Infectious Disease Specialists Share their Perspectives on Some Major COVID-19 Testing Issues

April 18, 2020
At a Friday press briefing sponsored by the Infectious Diseases Society of America, two infectious diseases specialists commented on the extreme complexity of the nationwide situation around COVID-19 testing

In a web- and telephonically based press briefing on Friday, April 17, leaders in the Arlington, Va.-based Infectious Diseases Society of America (IDSA), which represents infectious disease physicians, epidemiologists, and other healthcare professionals working in the infectious-diseases area, experts shared their perspectives on the subject, “What Indicators Are Needed to Reopen America?”

Indeed, Thursday evening, the Arlington, Va.-based IDSA and its partner organization, the Arlington, Va.-based HIV Medicine Association (HIVMA), released their recommendations on potential steps towards the reopening of business and social activity in the United States in the midst of the COVID-19 pandemic. As the organizations wrote on IDSA’s website, “Everyone in the U.S. is eager to return to their way of life before the onset of the COVID-19 pandemic. Easing social distancing restrictions prematurely or without careful forethought and planning will negate the progress we are starting to see and cause unnecessary mortality. Decisions to ease COVID-19 distancing restrictions must be based on the best available scientific data. Easing restrictions too quickly can increase spread of infection and mortality, overwhelm health care facilities, and prolong economic suffering. This document focuses on the health care system and public health issues that must be addressed before any social distancing policies can be eased.”

Further, the societies stated, “There are additional important elements to be considered including guidance on resuming activities safely for educational systems and the business sector. IDSA and HIVMA have developed recommendations for incremental steps to easing physical distancing measures based on testing, public health and workforce capacity. This workforce will encompass not only those at traditional points of health care delivery, including hospitals and clinics, but also critical partners in public and community and rural health who will be essential to executing this plan on the ground. We emphasize that leadership from the Centers for Disease Control and Prevention will be critical for building the capacities necessary to safely and incrementally re-open the country, orchestrating the implementation of these plans and monitoring the need to adjust our strategy in response to disease activity. Our recommendations will be updated as additional information becomes available.”

IDSA and HIVMA wrote that “Easing strict social distancing rules should be done on a systematic, progressive basis. Changes should be guided by regional and community data from across the U.S. and must take into consideration local and regional preparedness levels as well as strong public messaging for maintaining individual personal hygiene and social distancing practices. Available published studies indicate that physical distancing combined with good hand and environmental hygiene can reduce transmission of respiratory viruses in both the workplace and home. A stepwise approach to reopening should reflect early diagnosis and enhanced surveillance for COVID-19 cases, linkage of cases to appropriate levels of care, isolation and/or quarantine, contact tracing, and data processing capabilities for state and local public health departments. The phases of this approach are outlined below.”

Among the societies’ recommendations: “widespread, sustained availability of accurate diagnostic testing, including validated nucleic acid amplification assays (NAAT) and anti-SARS-CoV-2 antibody detection with known performance” characteristics, to allow for “comprehensive case surveillance”;  the phasing in of the reopening of states and regions “based on the ability to safely, successfully and rapidly diagnose, treat and isolate individuals with COVID-19 and individuals who have been in contact with them”; the scaling up of adequate supplies of personal protective equipment and of critical care resources, including of ventilators, ECMO, and dialysis machines; “some degree of physical distancing measures that must “remain in place in prevent recurrent outbreaks”; support for telehealth-based care delivery whenever possible; and broad, longer-term pandemic preparedness, “with investment into R&D, infrastructure (including stockpiles of personal protective equipment and adequate manufacturing capabilities), workforce, and clear governance structures.”

Responding to the policy context of the moment

As the New York Times reported on Friday morning, “The governors of several states have begun to announce plans to ease restrictions in their states, even as cases continue to surge in some parts of the country and inadequate testing will make it difficult for them to identify and contain future outbreaks. They are taking action as President Trump, who has been impatient to restart the economy, issued a set of guidelines Thursday offering suggestions of when and how to reopen.”

The Times staff report noted that “The governors are grappling with mounting economic damage and hardship caused by the pandemic. But their moves to tentatively let some businesses reopen is getting underway as the national death toll remains high. Public health experts are warning against acting too soon, fearing new waves of outbreaks that will be difficult to identify early on unless testing is significantly ramped up. But many states and localities are beginning to ease restrictions.”

Against that backdrop, Thomas File, J.D., M.D., FIDSA, co-director of the Summa Health Antimicrobial Stewardship Program, a professional of medicine and master teacher and chair of the Northeast Ohio Medical University Infectious Diseases Section in the Cleveland suburb of Rootstown, Ohio, and chair of IDSA’s board of directors, led a discussion with Tina Q. Tan, M.D., FIDSA, a professors of pediatrics at the Northwestern University Feinberg School of Medicine in Chicago, and John B. Lynch, III, M.D., M.P.H., an associate medical director at Harborview Medical Center and an associate professor at the University of Washington’s Department of Medicine in the Division of Allergy & Infectious Diseases. Drs. Tan and Lynch are both members of IDSA’s board of directors.

“I live in Seattle and have been working on the coronavirus response for well over two months,” Dr. Lynch began. “Being the first place in the country allowed us to prepare” in a number of ways for the pandemic, he said. “We were able to start building capacity. And as we work through this pandemic… we continue to see outbreaks in some of our most vulnerable populations and communities, and big gaps in testing.” Further, he said, “Here in Washington, we’ve had outstanding government leadership: Governor [Jay] Inslee and Mayor Jenny Durkin have shown leadership around social distancing.” Still, he said, “Even now, almost two months into this work, we have yet to see a drop-off” in cases. “We have some of the best public health agencies in the country, but they were quickly overwhelmed, and that was as a result of years and years of underfunding” of public health nationwide.

As for reopening, Lynch said, “Contact tracing will be a crucial part of this. The social distancing that has been working in some places, as we begin to reopen, will no longer be as effective. So we need widespread testing and contact tracing in order to replace that.”

“The decision to reopen really has to be based on the best scientific data we have; we don’t know the true number of people who are infected and have been infected by COVID-19,” Dr. Tan said. “If we lift social distancing too quickly, this can be really disastrous… and lead to further economic impact. If you look at the document that IDSA and HIVMA just released, it really is a series of evidence-based indicators that need to be in place: broad, widespread, readily available, accessible, accurate diagnostic testing. This has been a major issue here in Chicago and around the country, where we haven’t been able to get testing for people with COVID-19 symptoms. And as the weather gets better, this reduces the social distancing that has been in place. And we need to be able to diagnose and isolate those with COVID-19 and track their contacts.”

What’s more, Tan said, “We’ve seen among African-Americans disproportionate rates of disease, hospitalization, ICU admission, and death. And we need adequate PPE [personal protective equipment], ICU beds, and ventilators. And that will be needed for any future outbreaks. We need to enhance our preparedness for these types of pandemics. It’s going to be crucial to rebuild the U.S. pandemic preparedness with massive investment in equipment, including stockpiling of PPE, and adequate manufacturing capacity so that if we need to manufacture PPE and ventilators, there’s adequate capacity to do so. Future biothreats… will happen. We also need to be involved in a national public and private multi-agency taskforce to be prepared for future pandemics. Basically,” she added, “all these different steps will need to be in place before certain parts of the country can be reopened. And the PPE availability and surge capacity will differ regionally. In order to reopen the country, we really need to ensure that all these steps are in place.”

What might happen after reopening?

In response to a member of the press about how long and how broadly various forms of social distancing might need to be kept in place even after some businesses and activities are reopened, Lynch said, “We continue to have a large number of people who remain in the hospital. It’s important to remember that when people are admitted, they end up in the ICUs for a long time. And that number remains stable for a couple of weeks; we have not seen a drop in that rate. We have seen a decrease in positive cases. We have to [achieve] widespread access to diagnostic testing, as well as to contact tracing,” in order to ensure that hospitals are able to manage levels of need for patient care.

“The social distancing is completely dependent on widespread, easy access to all those tools, so that if you have symptoms, you can be diagnosed and they can do contact tracing,” Lynch said. “At the same time, I see social distancing continuing into the future. I truly do not know what proportion of people in my community have COVID-19. When we look at the proposed dates, my understanding talking to our governor and mayor is that they’re proposed dates, and they really will be depending on public health leaders” to guide them.

What’s more, Lynch continued, “Will everyone be back at work normally? Highly unlikely. We’ll probably need to address current inequities, including” determining which individuals work for genuinely critical industries that must remain active. “And as we back off on social distancing, it will have to be a phased approach. Also, we have to recognize that this virus is not going anywhere. There’s a distinct risk that we’ll just bump right back up” in terms of infection levels. And so we need the hospital capacity and adequate PPE. We need to move out of the contingency part of this, and in some areas of the country, the crisis part. And,” he added, “as we see a new uptick, we may need to have to go back to some increased levels of social distancing.”

In response to the question from another member of the press, who asked about what level of nationwide testing will be needed, and whether Americans will need to be tested repeatedly, Tan said, “I think right now what we really want to do is have broad access to testing, at least to those individuals showing signs and symptoms of COVID-19. We just have not been able to get enough testing done. We also have not had the capacity to trace contacts of those individuals and get them tested. So we need to expand testing so that at the very least, those with symptoms of COVID-19 can be tested, and their contacts. Whether or not we do multiple testing at multiple times, may need to be considered, but right now, we need to test those who are symptomatic.”

“I agree with Tina’s comments entirely,” Lynch said. “Based on our experience here in Seattle, we need access to testing for people with even minimal symptoms. Many colleagues around the country are still needing to be limiting testing to people with severe symptoms. We also need broad, easy, very aggressive testing of people in long-term care facilities; we need to be testing both staff members and residents, regularly. We need to be thinking about at-risk populations. As Dr. Tan mentioned, the African-American community is particularly at risk. Also, people whose first language isn’t English. And people who are homeless or lacking shelter. My concern is over the complex nature of how testing is done in the American healthcare system; we need to make testing accessible in a public health approach—where it’s easily accessible, not dependent on health insurance status. We want to get to where there are no people infected in long-term care facilities.”

“Other populations that really need to be tested now,” Tan said, “are those individuals in prison settings, as well as front-line workers, including transportation workers, firefighters, police officers. We’re really starting to see an increase here in Chicago in infection among those groups. So, broad-scale testing that’s easily accessible, really needs to be done.”

Another member of the press asked the physicians their thoughts on the idea of reopening parts of the U.S. economy and society while protecting vulnerable populations—for example, reopening schools, while protecting the elderly. “There is something to be said for that,” Tan said. “However, you do have other individuals in the household who might potentially be going out and bringing infection back to that setting. So we know that social distancing will be going on for some time, and we want to make sure our most vulnerable individuals will be protected. We need to make sure that if individuals who live with those most vulnerable individuals don’t go out and become infected and bring it back to them.”

Asked about the fact that we do not know the actual prevalence of the virus, Lynch said, “You’re absolutely right; we do not know what the prevalence is. And all kinds of things fall out from that. We actually don’t know how deadly this virus is. And our laboratory testing remains embedded in a clinical environment in our healthcare system, meaning that it’s not fully accessible to the public. People need to be able to get tested very quickly and easily. We need to get the data on individuals, and do contact tracing, call those people, and offer them testing. Once those two aspects are in place, access to testing, and contact tracing, we’ll get a much better picture of what the diffusion characteristics are. And there will be regional differences. What proportion of asymptomatic people are out in the community? We’re seeing enormously divergent estimates (of what that number might be). And until we have easily accessed, publicly supported testing, we won’t know that.”

“That broad access to testing will be really important in determining the true prevalence of this disease,” Tan emphasized. “Because we don’t know that, there’s no way to appropriately open up parts of the country. And until we know that, there’s really no way to safely reopen portions of the country.

What will the role be of serologic testing? “The major role of serologic testing would be to let you know who has been infected; it can also tell you who has not been infected,” Tan said. “But it can tell you who has been infected and whether they’re immune. The problem is, you could know that some has been infected, but we don’t know the length or degree of immunity.”

“There are also a lot of different antibody tests out there with a wide variety of laboratory characteristics,” Lynch noted. “We don’t know how effective each one is. And if we go out and test every other student here at the University of Washington, that would give us a broad population perspective. But right now, testing is embedded inside patient care organizations. And people are looking at this as a tool to say, hey, you can go back to work; or as a healthcare worker, you’re safe. Is there a certain level of antibody that makes you safe? We don’t know how long it will last. And a lot of these tests lack rigor, and have a lot of false positives, indicating a false idea of immune response. We might actually be using these tests incorrectly if we use them as they’re designed now, to let people go back to work. Also, if we can get a good antibody test, it will help us to get a good PCR test. There’s a lot of potential, but a lot of questions remain unanswered.”

“Also, logistically, doing a serologic test will be more complicated than doing the current PCR test, because you need a blood sample,” Tan noted. “We also don’t know, as John said, which of these tests are most reliable.”

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