Antibody Testing Is Important in COVID-19 Response, But More Data Is Needed to Expand Its Role

APHL and CSTE logos

FOR IMMEDIATE RELEASE

Silver Spring, MD, May 7, 2020 — With increasing interest in expanded serological testing as part of the nation’s COVID-19 testing strategy, the Association of Public Health Laboratories (APHL) and the Council of State and Territorial Epidemiologists (CSTE) today issued a joint statement outlining potential public health applications for antibody testing, while identifying caveats that limit its current use.

According to “Public Health Considerations: Serologic Testing for COVID-19,” serologic testing is helpful in estimating the prevalence of past viral infection or the cumulative incidence of infection in the US population. It can also improve understanding of disease transmission patterns and the proportion of people previously infected, among various populations. In order for these methods to be used effectively, however, public health researchers and scientists need more data on the performance characteristics of these tests and the human immune response to COVID-19, such as the persistence and protection offered by antibodies.

“Serological testing is an important part of a testing strategy in response to COVID-19, but there is simply a lot that we still don’t know,” said Scott Becker, MS, chief executive officer of APHL. “Until we have more evidence, serological tests alone should not be used to make decisions such as when staff can return to work, the need for personal protective equipment or the need to discontinue social distancing measures.”

“We don’t have all the information we need yet about COVID-19 serologic testing,” added Janet Hamilton, MPH, executive director of CSTE. “As we learn more, the information will improve our understanding of disease transmission patterns, and data from serologic surveys can be used to understand the proportion of persons previously infected among various populations.”

With the limitations in mind, the statement identifies several potential public health applications, including:

  • Determining how widespread COVID-19 infection has been in a community or population to both understand the scale of the current pandemic and in preparation for future vaccine development and deployment;
  • Identifying people with an antibody response to serve as convalescent plasma donors; and
  • Determining if a person had an immune response to SARS-CoV-2, irrespective of whether they had symptoms or not, yet more data is needed.

The statement also provides an overview of serologic methods, considerations for selecting assays for seroprevalence surveys and for test result interpretation, and outstanding research needs.

For more, contact Michelle Forman at 240-485-2793 or michelle.forman@aphl.org

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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the U.S. and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at www.aphl.org.

Founded in 1951, the Council of State and Territorial Epidemiologists (CSTE) represents the interests of State Epidemiologists from all 50 U.S. states and territories, comprising the Council. CSTE is also the professional home to nearly 2000 practicing applied epidemiologists working at the state, local, tribal and territorial levels. For more information, visit www.cste.org.

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APHL Applauds Revised FDA Policy on Serology Tests for COVID-19

Laboratory scientist performing serologic testing

FOR IMMEDIATE RELEASE

Statement by Scott Becker, CEO, Association of Public Health Laboratories

Silver Spring, MD, May 4, 2020 — “The Food and Drug Administration made the right decision by walking back its policy on serology testing for COVID-19.

“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster. This revised policy makes a lot of sense and should have been in place over the last six weeks.

“The changes announced today bring quality and transparency back into the picture on serology. In addition, it provides important guidance on performance criteria.

“We look forward continuing to work with our partners at FDA in responding to this ongoing pandemic and protecting the health of all of our communities.”

Contact: Michelle Forman, 240-485-2793 or michelle.forman@aphl.org

 

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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the U.S. and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at www.aphl.org.

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Variability in states’ testing numbers: It’s not that simple

Map of the United States

By Gynene Sullivan, manager, communications, APHL

Throughout the COVID-19 response, there has been a lot of discussion about the fact that laboratory testing numbers across the United States have been varied, and this is nowhere more evident than our public health laboratories. But this concept is more than numbers; it resides in a variety of factors.

Being Able to Prioritize
It is incorrect to assume that some states are doing things right, and other states are not performing tests or testing incorrectly. If a state has fewer issues with backlogs, they may have been more successful in prioritizing surge testing, or have been recognized as a hotspot, which leads them to be prioritized for receipt of supplies. This leads to other states not receiving supplies or equipment and, therefore, when surge testing is needed they are less able to respond. If a public health laboratory is able to perform verified testing on equipment that is usually reserved for other testing, they get the advantage of having a backup system in case they run out of supplies for the main testing protocol.

Not All Tests Are Created Equal
There are many different tests that are performed in order to get results during an epidemic. Public health laboratories have a standard operating procedure for each test that is unique to their laboratory, based on their equipment, staff training and certifications. They also follow a meticulous series of protocols to ensure that tests are performed safely and correctly, and that they are not reporting false positives or false negatives. In a situation like this, public health laboratories are using all the tools available in their testing arsenal, while maintaining rigorous scientific processes to get the right results.

Allocation of Needed Resources
There are currently public health system-wide issues that point to supply shortages, equipment shortages and shortages of qualified staff. These tests are deemed to be highly complex that require scientific staff who have been trained to process and analyze them, require specific equipment to perform the testing and require specific materials to ensure the integrity of samples. Even though a state may be able to perform testing 24/7, they would have to suspend any testing if they run out of supplies such as test kits and reagents. And this would result in a cascade effect of non-testing and non-reporting.

Laboratory Capacity
The reality is different states have different capacity to stand up surge testing in a public health emergency. While public health laboratories have preparedness plans to respond to just about anything, no laboratory can be entirely prepared for a global pandemic. If states have the ability to convert to 24/7 surge testing, other requests such as newborn screening, food testing, water testing or STD testing may be deprioritized.

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Nation’s Public Health Leaders Urge President Trump to use All Available Authorities to Quickly Produce Testing Supplies and Personal Protective Equipment

Lab scientist wearing personal protective equipment (PPE)

A joint statement by the Association of State and Territorial Health Officials, Association of Public Health Laboratories, National Association of County and City Health Officials, and the National Emergency Management Association

“We urge President Trump and the Administration to utilize all existing authorities to require American corporations to expand or retool their production lines to urgently produce testing supplies and personal protective equipment (PPE). In order to respond to this pandemic, we need these items in mass quantities right now. Without a forceful and urgent call to these private sector partners, our nation won’t be equipped to contain COVID-19 and we will falter in our collective efforts to suppress this virus and reopen our cities, states, and territories.

“Specifically, production should include rapid manufacturing and production of supplies and equipment necessary for rapid point-of-care COVID-19 testing including reagents, point-of-care kits, viral transport media, laboratory supplies, and related products. Our nation’s recovery depends on public and private laboratories and public health, healthcare, and hospital systems having the capacity to test for COVID-19 in every community throughout the country. After robust testing capabilities are available, we will better be able to determine where and when it is safe to gradually loosen stay-at-home orders and restrictions on gatherings.

“Additionally, rapid manufacturing and production of PPE is needed to exponentially expand in settings where infection and transmission may be highest including hospitals, nursing homes, skilled nursing facilities, correctional facilities, grocery stores, and other venues where people congregate. Expanding PPE access to every necessary setting will protect those who are responding to COVID-19 today, but expansion will also be critical for preventing future COVID-19 transmission and lowering community transmission rates.

Our nation’s recovery from COVID-19 will be based on the rapid production of testing supplies and PPE. Now is the time for every company that can to produce these vital materials to help save American lives.”

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Nation’s Public Health Leaders Urge President Trump to use All Available Authorities to Quickly Produce Testing Supplies and Personal Protective Equipment

Laboratory scientist wearing personal protective equipment (PPE)

A joint statement by the Association of State and Territorial Health Officials, Association of Public Health Laboratories, National Association of County and City Health Officials, and the National Emergency Management Association

“We urge President Trump and the Administration to utilize all existing authorities to require American corporations to expand or retool their production lines to urgently produce testing supplies and personal protective equipment (PPE). In order to respond to this pandemic, we need these items in mass quantities right now. Without a forceful and urgent call to these private sector partners, our nation won’t be equipped to contain COVID-19 and we will falter in our collective efforts to suppress this virus and reopen our cities, states, and territories.

“Specifically, production should include rapid manufacturing and production of supplies and equipment necessary for rapid point-of-care COVID-19 testing including reagents, point-of-care kits, viral transport media, laboratory supplies, and related products. Our nation’s recovery depends on public and private laboratories and public health, healthcare, and hospital systems having the capacity to test for COVID-19 in every community throughout the country. After robust testing capabilities are available, we will better be able to determine where and when it is safe to gradually loosen stay-at-home orders and restrictions on gatherings.

“Additionally, rapid manufacturing and production of PPE is needed to exponentially expand in settings where infection and transmission may be highest including hospitals, nursing homes, skilled nursing facilities, correctional facilities, grocery stores, and other venues where people congregate. Expanding PPE access to every necessary setting will protect those who are responding to COVID-19 today, but expansion will also be critical for preventing future COVID-19 transmission and lowering community transmission rates.

Our nation’s recovery from COVID-19 will be based on the rapid production of testing supplies and PPE. Now is the time for every company that can to produce these vital materials to help save American lives.”

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Dear public health lab staff: Thank you!

Wisconsin public health lab staff hold signs that say "We stay at work for you; please stay at home for us"

By Scott J. Becker, CEO, APHL

This week is National Public Health Week, a time to celebrate all the ways public health professionals keep our communities safe and healthy. This year, with a novel disease circling the globe threatening our health and disrupting our lives, the observance takes on even greater significance.

I’ve heard so many emotional and passionate stories about our collective response to COVID-19 that I could fill a book. Laboratory staff who are on call around the clock, working extra shifts and weekends to meet demand. Public health laboratories collaborating with clinical and commercial labs to verify results and help expand urgently needed testing capacity. Lab directors advocating with their elected leaders to ensure limited tests and supplies are prioritized for those who need them most. All of this while trying to keep yourselves and your families healthy and safe in this uncertain time. Everyone’s steadfast commitment to quality laboratory systems is abundantly clear.

You are inspiring and we celebrate you!

Send us your stories

To help us honor this important work and recognize the remarkable dedication of public health laboratory staff, we’re asking for your photos, videos and stories reflecting your personal staff experiences during this response. These don’t need to be elaborate or perfectly polished. Simple statements and depictions of what it’s like to work in a public health lab right now are perfect. Submissions can even be anonymous, without any names or jurisdictional information. We will share these on our social networks, blog, website and other ways. We’d love to have stories reflect experiences from across the entire laboratory workforce spectrum — from your facility and maintenance staff, to those working data entry and accessioning, to the scientists on bench and in full PPE, to the director’s office and everyone in between. Please email eoc@aphl.org to share or for more information.

We’ve also joined partners in a new effort to tell the stories of public health professionals through short videos. The website WhyPublicHealthMatters.org allows anyone anywhere to quickly record and upload a 60-second video with a smartphone, tablet or computer. By sharing your video about your experience during the COVID-19 response, you can help inspire others and build support for public health.

Even in the midst of our pandemic response, fraught with so many challenges and so much risk, there is reason to celebrate our staff and their incredible work across the laboratory. National Public Health Week reminds us of that.

Thank you for your extraordinary work!

Photo: Wisconsin State Laboratory of Hygiene scientists take a quick break from COVID-19 virus testing to send a reminder to Stay Safer at Home.

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Coronavirus stimulus provides key investments in public health

US Capitol at dusk

FOR IMMEDIATE RELEASE

Silver Spring, MD, March 27, 2020 — The emergency aid package passed by Congress today makes key investments in public health, according to the Association of Public Health Laboratories (APHL). The measure, designed to bolster US response to the coronavirus (COVID-19), includes a tenfold increase to improve the management of public health data and a substantial boost in funding for state and local health departments, including public health laboratories.

“Public health department and laboratory staff have been on the front lines helping to protect our communities from this novel disease threat. They are over-burdened and short on critical supplies,” said Scott Becker, CEO of APHL. “This stimulus package provides important funding that will help strengthen our nation’s response to the pandemic and other pressing health challenges.”

The measure includes $500 million for the Centers for Disease Control and Prevention (CDC) to improve the management of public health data. This funding will help develop and deploy data and analytics that scale rapidly in emergencies, provide predictive capacity to identify emerging threats, ensure two-way information flow and more to better detect and monitor disease threats.

The bill also provides $1.5 billion to CDC to fund state and local health departments and their laboratories, in addition to the $950 million already provided for these activities in the first supplemental funding package. It will strengthen these critical agencies to enable them to respond nimbly to public health emergencies, including COVID-19.

“If we’ve learned anything during the first months of our COVID-19 response it’s that monitoring, testing for and tracking disease and preparing our communities for health threats are absolutely essential functions and must not be taken for granted,” said Becker. “This stimulus package includes long-overdue funding to help protect us against COVID-19 and other potential health threats.

“We look forward to the president enacting this measure and to our continued work with the administration and Congress to ensure adequate and sustained funding to protect public health.”

APHL also joined partners in issuing a statement applauding members of Congress for providing $500 million for the Data Modernization Initiative at the Centers for Disease Control and Prevention (CDC) that will transform public health data systems and save lives.

Contact: Michelle Forman at 240.485.2793 or michelle.forman@aphl.org

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The Association of Public Health Laboratories (APHL) works to strengthen laboratory systems serving the public’s health in the U.S. and globally. APHL’s member laboratories protect the public’s health by monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist agents, genetic disorders in newborns and other diverse health threats. Learn more at www.aphl.org.

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APHL and partners: COVID aid package provides much needed funding for data modernization

Data illustration

FOR IMMEDIATE RELEASE
March 27, 2020

Washington, D.C. – Together, the Association of Public Health Laboratories (APHL), Association of State and Territorial Health Officials (ASTHO), Council of State and Territorial Epidemiologists (CSTE), Healthcare Information & Management Systems Society (HIMSS), National Association of County and City Health Officials (NACCHO), and National Association for Public Health Statistics and Information Systems (NAPHSIS) issued the following statement in response to the Coronavirus Aid, Relief, and Economic Security (CARES) Act:

We applaud members of Congress for providing $500 million for the Data Modernization Initiative at the Centers for Disease Control and Prevention (CDC) that will transform public health data systems and save lives.

The nation faces an unprecedented challenge to address the COVID-19 pandemic. Now, more than ever, it is critical to have a strong public health surveillance system that detects and facilitates immediate responses and containment of emerging health threats. The CDC—together with state, local, territorial, and tribal health departments—have taken important steps to improve the nation’s public health data infrastructure, but due to funding shortages, this has often been in a piecemeal approach.

The COVID-19 pandemic has exposed gaps in our nation’s outdated public health data systems and a workforce struggling to keep up. The United States currently relies on error-prone, sluggish and burdensome manual and paper-based data exchange methods such as faxing and phone calls to share critical public health data, especially with the health care sector. Simply put, the virus is moving faster than the data and when data move more slowly than diseases, the American people suffer. We are watching as our leaders struggle to make critical decisions without complete data.

An integrated, high-speed, networked health system—from laboratories to health care facilities to public health authorities—with fast and reliable data is necessary in order to protect Americans from COVID-19 and future health threats. Modernization is not just network upgrades; it is a commitment to building and sustaining a world-class data workforce and data systems that are ready for the next public health emergency. The funding provided in the CARES Act is an enterprise-level commitment to build a public health data superhighway of the 21st Century to speed the transmission of accurate, complete data.

We look forward to working with Congress to ensure sustained annual funding for CDC’s Data Modernization Initiative and with CDC in formulating its multi-year implementation plan.

Contact:  Erin Morton at 202.484.1100 or emorton@dc-crd.com

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COVID-19 Testing Needs to Be Limited to Priority Groups Until Sufficient Testing Supplies and Personal Protective Equipment is Available Nationwide

Prioritize testing for COVID-19 image

The Association of State and Territorial Health Officials (ASTHO), Association of Public Health Laboratories (APHL) and Council of State and Territorial Epidemiologists (CSTE) issued the following policy recommendations regarding testing for the novel coronavirus (COVID-19).

Due to the widescale shortages of laboratory supplies and reagents, we strongly urge public health and healthcare professionals to prioritize COVID-19 testing among three specific groups:

  1. Healthcare workers and first responders with COVID-19 symptoms.
  2. Older Americans who have symptoms of COVID-19, especially those living in congregate settings.
  3. Individudals who may have other illnesses that would be treated differently if they were infected with COVID-19 and therefore physician judgement is especially important for this population.

Testing for individuals outside these three groups is not recommended until sufficient testing supplies and capacity become more widely available.

Community-based COVID-19 testing (drive-through, walk-up, etc.) should be focused on making tests available to the three priority groups above. The goal of providing these community-based testing sites is to limit potential introduction of COVID-19 in healthcare and congregate settings.

While some communities may have sufficient testing supplies and/or personal protective equipment (PPE) to expand COVID-19 testing to other groups, mass testing of any American for COVID-19 at this time will quickly deplete the existing supply of testing reagents, laboratory supplies, and PPE needed to manage patients in clinical, in-patient and other residential settings.

Healthy individuals who are not able to get tested should practice social-distancing and follow the recommendations of their local and state public health authorities. Individuals with mild illness should stay at home, practice self isolation, monitor their health and manage their symptoms using self-care, and contact their health care provider if their symptoms get worse.

For more information on COVID-19, including guidance and guidelines for healthcare and public health professionals, visit: www.cdc.gov/covid19

For more information on ASTHO, including resources for state and territorial health agencies, please contact preparedness@astho.org, or visit https://www.astho.org/COVID-19/.

For more information on APHL, please contact info@aphl.org or visit www.aphl.org/COVID-19.

For more information on CSTE, visit www.cste.org or call 770-458-3811.

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APHL CEO to his kids: We will get through this. Now go wash your hands.

Photo of a high school campus

By Scott J. Becker, CEO, APHL

I’m a dad to two girls – one in high school and one in college – both of whom are home as their schools respond to the COVID-19 outbreak. They asked me to share some info with their friends and I thought it would be helpful for other kids wondering about the same things.

I wanted to provide a little reality check for all of you who are now experiencing this major disruption to your lives. Yeah, it sucks. No way around that. I want to try to help by providing you with some context and terminology so you can make good decisions and full understand what’s happening right now.

What is COVID-19? It’s the disease caused by SARS-CoV-2, which is the official name of this new coronavirus. (Virologists worldwide would be furious if I didn’t mention that!) I’ll refer to it as COVID-19, much easier to say (use #COVID19).

First off, this week the World Health Organization (WHO) in Geneva announced that COVID-19 is officially a pandemic and that there are over 118,000 cases worldwide. A pandemic is simply the global (multiple regions of the world) spread of a new disease that is easy to pass from person to person in an efficient and sustained way. Nothing new there, right? We’ve seen this disease spread over the last few months, first in Asia and then in other spots around the world such as Italy, Iran, Seattle, etc. An epidemic, on the other hand, is the spread of a disease within a specific community. Think of a measles or mumps outbreak on a college campus, or a foodborne outbreak associated with contaminated sprouts (just don’t eat sprouts, they are notorious for making people sick). You have also heard about the transmission on cruise ships.  I think of cruise ships as “floating petri dishes” on a good day. In this instance, having thousands of people on cruise ships at the outset of an epidemic or pandemic was also a pretty efficient mechanism to further circulate the virus.

So what can you do? First, recognize that this situation is serious. We have had very few pandemics in the past 100 years! Also remember that our healthcare and public health systems are much better than they were way back then. We will get through this.

What are we trying to do now? Put simply, we are trying to use important public health tactics to flatten the epidemic curve for COVID-19. The “epi curve” is what we see as case counts go up and then eventually come down. We are trying to buy ourselves time to reduce the curve of illness. Another way to say it is that we are trying to break the chain of transmission.

There are many ways to help yourself and your community (friends, family, especially older people). I was embedded with CDC earlier this week, I have worked closely with my colleagues there throughout this outbreak just as I have for my entire career. The site I linked to above (here it is again) is accurate and extremely helpful. Please, please, please read it.

Handwashing is one of the best ways to protect yourself and your family from getting sick. Wash your hands often with soap and water for at least 20 seconds (scrub for 20 seconds!), especially after blowing your nose, coughing or sneezing; going to the bathroom; and before eating or preparing food. If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol. In my experience, soap and water are easier to find right now than hand sanitizer and it works better anyway.

Please clean your cell phone. Really. That’s another place where viruses love to hang out.

Stop touching your face. Much harder to do than it sounds.

Social distancing – yeah, this might mean that you won’t be going to concerts and other events for a while. Good thing you all are so good at staying connected over social media, etc. Remember, this isn’t only about you – it’s about everyone. You don’t want to be the vector that infects a whole bunch of vulnerable people! That’s why many nursing homes around the nation aren’t allowing in any visitors.

Okay, so it feels like it really sucks to be you right now. Major disruption in your lives, online classes (hopefully that will work out okay), no large gatherings, etc.  In reality, it sucks to be all of us right now. This is why public health matters – it’s the health of the public, all of us, that really matters. And here it comes: we’re all in this together. This too shall pass. My wife and I have known many of you since you were little. You are all resilient. You will learn from this and come out stronger on the other side. And maybe some of you will go into the public health field (at least think about it)!

Stay well and stop touching your face. Now go wash your hands.

Scott

@scottjbecker @aphl

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