performance and improve decision-making. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 10
1 The virus has pivoted. of symptomatic individuals and contacts to get It is now more contagious and appears to be to this level. spreading more aggressively across large swaths of the country. Outbreaks across states will continue to get We must pivot as well. worse if we don't increase testing to suppress the virus and open safely. As of July 11, only Covid-19 Testing Since early April, when U.S. Covid-19 viral test- 14 states are doing enough testing to sup- ing had plateaued at 1.0 million tests per week, press the spread of the virus, while 26 states considerable progress has been made in test- are achieving mitigation. 12 states have such Resolve diagnostic ing but clearly not enough given the spread. significant testing shortfalls that the outbreak testing shortages and By the end of June testing had reached 3.5 million tests per week, and by mid-July, over is growing. implement widespread 4.5 million tests a week. Flattening the curve We are also seeing huge disparity among the screening testing will require going to at least 7 million tests per week just to reach mitigation. But bend- states, with some states moving fairly aggres- sively on testing, while entire regions lag far ing the curve for new cases to a much lower behind. Some outbreak states are increasing suppression level, which must be our focus, testing, just not nearly enough to keep up with will require at least 30 million tests per week, the epidemic growth. Many states are seek- including 25 million weekly screening tests of ing to ramp up testing but are constrained by asymptomatic individuals.1 Even higher levels commercial lab capacity and/or limited lab of testing may be needed to keep our work- availability of testing supplies. places, our schools, and our communities open. As of July 12, Massachusetts, New Jersey and New York – all states that had achieved dra- This can only be done through a concerted matic decreases in new cases – all had positive national effort. rates under 3%. At the same time states experi- encing overwhelming surges had positivity COVID-19 Canada, Australia, Germany, France and South levels well over 10%, including Arizona, Florida, Korea – countries that have most successfully and Texas, just to name a few. combated the coronavirus scourge – each achieved positivity rates less than 1.5%. 2 Positivity rates must be under 10% just to flat- 1 https://www.npr.org/sections/health- ten the curve and less than 1-3 % to bend the shots/2020/06/30/883703403/ as-coronavirus-surges-how-much-testing-does-your- curve toward suppression. With much higher state-need-to-subdue-the-virus outbreak rates, we need a lot more testing just 2 https://ourworldindata.org/coronavirus-testing THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 11
At least 30 million tests per week nation wide are required to safely open and keep open our workplaces and communities 3,4,5 Arizona Florida Mississippi South Carolina Texas Idaho Georgia Alabama Nevada Arkansas Utah Kansas Louisiana Iowa Oklahoma Tennessee California South Dakota North Carolina Indiana Wisconsin Nebraska Growth: More than 10% positivity indicates the Missouri Kentucky pandemic is not being contained Colorado Washington Ohio Mitigation: Less than 10% positives based on Oregon Virginia at least 8 million tests a week indicates the Pennsylvania Maryland pandemic is staying about the same Delaware North Dakota Wyoming New Mexico Suppression: Less than 3% positives based West Virginia on at least 30 million tests a week indicates most Minnesota Montana communities should be able to safely stay open Rhode Island Illinois Michigan Massachusetts 3 https://coronavirus.jhu.edu/testing/testing-positivity Puerto Rico Hawaii 4 https://www.npr.org/sections/health- New Hampshire shots/2020/06/30/883703403/ District of Columbia as-coronavirus-surges-how-much-testing-does-your-state- New Jersey need-to-subdue-the-virus Alaska 5 https://globalepidemics.org/wp-content/uploads/2020/06/ New York Connecticut key_metrics_and_indicators_v4.pdf Maine Vermont 0% 5% 10% 15% 20% 25% THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 12
The differences in testing In Arizona, the number New Jersey tells a very and outcomes are stark of positive cases more different story. One of across the country. than tripled over the the hardest hit states month of June, a span early on, with a total in which the number of more than 12,600 of tests administered deaths, New Jersey has weekly nearly doubled. seen a sharp decline in Arizona is now seeing new positive cases. The more than 3,500 new Covid-19 cases every state’s governor, Phil Murphy, has adhered to day on average, by far its highest numbers a phased plan for reopening built around a since the start of the pandemic. The state sharp increase in testing. The state was testing is also seeing a rise in the share of positive around 7,000 people a day on average in late cases, from 12.3% of tests at the start of June April, compared to around 20,000 a day by to 26.9% by mid-July – the highest rate in the mid-June. The state has resumed outdoor country. Health officials on June 9 reactivated dining while retaining sharp restrictions on the state’s hospital emergency plan to brace indoor dining. for a possible shortage of emergency beds. By the end of the month, the state’s inten- The rate of positive cases in New Jersey now sive-care capacity was at 90%.6 That makes hovers around 1.26, among the lowest in the Arizona one of the fastest growing hotspots in country, while its rate of testing, at nearly the country. 17,000 tests per 100,000 residents, puts it 5th highest in the country.8 The increase in positive cases in Arizona comes after Gov. Doug Ducey ended the The disparity by region in terms of the actual state’s stay-at-home restrictions in mid-May spread of Covid-19 is also striking. In the and loosened most restrictions on gyms, pools South, the percentage of tests coming back and restaurants. The famous hotels along positive – at just over 10% in late June – dou- the Grand Canyon’s South Rim are open and bled in just two weeks. By comparison, the accepting tourists. positive rate in the Northeast was at 1.7%, in the Midwest 3.8% and in the West 7.9%. The 6 https://www.newsweek.com/ Arizona has administered just 9,331 tests per sharp uptick in both the South and the West arizona-icu-91-percent-capacity-1-4-coronavirus- cases-positive-1515436 100,000 residents as of July 12, putting it has raised alarms over whether states are 7 https://coronavirus.jhu.edu/testing/ near the bottom of the list of states on testing reopening too swiftly without proper protocols states-comparison 8 https://coronavirus.jhu.edu/testing/ metrics.7 in place. states-comparison THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 13
Pay reasonably now or Diagnostic testing for Covid-19 is generally Equitable Testing Funding Recommendation pay exorbitantly later covered through public and private health insurance. But recent guidance from the Department of Health and Human Services People across the U.S. are being unequally and other federal agencies suggests that Providing the level of testing needed to keep exposed to the Covid-19. Latino and African screening testing may not be covered.9 our schools, workplaces, and communities American residents are three times as likely as Combined with the millions of Americans still safe from recurrent Covid-19 outbreaks will be their White counterparts to be infected with uninsured or underinsured, this lack of cov- costly, even with more affordable screening Covid-19 and almost two times as likely to erage will only prolong our battle against the tests. But the human, social, and economic die.10 These disparities are the result of struc- virus. Already people of color, the elderly, and costs of lockdowns, school closures, and tural racism that have overtly and covertly other vulnerable populations are suffering the recurrent surges will be far, far greater. placed essential services, like quality health greatest loss of life, disability, and economic care, beyond the reach of our Black and Brown hardship; the magnitude of these disparities Given the continued threat of Covid-19 communities. and impacts will only increase if we don’t have diagnostic and screening testing should be adequate testing to catch recurrent outbreaks available to everyone in the U.S. without cost The Rockefeller Foundation strongly recom- early. to the person receiving the test. Governments, mends that an additional $75 billion in federal health insurers and employers can pay a funds to cover the additional costs of test- reasonable price today by covering the cost ing and tracing as well as to incentivize test of both diagnostic and screening testing – or development and production. Federal funding over the coming months and years pay a far for testing and supportive services should be more exorbitant price as a result of a sluggish allocated in proportion to the burden of illness economy, excess healthcare costs, and the and disease that communities experience. In potential need for additional bailouts. The cost short, this funding should be used to prioritize of inadequate testing has already been vividly testing for racial and ethnic minorities who proven by the preventable loss of life and the are more likely to get sick and die of Covid-19 tremendous economic cost of the first pan- because of underlying conditions, jobs and demic wave. living situations with higher exposure risk, and inequitable access to quality healthcare. 9 https://www.cms.gov/files/document/FFCRA-Part- 43-FAQs.pdf 10 https://www.nytimes.com/interactive/2020/07/05/ us/coronavirus-latinos-african-americans-cdc-data. html THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 14
Screening Tests to keep our The pandemic coronavirus was deadly and Implementing large-scale screening will schools, workplaces, and debilitating to begin with but now appears require national commitment and resolve, as communities open even more contagious, thanks to a recent well as substantial added funding. The fed- mutation. More than 90% of Americans thus eral government should invoke the Defense far have avoided infection and remain vulner- Production Act or some similar authority to able. The virus is in nearly every part of the speed production. We will also need at least country, so recurrent outbreaks are inevitable $75 billion in additional funding to pay for without further steps to contain the virus. How the ramped-up testing. Implementation will many, how big and where these outbreaks require a standard set of protocols, a delinea- occur depends on what we do – or do not do – tion of use cases for specific testing settings, to protect ourselves from infection and rapidly and viral tests appropriate to the large variety detect new flare ups. Our solutions must be of different screening programs. more aggressive if we are going to prevail against this pandemic. Widespread testing to detect asymptom- atic individuals11 is crucial. This sort of mass screening enables early detection and rapid response to both individual cases and local outbreaks. The virus is already doing wide- spread damage if the first sign of trouble is an overflowing emergency room or a third of a warehouse’s or meat packer’s workforce out sick with coronavirus. 11 In this report the term “asymptomatic” is used to refer any individual who does not have symptoms or show signs of Covid-19 infection at the time of testing. This includes individuals who have not become infected with Covid-19, individuals who have become infected but will show symptoms during the course of their infections, and “pre-symptomatic individuals who are infected and will eventually experience Covid-19 symptoms. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 15
A Risk-Based Approach to Mitigation measures like masking, distancing, an effective screening test strategy in diverse Protocols for Workplace and and monitoring for symptoms help but have contexts around the country and considering Community Testing not been able to fully contain the spread of the limits of laboratory testing and the chang- the disease in the US, particularly among ing threat of the virus. essential workers and vulnerable populations. Timely testing of people with symptoms and A standardized set of protocols for testing is close contacts is a key part of the contain- needed to guide employers, schools, and other ment strategy. Laboratory (PCR) tests are the institutions as they reopen. Five months into gold standard for determining whether people the pandemic, the U.S. has not yet developed with symptoms that could be Covid-19 have specific enough guidelines that states and been infected with the virus, which triggers municipalities might emulate. This is also the the need for continued isolation and contact case for large-scale employers, public service tracing. Because close contacts are also at workers, schools, leading colleges and universi- high risk of infection, timely laboratory testing ties, nursing homes, and other at-risk settings. is needed for these individuals as well. In the absence of such guidance, large orga- In addition, significant Covid-19 spread has nizations are moving ahead with a dizzying occurred through people with no or minimal array of different reopening protocols, some symptoms; actual cases are estimated to be of which emphasize frequent testing, but ten times higher than reported cases, and the many others that don’t. Uniformity of stan- virus is increasingly present in communities dards is impossible, but a data-driven set across the nation. Consequently, screening of risk-based protocols would greatly assist tests among people who are asymptomatic administrators and managers establish prac- can help detect cases and contain the spread tices to spot potential outbreaks and keep of the pandemic in workplaces, schools, and organizations open. communities. For screening, point-of-care tests like antigen tests are needed, potentially Protocols are needed to use available tests along with pooled laboratory tests, to provide effectively in a wide range of employment, much greater testing capacity, speed, and school and community settings. The protocols convenience than can be achieved through should be easy to understand and imple- laboratory testing alone. To date, there has ment. They should reflect evidence-based been limited guidance on how to accomplish risk assessments of the characteristics of that this in a risk-based way that balances accu- setting, the capabilities of available tests, and racy, timing, and costs. Consequently, there is the actions required based on the tests. They little guidance available on how to implement should allow customization and should be THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 16
updated as newer tests come onto the market PROTOCOLS SHOULD CONSIDER and relevant evidence on disease transmission THE FOLLOWING: becomes available. Public policy should work Risk level of the setting (high, medium, low) to support these initiatives, including financial to set a transmission reduction goal and technical support, particularly at the local Testing strategies to accomplish level as hotspots develop. transmission reduction goals Processes for acting on the testing results RISK ASSESSMENT TESTING STRATEGY ACTIONABLE RESULTS Likelihood of infection Test Choice Confirmation > Accuracy Likelihood of onward transmission > Convenience Individual response > Time to results Consequences of transmission > Cost Environmental response Who and how often to test Public health notification Advanced strategies THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 17
Risk Assessment Testing Strategy Actionable Results Symptomatic individuals or people who have The goal of a testing strategy is to identify Protocols should also address how to support been in close contact with a person that has infected individuals to reduce onward trans- individuals during testing and how to act on tested positive should always follow CDC mission. Any strategy should include a choice results. Testing strategies that use less accu- guidance to isolate until they have been tested of a test or tests, and how to use them. Key rate tests may need to confirm positive results with a highly reliable test and been confirmed factors in test choice include accuracy of the with repeat testing or a more accurate test. negative. For asymptomatic screening, risks test and the time it takes to get the results, Procedures will also need to be in place to should be assessed over categories of people as Figure 2 illustrates, as well as cost and alert public health authorities about confirmed and workflows in a workplace, school, com- feasibility. cases, with mechanisms for notification and munity, or other setting, as shown in Figure 1. testing of close contacts. Supports may be This includes considering the risk of infection While clinical laboratory tests (rtRNA-PCR) required to help people quarantine until confir- in those coming in and out of the setting, are most accurate, they take time to send out matory test results are received, and to isolate which in turn depends on the risk level in and for the laboratories to run, and the clin- if they are infected. Communication and trust their communities. It also includes the risk of ical laboratory capacity available is far short are critical: protocols should be designed to transmission of the virus given the mitigation of that needed to support large-scale testing, be respectful and supportive of individual steps that are feasible and the severity of although pooled laboratory testing may be an concerns and should be clear about why the consequences of infection transmission in that option in some settings if sufficient capacity actions based on the test are important, to setting. More intensive testing will generally is available. Some emerging laboratory tests, maintain engagement in implementing the be optimal in settings that are high-risk; some for example based on CRISPR technology, may protocols effectively. This includes clear com- testing in settings that are medium risk; and no provide a broader option for screening tests in munication about isolation, cleaning and other testing in settings that are low risk. the months ahead in settings that can support mitigation procedures that are implemented rapid access to these laboratory tests, will when cases are detected. affect how fast an individual and their contacts are isolated from the rest of the population. While less sensitive (that is, they miss some cases), point-of-care tests have the advantage of convenience, speed, and potentially cost so support large-scale and timely testing. With broader use and faster time to results, this can lead to earlier detection and better contain- ment12 of outbreaks. 12 https://www.medrxiv.org/ content/10.1101/2020.06.22.20136309v2 THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 18
Advancing the Use of the Federal, state, and local governments, Effective Testing Protocols where employer action alone is likely to be insufficient. Early priority areas for protocol development include higher-risk and vulnera- The Rockefeller Foundation is committed to ble communities, nursing homes, and public advancing the use of effective testing pro- schools. tocols, including by increasing awareness, sharing, and collaboration on protocols in Especially in areas where Covid-19 has been use and in development To connect employ- prevalent and the risk of transmission and ers around the globe as they grapple with health consequences are high, communities the virus, The Rockefeller Foundation is part- need effective testing protocols to quickly nering with Arizona State University and the detect where outbreaks are emerging, with World Economic Forum to launch Covid-19 special strategies to work with high-risk Workplace Commons, an interactive website populations. This includes those living in that will 1) enable employer networking within low-income groups, small multigenerational and across industries around the globe and housing, and neighborhoods with many 2) support the implementation of best prac- essential workers. This also includes commu- tices in testing for workplace reopening. The nities of color as death rates among Black and website will include an interactive back-to- Hispanic/Latino people are much higher than work data dashboard that employers, policy for white people across all age categories. makers and the public can use to learn about Typical settings for community testing centers the types of testing and other safety proto- include shelters, housing complex, churches, cols employers are using to reopen and where community centers, and firehouses. Such these strategies are being deployed. The back- testing protocols should be fully aligned with to-work data dashboard will be populated with civil liberties, due process, non-discrimina- data from a global employer survey, admin- tion, data and health privacy protections, and istered to over 10,000 employers at multiple health ethics. timepoints over the coming year. Public agencies and community outreach Working with its Testing Strategy Group, groups are already using innovative strat- the Duke-Margolis Center for Health Policy, egies and key partnerships to improve and other expert advisors and partners, the testing for high risk communities. Dr. Jennifer Rockefeller Foundation will also support Avegno Director of the New Orleans Health awareness and development of protocols Department and the Community Organized in high-need areas from the standpoint of Relief Effort (CORE) are focusing on THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 19
hyper-mobile pop-up testing.13 Their approach undertaken and how it can be implemented PCR is designed to meet people where they are effectively. CDC recommends one-time “base- and reduce barriers to access particularly for line” laboratory testing of all nursing home people of color, low-income, first responders, residents, and CMS has further “strongly and essential workers. Dr. Jill Jim, Executive recommended” weekly testing for staff, plus Director of the Navajo Department of Health, testing of symptomatic workers and residents, and Dr. Laura Hammitt, Director of Infectious and close contacts of cases. Additional test- Disease Prevention Programs, at the at the ing of asymptomatic individuals may not only Johns Hopkins Center for American Indian help facilities detect and contain outbreaks ANTIGEN Health, with support from CORE, are increas- earlier, but also could support at least limited ing testing and contract tracing efforts linked relaxation of the “no visitor” policies that are to wrap-around services needed during isola- challenging for families and the well-being of tion for the Navajo population as they wait for residents. However, such laboratory testing is testing results or if they are confirmed to be very costly and thus hard to sustain for facili- infected.14 Eric Garcetti, Mayor of Los Angeles, ties that rely substantially on public funding for the LA Fire Department, CORE, and other col- their low-income residents, and the large num- laborators are scaling large testing sites and ber of laboratory tests required for nursing ANTIBODY maximizing testing capacity for the diverse Los home screening has strained testing capacity Angeles population, and are developing plans and contributed to overall testing delays. for access to testing of asymptomatic individu- als in high-risk neighborhoods.15 As a result of these challenges, there is sub- stantial variation in testing protocols among The impact of the pandemic in skilled nursing the states. New York state guidelines fea- facilities demonstrates that nursing homes ture stronger testing requirements: biweekly need effective testing protocols. Under 1% testing of all residents, staff, and others of the adult population lives in a skilled nurs- in contact with residents twice per week. ing facility over 40% of deaths in the United Nursing facilities have a range of options to States through June 2020 have been linked comply, including referring workers to local to these settings.16 These vulnerable popula- or state-sponsored testing sites or to contract 13 https://ready.nola.gov/incident/coronavirus/ city-partners-with-core-on-mobile-testing-site-in/ tions are served by staff that systemically face with a third party. Workers who test positive 14 https://www.jhsph.edu/Covid-19/articles/partners-in- disproportionate risks in their communities. must isolate for two weeks and are entitled to fighting-coronavirus-among-native-americans.html 15 https://www.businessinsider.com/ While there is clear agreement that ongoing paid sick leave. Nursing facilities that do not sean-penn-nonprofit-core-provides-coronavirus- testing is needed as an integral part of miti- comply can be fined up to $2000 per day. testing-in-los-angeles-2020-4 16 https://www.nytimes.com/interactive/2020/us/ gation strategies for skilled nursing facilities, The state of North Carolina, supported by CVS coronavirus-nursing-homes.html there is less clarity on what testing should be Health, has begun testing all residents and THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 20
Performance and cost characteristics: 108 Emergency Use Approved (EUA) viral RNA and Antigen tests 70% 85% 100% 0
staff, and is developing strategies for ongoing infections, and while evidence is limited on the testing. NCDHHS will also act as payer of last extent to which children without symptoms resort for all screening tests for those without spread the virus, the school environment cre- symptoms, removing a key barrier to such ates significant opportunities for spread. Thus, testing. This baseline testing is in addition to especially in communities where Covid-19 is screening tests in facilities where there is at prevalent, schools are potentially at high risk least one confirmed case of Covid. Rhode for experiencing significant clusters of cases Island has also prioritized testing all residents before detection occurs based on symptoms. and staff at all nursing homes in the state. Timely testing of asymptomatic or mini- Samples from residents were collected on mally staff and students could address these site while staff were sampled off-site. Nursing potentially large risks and help provide much- homes with active infections have been tested needed evidence to guide further protocol more frequently. Testing is occurring every development. But there are significant oper- four to seven days to minimize the possibility ational and cost challenges to implementing that pre-symptomatic and asymptomatic indi- testing in the school setting, and as a result, viduals can infect other individuals. the CDC’s general guidance on school reopen- ing recommends against universal screening Finally, effective testing protocols to support of all students. Given the high stakes of sus- schools have not been developed, even as tainable school reopening, The Rockefeller reopening dates approach and decisions Foundation is prioritizing collaborations with about whether and how to reopen schools leaders in education to address the role of are generating controversy and concern. testing in enabling safer and more confident Teachers, students, parents, and policymakers reopening. want reopening to occur not only because of the critical importance of education, but also because of the support that schools provide beyond classes, and the impact of school closure on work. At the same time, they are understandably concerned about the potential for undetected spread in schools, which could significantly worsen existing epidemic growth around the country and lead to school re-clos- ing and even more disruption. Most children with Covid-19 have asymptomatic or mild THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 22
MOST COUNTRIES THAT HAVE Protocols for schools, nursing homes, SUPPRESSED THE DISEASE AND ARE and vulnerable groups. REOPENING SCHOOLS HAVE INSTITUTED SCHOOL PROTOCOLS THAT INCLUDE: The Rockefeller Foundation is co-developing and supporting the implementation of data driven risk-based protocols on who to test, Reducing class size and increasing the with what frequency, under what conditions, physical distance between students in and with what type of test. While these pro- defined groups tocols are under development, and in lieu of other guidance, we recommend the follow- Staggered starts, stop, and ing interim measures. For nursing homes, we break times within the school endorse the CMS recommendation, includ- ing one-time “baseline” testing of all nursing Opened more for younger versus older students home residents as well as weekly screening tests for staff and workers, including employ- Required face masks for students and/or staff ees, contract staff, medical staff, operators in schools, with variability for lower ages and administrators. We suggest PCR-based diagnostic testing for symptomatic individuals Implemented systemic school-based and, particularly if timely PCR testing capac- testing at some level ity is limited, screening tests using pooled PCR tests or FDA-approved antigen tests for asymptomatic individuals. For K-12, we suggest at a minimum schools require students and staff to get tested as soon as possible after they develop one or more Covid-19 symp- toms or if one of their household members or non-household close contacts tested positive for Covid-19. Additional guidance is in devel- opment. These testing approaches should be paired with isolation and quarantine. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 23
WAITING CONSIDERING A RANGE What colleges are doing 2.7% 6% TO DECIDE OF SCENARIOS By September, some 20 million college stu- 8% PLANNING FOR ONLINE dents will either return to campus or be ready for another term of distance learning. As of early July, the vast majority of higher-ed institutes – just over 60% – are planning to resume with in-person PROPOSING A 22% HYBRID MODEL classes, with another 22% using a hybrid course model in which students can either take courses in person or online.17 Schools sticking with in-person classes are implementing detailed plans with the standard social distancing, wearing of masks, etc., com- bined with various apps that can track symptoms. But many also plan to rely on a robust test- ing and contact tracing network on campus. Ambitious plans have been set forth by institu- tions such as Purdue University, Notre Dame University, Indiana University, University of Florida, University of Texas at Austin and Boston PLANNING FOR University. All are calling for a comprehensive 61% IN-PERSON testing and tracing system to protect students and faculty. These systems will screen students upon their return and offer continual Covid-19 testing throughout the semester to guard against outbreaks. These schools, however, remain the outlier rather than the norm. Many other institu- tions appear reluctant to engage in large-scale testing due to cost concerns. Further, these schools might not be prepared for the signifi- cant number of positive student cases they may encounter at the outset of the semester. 17 https://www.chronicle.com/article/Here-s-a-List-of-Colleges-/248626?cid=wcontentgrid_hp_1b THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 24
What Companies Are Doing Delta Air Lines UnitedHealth Group & Microsoft Plans to test employees for active Covid-19 Both companies are utilizing a coronavirus and antibodies in partnership with the Mayo screening app, dubbed ProtectWell, with a Clinic and Quest Diagnostics. Will phase to daily symptom screener to clear employees cover all employees over time. to return to work or direct them to be tested for the virus. Amazon Will begin with a self-administered pilot Smithfield Foods Inc. testing program with an aim of testing all Offers free tests to all of its workers on a con- employees every two weeks. Plans to spend tinuing, voluntary basis $4 billion on Covid-19 -related expenses, including developing its own diagnostic labs. 10X Genomics Inc. Administering weekly diagnostic tests for Apple about 180 research, manufacturing, and Mandating temperate checks and providing other employees. They self-report results, optional nasal-swab tests to its employees. which arrive two to three days later. Walmart Wynn Resorts Considering diagnostic and antibody testing Partnering with University Medical Center of for its employees. Southern Nevada to provide free testing to all its Las Vegas employees, either at the work- General Motors place or a designated hospital Any employee who shows symptoms of Covid-19 at work will get a nose swab, which will then be sent to a nearby medial lab for rapid processing. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 25
Risk-based protocols need fast and affordable tests to prevail 24H against Covid-19 RAPID CONVENIENT The development and deployment of For screening testing to work effectively in Easily administered and analyzed outside of a simpler tests for employers, healthcare many situations, the speed of reporting, or clinical setting using a self-administered nasal providers, schools, at-risk settings like nursing turnaround time, may be more important than swab, toaster-sized analytic device, saliva, homes, hard-hit communities of color. sensitivity. Faster turnaround time means breathalyzer-type devices, antigen test strips, positive individuals can be removed imme- or other collection and analytic systems. The tests needed for mass screening must be: diately from a setting where transmission to others may occur. Thus, results should ideally be returned within 60 minutes but certainly within 12- 24 hours, for schools and work- places, and 30-60 minutes for mobile testing in communities. ACCURATE Medium (>70%) sensitivity with frequent testing (at least weekly) APPROPRIATE Rapid results mean earlier isolation, less spread while awaiting results, reduction in positive cases lost to follow-up and enable AFFORDABLE on-the-spot counseling and contact tracing Less than $5 to $10 per test. interviews. THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 26
The development of clear evidence on exist- FDA sensitivity requirements for approved ing tests and tests imminently coming to screening tests, making sure the perfect is not market to enable employers, school leaders, the enemy of the good. policymakers and others to make informed decisions about screening tests in asymptom- For viruses like SARS-CoV-2, speed of report- atic populations, to help contain and avoid ing has proven more significant than very outbreaks. high sensitivity in reducing spread – though both are important.18 For Covid-19, the two We need a paradigm shift that differentiates days before and after symptoms appear are screening testing from diagnostic test- the days of peak infectivity. Individuals often ing. Screening testing of large swaths of the do not self-quarantine unless symptoms asymptomatic population should be viewed become severe. The three to five-day turn- with a pandemic-control lens, rather than a arounds often experienced with rtPCR testing clinical healthcare lens. Clinical diagnostic means that results arrive after most of the testing is focused on the appropriate diagnosis infectivity period has passed. and treatment for a specific presenting indi- vidual. Today, the best of these tests are highly Point of care (POC) or point of services (POS) accurate rtPCR based with sensitivity of more tests suitable for large-scale screening are than 98%. They are performed mostly in a lab- beginning to come onto the market. New tests oratory setting and may take two days or more and collection methods often meet initial for results. Symptomatic patients are expected skepticism, as did saliva testing. Saliva was an to isolate pending test results so that delay in unconventional but desirable alternate to the test results does not lead to more infections. dreaded nasopharyngeal swab. Initially con- sidered unreliable, the saliva test is showing Key Principles and Considerations for Effective increased reliability and may be superior to Asymptomatic Screening Strategies the nasal swab, especially in the early stages of the disease.19 As more saliva tests are devel- oped and validated, it may be an ideal test for To best reduce transmission, screening test- hospitality and other settings where non-inva- ing must value speed over sensitivity and be sive DIY tests are needed. conducted frequently. Achieving high fre- quency of testing requires a massive increase 18 https://www.medrxiv.org/ in test availability, ease of administration, and content/10.1101/2020.06.22.20136309v2 19 https://www.sciencedirect.com/science/article/pii/ a significant decrease in per test costs. If this S0163445320302139 model holds up, then we need to re-think the THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 27
What got us to Endorsement of asymptomatic screening testing by public health officials, insurers Despite this progress, the U.S. is far from being on track to reach the 30 million-plus 3 million won’t get and healthcare providers, along with more tests it needs by fall. Shortages in test kits, us to 30 million rapid FDA authorization of the needed tests, will be vital to encourage their development, reagents and collective devices continue in many areas. The average cost of a test is too tests per week to secure reimbursement for screening tests, expensive – still around $100 apiece. Results and to protect schools, employers, and other can still take days to come in. The tests remain organizations from potential legal concerns. uncomfortable, and inconvenient. This includes clear regulatory pathways to authorize such screening tests during the pub- Resolving the crisis in lab-based diagnos- lic health emergency, and reliable mechanisms tic testing capacity of manufacturers now for payment for appropriate testing, through appears to outstrip the capacity of labs to employers, health insurers, or government process the tests. The combined capacity of subsidies for priority populations. manufacturers of diagnostic platforms, test kits, and reagents is estimated at well over 50 Testing capacity has more than tripled since million Covid-19 diagnostic tests per week. 20 the nationwide clamor for testing in late April. Based on Department of Health and Human Walk-in, drive-through, and mobile testing services estimates, however, the combined facilities are becoming increasingly common capacity of commercial reference labs, public across the country. Increased federal funding, health labs, hospital and academic labs, and action by many states to increase testing, and point-of-care (e.g., CVS, Walgreens) to process ramped up production by established diag- or administer Covid-19 tests is believed to be nostics manufacturers have all contributed to around 7.5 million tests per week. 21 Pooled or substantial increases in testing. batch testing22 can enable commercial, hospi- tals and university labs to increase their testing 20 Based on HHS May 26th Report to Congress, https:// www.democrats.senate.gov/imo/media/doc/ That’s the good news. Remember when the capacity. But the vast majority of current tests, COVID%20National%20Diagnostics%20Strategy%20 nation doubted whether we could go from one nearly 90%, remain lab-based at a time when 05%2024%202020%20v%20FINAL.pdf (assumes 100% utilization of diagnostic platforms for COVID million a week to two or three times that level? the market is expected to swing heavily toward tests, includes EUA commercially authorized We accomplished that goal, but we now must on-site point-of-care and at-home testing. diagnostic tests only, and publicly available information provided by Deloitte.) turn to the next critical threshold. Test sam- 21 Estimated from HHS May 26th Report to Congress, ple collection has also progressed, with many https://www.democrats.senate.gov/imo/media/doc/ COVID%20National%20Diagnostics%20Strategy%20 tests now collecting samples in easier ways, 05%2024%202020%20v%20FINAL.pdf,CDC, and including saliva-based tests and more easily independent resources provided by Deloitte. 22 http://ctbergstrom.com/publications/ administered nasal swabs. pdfs/2020CHE_full.pdf THE ROCKEFELLER FOUNDATION NATIONAL COVID-19 TESTING & TRACING ACTION PLAN 28
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