Insights Series Issue 20: "COVID-19 testing in the vaccine era"

A thought leadership paper about challenges and solutions for healthcare executives.

Insights Series Issue 20 expanding-precision-medicine The New Normal CORONAVIRUS COVID-19 O COVID-19 testing in the vaccine era Challenges and solutions for healthcare executives A thought leadership paper on how to ‘Expand precision medicine’ SIEMENS Healthineers Preface The Insights Series The Siemens Healthineers Insights Series is our preeminent thought leadership platform, drawing on the knowledge and experience of some of the world’s most respected healthcare leaders and innovators. The Series explores emerging issues and provides you with practical solutions to today’s most pressing healthcare challenges. We believe that increasing value in healthcare – delivering better outcomes at lower cost – rests on four strategies. These four principles serve as the cornerstones of the Insights Series. Expanding Transforming Improving Digitalizing precision care patient healthcare medicine delivery experience The New Normal The New Normal is a special edition of our Insights Series focusing on the COVID-19 pandemic. This series provides recommendations on how to confront the current SARS-CoV-2 outbreak and its implications, as well as strategies and ideas on how to emerge from the current crisis stronger, more resilient, and better prepared to address the healthcare challenges that lie ahead. Please visit Executive Summary COVID-19 testing will continue to have a substantial Solutions to these challenges include: appropriately impact on every aspect of hospital operations using COVID-19 tests; establishing appropriate clinical throughout the current vaccination era and into and non-clinical processes to meet testing demand; the foreseeable future. Quality of care, financial refining testing protocols that address infection performance, personnel, organizational reputation prevalence based on clinical and social determinants; and the management of patients with other and planning for rapid responses to significant changes conditions can all be improved through effective in the pandemic. management of COVID-19. Healthcare executives play a central role in developing and sustaining We recommend that healthcare executives take these awareness, and providing support to their teams four key action steps to prepare their institutions for in the critical area of COVID-19 testing. effective long-term management of the COVID-19 pandemic: Testing continues to be a cornerstone in the fight against the pandemic on both an individual and societal level. 1. Emphasize the continuous relevance of a sound The advent of vaccines and effective treatments offers and effective COVID-19 testing strategy new scenarios for management and requires refined 2. Foster care team coordination to support appropriate thinking around testing to derive the most strategic testing infrastructure value from it. 3. Develop customized testing protocols to address Four key testing challenges for executives in the the specific needs of each relevant subpopulation vaccination era are described here: (e.g. immunosuppressed or immunocompromised, with pre-existing conditions) 1. Identifying infected patients accurately and quickly, for appropriate isolation and control measures 4. Prepare organizations to be vigilant about considering the unknowns, including the relevance of virus 2. Infrastructure, access, and logistics complexities variants and immunity assessment associated with testing 3. Tailoring testing protocols appropriate for different By taking these steps, healthcare executives will enable subpopulations of patients their organizations – and the communities they serve – 4. The inevitable unknowns: virus mutants, the efficacy, to better meet the evolving demands of the pandemic duration and persistence of vaccines, and the role of with precise, adaptable, and scalable testing strategies. immunity passports Siemens Healthineers Insights Series · Issue 20 3 The challenges The COVID-19 pandemic continues to place unpre- The critical role of healthcare executives in COVID-19 cedented strains on hospitals and other care settings. testing is sometimes overlooked because of the emphasis Some of these challenges are nearly universal, like on technical perspectives, but healthcare executives play higher pressure on costs, increased stress on a decisive role in creating and executing a successful personnel and patients, and the impact on care for organizational approach to testing. other medical conditions. Some institutions must also cope with unit-specific challenges, including Administering COVID-19 tests may introduce new allocation of sufficient ICU beds and staff to deal complexities. There is a need for precision in COVID-19 with sudden spikes in COVID-19 cases.1 testing technology, but implementation of testing programs goes far beyond the science and technology of One thing has remained clear over the course of the the tests and analyzers used. In fact, COVID-19 testing pandemic: a robust testing program is one of the requires alignment of virtually every facet of a healthcare cornerstones of an effective COVID-19 strategy. Handling organization. Who should be tested, and when? Which the pandemic successfully can have a positive effect tests are appropriate in different scenarios and contexts? across the board on healthcare organizations. It can What about the costs? What are the safety guidelines to enable better outcomes, improve quality, cost of care, protect employees conducting the tests? These questions and hospital finances, and enhance organizational should be answered by the organization based on the reputation. best available data. And, because the COVID-19 pandemic and the SARS-CoV-2 virus itself are both continuously evolving, strategic testing frameworks must be designed to quickly integrate new data and guidelines to continually refine testing programs. The following pages detail some of the key challenges to effective testing programs. 4 Issue 20 · Siemens Healthineers Insights Series 1 Identifying infected patients accurately Unfortunately, there is no one test that fits all needs, and quickly but assays that can help to identify people who are infectious are crucial to keeping hospitals operating Vaccination has the power to transform the COVID-19 in a safe, relatively low-risk environment. pandemic, but the release of effective vaccines does not mark the end of the pandemic, or end the need to Testing programs can reduce the burden of COVID-19 test patients for coronavirus infection. Community on hospitals and healthcare systems, but they require transmission will continue throughout vaccine rollouts, the appropriate use of precision tests. and potentially after, if COVID-19 becomes an endemic or seasonal infection. 2 Infrastructure, access, and logistics complexities COVID-19 testing saves lives, both directly and in- associated with testing directly.2 Identifying patients with active infection enables vigilance and treatment appropriate to the Challenges associated with testing go beyond the tests specific patient. Testing also helps to protect the lives themselves. The best test in the world is only effective if of those who have come in contact with an infected people, especially at-risk populations, have access to it, individual by ascertaining their infection and/or antibody and if they receive their results in a timely manner. response status. And finally, isolation or quarantine of suspected or confirmed cases prevents further Even when people have access to testing, the turnaround community transmission. time between sample collection and receiving results could be reduced by improving capacity to more quickly process tests. Data published in August 2020 by the COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States (The COVID States Project) indicate that at that time, many people in the U.S. faced unacceptably long waiting times for results. Siemens Healthineers Insights Series · Issue 20 5 According to The COVID States Project, while testing 3 Tailored testing protocols required for different turnaround on nasal swab samples has improved in the subpopulations of patients U.S., it still falls short of the preferred mark. In many parts of the U.S.:3 Symptomatic patients should receive prompt testing and • Average wait times for COVID-19 test results was 2.2 results for COVID-19 infection. Asymptomatic patients days in December 2020 (vs 3.9 days in March 2020) with known exposure should also be tested. But what • Racial disparities persist: Hispanic and Black are the parameters around this testing? How should respondents waited 0.7 and 0.4 days longer, community prevalence/test positivity influence testing respectively, than white respondents, as of procedures? December 2020 • A significant lag time – 2.4 days – exists between Who else should be tested, and how? What is the patients seeking a test and obtaining one appropriate screening for plasma donors? How often • Testing remains too slow to support effective should healthcare providers be tested? What about contact tracing immunocompromised people? Additional concerns include availability of lab testing Of particular concern is how to test populations that capacity, reagents, personal protective equipment (PPE), have factors increasing their likelihood of being exposed and personnel. While many of these logistical challenges to COVID-19, and those who are associated with more have been partly overcome since the early days of the severe COVID-19 outcomes (medical conditions like heart pandemic, they still require careful planning and disease, chronic pulmonary disease, and diabetes). monitoring as the COVID-19 pandemic rages on. O 6 Issue 20 · Siemens Healthineers Insights Series In the U.S., communities of Hispanics, African Americans, tests, response to current treatment, and response to and other racial and ethnic minority groups face elevated one or more vaccines. New SARS-CoV-2 variants with risk for COVID-19.4 This elevated risk is attributable, at clinically meaningful characteristics continue to emerge. least in part, to social determinants of health, including limited access to healthcare, occupational exposure to Significant variants that were first detected in the UK infection (many essential workers are people of color), (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) appear and more densely populated housing. to spread more easily from person to person.5 Some data suggest that the P.1 variant may bind more readily An effective testing program should be comprehensive, to cells and may be more likely to evade antibodies equitable, and tailored to the needs of each subpopu- compared to the pre-variant virus.6 It is not yet known lation, because poorly controlled outbreaks in any whether any of these variant strains affects the severity community are a threat to every community. of illness or the likelihood of reinfection, but clearly this evolving situation warrants careful surveillance enabled by effective testing protocols. 4 The inevitable unknowns The emergence of such new variants, while expected, Viral mutations are inevitable, and the impact of those highlights the need for continued assessment of mutations is not foreseeable. Mutations can be irrele- vaccines, continued testing when appropriate, and vant, or they can have clinically relevant effects on monitoring of tests to ensure that they continue to infectivity, disease severity, detectability with current reliably detect the various mutated strains. A key unknown is the long-term efficacy of vaccines, even against the currently identified strains. Testing strategies after vaccination would focus more on emerging relevant topics, like assessing immunity status, the need to accelerate diagnosis to accommodate a return to normal social and commercial activity, identifying non-immune people, identifying new mutations, and evaluating the potential need for revaccination based on clinical or social determinants of risk. And since some patients are not eligible for vaccination and others will refuse vaccination, testing them after possible exposure and/or development of symptoms is vitally important. ! Siemens Healthineers Insights Series · Issue 20 7 Solutions Solution 1: Tests There is no one test that fits all needs, but assays that A PCR test is intended to detect a portion of the genetic can identify people who are infectious are crucial to material of the virus, generally from a sample collected keeping people healthy and opening or keeping the with a nasal or throat swab, and is considered the gold world’s economies open. standard for detecting current infection. These tests are highly accurate but are not without limitations. While it There are three main types of tests available. Two types is considered the gold standard, handling requirements detect viral material to help in the diagnosis: molecular can be stringent and most importantly, the tests may not tests (typically, polymerase chain reaction or PCR) and detect nascent infections in recently exposed people antigen tests. The third type of test detects not the virus, (as available material may not yet be detectable). The but the immune response to the infection (serological or accuracy of PCR tests depends on the appropriate sample antibody testing). These latter tests assess whether the collection process (which can be uncomfortable), as well patient has been infected with the virus, but even as as on the effectiveness of lab personnel in handling the they can be used as an adjunct test on symptomatic late sample and managing technical requirements like cycle presenters when PCR is negative, they are not conclusive threshold (Ct) times. In addition, a positive PCR test for diagnosing ongoing infection. might indicate a recent infection, although the pro- longed detection of viral RNA does not always indicate Executives must be aware that the results of each type the virus is still capable of replicating or being of test provide different information. No single test is transmitted to others. perfect, as each has limitations that need to be con- sidered by clinicians and patients alike to appropriately interpret the results. O PCR Antigen POC Antibodies Molecular and Lab Serology Virus Immune response 8 Issue 20 · Siemens Healthineers Insights Series Antigen tests have emerged as a way to quickly screen The other type of test is the antibody test, which can for individuals who are likely to be currently infectious. indicate recent or prior infection with the virus. Such They detect the presence of specific viral proteins (anti- tests are also useful for tracking community transmission gens), can produce results in minutes after being loaded and estimating total disease burden in a community, as onto an instrument, and are available as both point-of- well as detecting prior COVID-19 infection in an indivi- care and laboratory-based tests. Rapid point-of-care dual person. Results for an antibody test are often avail- antigen tests can be performed by people without able more quickly than for PCR tests, and some tests can extensive clinical qualifications and without the need be run in point-of-care settings. Antibody tests can be for laboratory equipment, which expands access quantitative, meaning they can track persistence of significantly. While the speed with which rapid POC tests immune response over time. See figure 1 for additional can produce results is a strength, these tests may only comparisons of current tests. reliably work in the presence of high viral loads.⁷ Lab-based antigen tests are another tool emerging as Additional tests used in various settings include self- a means to scale testing throughout our communities. tests, home-based tests, saliva tests, and breath tests. With adequate infrastructure and personnel, commu- They are under different phases of development and nities can scale their COVID-19 diagnostic capabilities commercialization in various countries. by thousands of tests per day and provide results within 24 hours and as quickly as 45 minutes. The typical Different test types complement each other; they sample collection is via anterior nasal swabbing, which provide different information at different phases of is more comfortable than nasopharyngeal swabbing. the infection. Siemens Healthineers Insights Series · Issue 20 9 Fig. 1 Complementary roles of PCR and serology With time, viral loads decrease while antibody titers increase. Satellite Testing Large-scale Testing and Diagnosis Management and Monitoring Near-patient testing can be Clinicians use diagnostic tests to determine Management and monitoring are critical in deter- used to identify and isolate if people have current COVID-19 infections, mining the full scope of the disease, combating infected people more quickly. enabling patient management decisions. the pandemic, and rebuilding public confidence. DOXI Point-of-care Rapid High-throughput Lab Molecular PCR testing High-throughput Lab Point-of-care Antigen Testing Antigen Testing Gold standard for Antibody Testing Antibody Rapid antigen testing can Intended for fast, safe accurate and early Highly accurate for detection and Testing help communities to get and accurate, high-scale detection of infection. monitoring of immune response ahead of the spread. community screening. through infection and in vaccination. SARS-CoV-2 exposure Serology test for antibodies Likely negative Likely positive Molecular test Likely negative + Likely positive Likely negative for virus DOI Antigen test Likely negative + Likely positive Likely negative for virus RNA Antigen IgM antibodies IgG antibodies Week -2 Week -1 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Before symptom onset After symptom onset Estimated time intervals and rates of viral detection are based on data from several published reports. Because of variability in values among studies, estimated time intervals should be considered approximations and the probability of detection of SARS-CoV-2 infection is presented qualitatively. 10 Issue 20 · Siemens Healthineers Insights Series The interpretation of a test result depends not only on the test’s accuracy, but also on the likelihood that the person has COVID-19. That likelihood is determined by infection rates in the geographic area and whether the person shows symptoms. If someone from an area with currently high levels of COVID-19 has symptoms typical of the illness but gets a negative result, there is a higher chance it is a false negative, and merits double-checking with PCR testing. The virus can affect not only the lungs but also multiple physiological systems: the heart, the kidneys, the brain, and the blood vessels. Moreover, hemostasis (clotting) can be affected in patients with moderate to severe infection. Other tests might be used to evaluate the severity of the infection as well as the general clinical condition of the patient: coagulation testing, measuring inflammatory markers (like Interleukin-6), imaging (chest x-ray, ultrasound, CT scan), and blood gas testing. These tests can be critical in developing a complete clinical picture and assigning patients to the most appropriate care pathways. A comprehensive testing program takes advantage of each of these modalities in a contextually appropriate way to produce the most complete picture of the individual patient as well as the size and shape of the pandemic. Siemens Healthineers Insights Series · Issue 20 11 Solution 2: Putting the right processes in place Beyond the tests, there’s a testing infrastructure that There are also effective ways to stretch limited ought to be in place at hospitals and other clinical PCR resources: facilities. Personnel (clinicians, nurses, laboratory), testing education (for clinicians and patients), swabs Pooled PCR testing: A potential workaround to limited and other supplies, PPE, transportation, and laboratory capacity for PCR testing is pooling samples from several capacity must all be assembled and regularly maintained different individuals into one sample to determine to serve the needs of a robust testing program. One whether any of them show presence of viral particles. weak link in the chain can severely restrict the capacity Only individual samples from a pool with a positive result of the overall program by compromising timing, quality are run separately. This method is not appropriate when or access. Availability of reagents, sample collection incidence/positivity is high, but it can dramatically tools, analyzers, and personnel can each be a bottleneck increase the speed and reach of screening in lower- in COVID-19 testing. Healthcare executives can help prevalence situations.8 speed the process by creating a plan for rapidly scaling up testing capacity during local or regional outbreaks. Point of care rapid tests: Some countries (India is one example) that don’t currently have the resources for Fortunately, logistics related to testing for COVID-19 have many PCR tests have been using point of care antigen improved dramatically from the frustrating situations tests for many months as a way to supplement their that characterized the early pandemic response in many testing capacity. Other nations that have greater PCR nations. But healthcare executives must not let down test capacity are only just starting to roll out the rapid their guard; there is still room for improvement. alternatives in a limited way, because of their concerns over accuracy. Lab-based antigen tests: By leveraging the existing infrastructure within clinical labs, such as those in hospitals or clinics, communities can rapidly scale up their COVID-19 testing capabilities. One example would be analyzers that can generate hundreds of results per hour. - Less stringent handling requirements: Sample handling and processing errors can decrease the accuracy of reported test results. Tests that require less stringent collection and handling can be of help in stretching testing resources to cover more of the population. OO O 12 Issue 20 · Siemens Healthineers Insights Series Solution 3: Create detailed testing protocols for specific populations The U.S. CDC recommends testing protocols that account It’s critical for care teams to develop and continually for community prevalence and overall test positivity. In monitor and modify testing protocols for specific patient essence, the higher the positivity rate in the community, populations in order to provide timely and accurate the more vigorous the testing efforts should be.9 information about COVID-19 and to enable early interventions for more patients. It is important to emphasize that testing can have the greatest impact in communities that face the greatest burden from COVID-19. It is vital for healthcare executives to support and engage their teams in the creation of clear and culturally appropriate community outreach programs, along with testing protocols and sites, to facilitate testing, delivery of results, and delivery of follow-up care to members of high-risk communities. Fig. 2 Indicator Low Moderate Substantial High Cumulative number of new cases per 100,000 persons <10 10–49 50–99 ≥100 within the last 7 days Percentage of NAAT tests that are postitive during the <5 5%–7.9% 8%–9.9% ≥10.0% last 7 days Recommended action Focus on ensuring Weekly screening Weekly or twice a Twice a week or more testing for all close testing of select groups week screening testing frequent screening contacts of cases and plus testing of close of select groups plus testing of select groups potentially expanding contacts testing of close plus testing of close using a tiered approach contacts contacts to those who might have exposure U.S. CDC testing protocols based on community indicators Siemens Healthineers Insights Series · Issue 20 13 Solution 4: Being vigilant toward the unknowns The tests described earlier in this publication are a pivotal Testing in the post-vaccination era part of the COVID-19 response. The speed with which the scientific and MedTech communities have delivered tests While the number of COVID-19 cases will presumably and vaccines is remarkable. Testing will continue to save decline as more people are vaccinated, the virus remains lives by informing accurate diagnosis, thus enabling both unlikely to be completely eradicated, even if the the prompt treatment of infected patients and the pandemic is largely controlled. The importance of testing mitigation of community spread. will continue to be high because of several factors. Some people will decide not to be vaccinated (vaccines in the The pandemic has persisted for so long that many vast majority of countries are non-mandatory), some people may think it is over, or they may feel like giving people might not have access to vaccines for some time, up on the mitigation efforts that have disrupted so many the vaccines themselves will not always be effective lives. But COVID-19 continues to evolve, posing new (efficacy varies by vaccine and mutation), new viral challenges to healthcare systems. Healthcare executives variants may be resistant to current vaccines, and we should maintain a state of vigilance and readiness in don’t know how long vaccine-conferred immunity might their teams, so that their organizations can respond last. Increased air travel between countries also rapidly and effectively to emerging changes in the introduces additional risk of spreading the virus and pandemic and in the SARS-CoV-2 virus itself. mutations, depending on disparities in virus control among different regions. The following developing topics related to testing are not meant as guidelines, but to help as potential approaches to emergent challenges. Using testing to assess immunity At this point in the pandemic, while vaccine companies are using neutralizing antibodies (the ones related more directly to the infection, especially the virus “spike”- associated proteins) to define clinical trial population seroconversion, there is no definitive threshold for anti- body-mediated immunity. Ongoing research is likely to elucidate important correlations between antibody titers and immunity after infection or vaccination among diffe- rent subgroups of patients and at the individual level. Although more work needs to be done to validate tests for these purposes, measuring SARS-CoV-2 IgG antibodies in relation to vaccination may be beneficial and even necessary for (1) establishing a threshold for protection or likely immunity, (2) confirming an initial neutralizing antibody response shortly after vaccination (approximately 3–4 weeks after each dose), and (3) 14 Issue 20 · Siemens Healthineers Insights Series The European Union’s Joint Research Centre and the U.S. Centers for Disease Control and Prevention are assessing data to evaluate whether concentrations of specific antibodies in the bloodstream can help in establishing a clinical threshold for tests that could identify whether a person is likely immune. Vaccination Months after vaccination 3–4 weeks after vaccination1 3, 6, 9 months after vaccination Annually after vaccination • Confirms initial neutralizing • Confirms persistence and • Assesses persistence and antibody response duration of immunity duration of immunity • Helps ensure antibody • Provides the means to sero-bridge • Informs requirements for response clears threshold abridged trials to additional future vaccinations for immunity populations 1 For a 2-dose regimen, the proposed timing is after each dose. tracking of antibody levels (at approximately 3, 6, and Testing and immunity passports 9 months and annually) following vaccination. Testing already has been used by different countries The above schematic describes potential uses of anti- as a passport for international travel, particularly a body testing following vaccination. Implementation negative PCR test (and/or antigen test when traveling of this pathway into clinical practice will require the to the U.S., for example). Evidence of past infection establishment of a recognized threshold of immunity and/or vaccination has been discussed for possible and the validation of antibody tests for these purposes. implementation in various ways by different countries, both in the public and private sectors (back to work, Other uses for antibody tests have emerged, including back to school, boarding an airplane, etc.), and to the use of antibody titers to identify ideal convalescent enable resumption of social, educational, professional plasma donors for the treatment of patients with severe and travel activities. This may offer opportunities for disease. keeping economies open as safely as practical, but it may also raise ethical concerns about privacy and Vaccine efficacy studies together with serological discrimination, among others. The use of Hepatitis and surveys are potentially important tools for providing MMRV serology can offer lessons that may be applicable data to guide large-scale strategic decisions on in this instance.10 managing the pandemic. Siemens Healthineers Insights Series · Issue 20 15 Immunity passports, when implemented via targeted Vaccination of previously infected patients and ethical approaches in conjunction with proper testing and vaccine solutions, have the potential According to the CDC in the U.S., vaccination should to become optional tools to control the spread of be offered to persons regardless of history of prior COVID-19. symptomatic or asymptomatic SARS-CoV-2 infection. At the same time, in a world of scarce vaccine supply, On March 17, 2021, the European Commission pre- antibody testing has been used in the clinical trials of sented a proposal to create a Digital Green Certificate pharmaceutical companies as one way to assess vaccine to facilitate the safe free movement of citizens within efficacy. And, as is happening in Europe, antibody testing the EU during the COVID-19 pandemic. Digital Green is being used to prioritize recipients. A good example is Certificates will be valid in all EU Member States. Lithuania, which considers testing in prioritizing the A Digital Green Certificate is digital proof that a vaccine. person has either been vaccinated against COVID-19, received a negative test result or recovered from COVID-19. The Digital Green Certificate should Testing and virus mutations and variants facilitate free movement inside the EU. It will not be a pre-condition to free movement. There are approximately 8,000 SARS-CoV-2 mutations that have already been identified though genomic In a similar approach, on March 29, 2021, New York sequencing. The emergence of more serious variants began offering a digital pass (Excelsior Pass) app that raises concerns about their resistance to antibodies people can download to show proof of vaccination or elicited from previous infection or vaccination. As the a negative COVID-19 test. The “Excelsior Pass” will be chances of new variants reducing the sensitivity of tests accepted at major entertainment venues, as part of exist, ongoing surveillance is vital to public health as enabling more sectors of the economy to reopen they may present new challenges to diagnosis and more safely. treatment. PCR tests targeting more than one area on highly conserved regions of viral RNA may be useful in monitoring emergence of new viral variants. Properly validated testing protocols, including genomic sequencing, should be able to help in the identification of infection with new mutants and potentially vaccine- resistant strains, should they emerge. Precise testing, applied appropriately, is the key to managing these unknowns. Healthcare leaders should formulate strategies to deal with these possibilities now, to enable an effective response in the eventuality that emerging issues complicate management of the pandemic. 16 Issue 20 · Siemens Healthineers Insights Series Conclusion Suggested follow-up on expanding-precision-medicine • Testing remains a cornerstone of COVID-19 Precision diagnosis in the COVID-19 era and beyond. Available at: management. As the pandemic further evolves, news/precision-diagnostics so too must testing strategies. Continued refinement of COVID-19 tests, along with the infrastructure to • Moving toward precision in managing pandemics – support widespread testing, is vital to obtaining Five critical domains for success in public health. precise information on individual patients and Available at: news/moving-toward-precision-in-managing- about the status of the pandemic at large. pandemics.html The authors see four key actions for healthcare • SARS-CoV-2 Serology Testing in the Setting executives as they guide their institutions through of Vaccination. the COVID-19 pandemic: Available at: laboratory-diagnostics/assays-by-diseases- 1. Healthcare executives should continue highlighting conditions/infectious-disease-assays/vaccine- the relevance of testing in the vaccination era, position because the virus has the potential to affect virtually every clinical and operational aspect of hospitals and other care settings. i Information 2. Executives should foster care team coordination to The Siemens Healthineers Insights Series is our support testing infrastructure. Processes include preeminent thought leadership platform, drawing on the knowledge and experience of some of the world’s most identifying the right tests, providing ongoing respected healthcare leaders and innovators. It explores education to staff and patients, refining and emerging issues and provides practical solutions to reinforcing testing logistics, and making plans to today’s most pressing healthcare challenges. scale up testing and patient management as the situation merits. All issues of the Insights Series can be found here: 3. Healthcare executives should lead the effort to develop and implement specific protocols for different subpopulations based on clinical and social factors. Contact 4. Healthcare leaders should maintain vigilance and For further information on this topic, or to contact the build responsive teams in their organizations to authors directly: prepare for the unknown, from clinically significant novel virus strains to unexpected data on vaccine Reto Merges efficacy. Global Head of Expanding Precision Medicine The common thread throughout these actions is the [email protected] importance of precision testing for COVID-19. The arrival of vaccines does not signal the end of the battle, but rather a shift in tactics. Healthcare leaders who antici- pate and prepare for changes in COVID-19 testing will perform a great service to the communities they serve. Siemens Healthineers Insights Series · Issue 20 17 References 1. Begun JW, Jiang HJ. Health Care Management During COVID-19: Insights from Complexity Science. NEJM Catalyst. October 9, 2020. 2. NIH National Institute on Aging. Why COVID-19 testing is the key to getting back to normal. September 4, 2020. 3. The COVID States Project. Report #33: update on covid-19 test turnaround times across the country. January 2021. 4. U.S. Centers for Disease Control and Prevention. Health Equity Considera- tions and Racial and Ethnic Minority Groups. Updated February 12, 2021. 5. U.S. Centers for Disease Control and Prevention. New Variants of the Virus that Causes COVID-19. Updated February 2, 2021. 6. Young LS. Expert comment – new Brazilian variant of COVID-19. Warwick Medical School News and Events. January 15, 2021. 7. Guglielmi G. Rapid coronavirus tests: a guide for the perplexed. Nature news feature. February 9, 2021. 8. U.S. Centers for Disease Control and Prevention. Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing. Updated October 23, 2020 9. U.S. Centers for Disease Control and Prevention. Overview of Testing for SARS-CoV-2 (COVID-19). Updated March 17, 2021. 10. Brown RCH, Kelly D et al. The Scientific and Ethical Feasibility of Immunity Passports. Lancet Infect Dis. 2021; 21: e58–63. 11. Digital Green Certificate. Accessed April 16, 2021:. work-travel-eu/coronavirus-response/ safe-covid-19-vaccines-europeans/covid- 19-digital-green-certificates_en. 18 Issue 20 · Siemens Healthineers Insights Series About the authors Luis M. Lasalvia, MD Reto Merges Vice President and Global Medical Officer Global Head Expanding Precision Medicine Siemens Healthineers New York, US Siemens Healthineers Dr. Luis Lasalvia, Vice President and Global Medical With more than 10 years’ leadership experience in Officer, drives for more effective and patient centric healthcare marketing, Reto Merges has a strong track healthcare in actual practice, by integrating medicine, record in building effective teams for clinical and technology, and finance. His clinical expertise is coupled innovation marketing. In addition, he has four years with extensive team leader experience in the pharma- of work experience in China, ramping up efforts for ceutical and medical device industries. He has covered research collaborations in China and South Korea. multiple roles as strategist, practicing physician, deal maker and negotiator, and technology scouter. He holds a degree in electrical engineering and information technology from the Karlsruhe Institute of Entrepreneur and innovator with international Technology, Germany, and has studied at the Nanjing background, Luis has participated in projects in more Normal University, China. His scientific background is in than 50 countries in all continents, innovating, and the field of medical imaging, where he has authored creating novel and action-oriented insights, by many publications and holds multiple patents. proactively collaborating, and working together with organizations and top leaders around the globe. Dr. Luis Lasalvia has been guest speaker, panelist and moderator at approx. 500 conferences and events around the world, submitted several patents in the US and Europe, and authored more than 50 papers and articles in peer review journals and other prestigious publications. Medical Doctor (Republic University, Montevideo), Master International Business (Pompeu Fabra University, Barcelona), and Postgraduate degrees in Business Administration and in Marketing. Completed Entre- preneurship, risk management, and innovation executive studies at The Wharton School of Business, New York University, and Harvard Business School. 20 Issue 20 · Siemens Healthineers Insights Series At Siemens Healthineers, our purpose is to enable healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare. An estimated five million patients worldwide benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine as well as digital health and enterprise services. We are a leading medical technology company with over 120 years of experience and 18,500 patents globally. With about 50,000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare. Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 Published by Siemens Healthcare GmbH · 0521 · HOOD05162003185304 ©Siemens Healthcare GmbH, 2021

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