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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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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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: Expanding Testing Capacity for COVID-19 Greatly Bolsters U.S. Public Health Response

Public health laboratory scientist performing RT-PCR testing

FOR IMMEDIATE RELEASE
For more, contact Michelle Forman at 240.485.2793 or michelle.forman@aphl.org

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

Silver Spring, MD, February 29, 2020 — “Today the Food and Drug Administration announced new guidelines to increase U.S. capacity for diagnostic testing for the coronavirus that causes COVID-19.

“Previously, only public health laboratories that could verify test kits issued by the Centers for Disease Control and Prevention were permitted to test for the virus. This new guidance allows any CLIA-certified, high complexity laboratory to go through the process to become certified to test.

“This will allow the laboratory community to cast a wider net and enable testing in more communities across the country and bolster U.S public health response.

“We are greatly encouraged by expanding the testing capacity to the clinical laboratory community. We also recognize the importance that testing for COVID-19 must be done in close coordination with public health counterparts. This is necessary to ensure that tests are performed to quality standards; cases are not missed or misdiagnosed; hospitals doing testing are effectively isolating patients with positive results; and proper follow-up is conducted, including contact tracing.

“Today’s announcement comes in addition to guidance released earlier this week that permits public health labs to expand testing. As a result, we anticipate public health laboratories will have the capacity to conduct 10,000 tests a day by the end of next week. CDC is also manufacturing new test kits that are expected to be distributed to public health labs next week.

“Taken together, these steps will jump-start testing and surveillance capabilities and greatly enhance our efforts to protect the health of individuals and communities across the country.

“We look forward to continuing to work with our partners at CDC, FDA and in the public health and clinical laboratory community as we respond to this public health emergency.”

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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.

 

Photo credit: California Department of Public Health

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APHL and Partners Urge Emergency Funding to Bolster Novel Coronavirus Response

US Capitol Building

FOR IMMEDIATE RELEASE
Contact: Michelle Forman, 240.485.2793

Silver Spring, MD — In a letter to the White House and Congress, the Association of Public Health Laboratories (APHL) and partners today requested supplemental appropriations to expand and strengthen public health capacity and coordination in response to the novel coronavirus outbreak.

“While it is too early to reliably predict the additional cost burden and supplemental needs of the COVID-19 response … we anticipate that an initial supplemental is warranted to respond to public health agencies’ critical need to rapidly detect changes and control the outbreak,” the organizations wrote.

The groups outline several urgent priorities, including funding for the Centers for Disease Control and Prevention (CDC) to support preparedness and response activities; an appropriation for the relevant offices and programs under the Public Health and Social Services Emergency Fund; and authority to reimburse uncompensated care for state and local costs, including obtaining and maintaining quarantine and isolation housing capacity and providing wraparound services.

“We are in the midst of a developing public health emergency,” said Scott Becker, CEO of APHL. “Our request identifies initial needs to bolster our response, but it is likely only the start. Public health laboratories and other critical agencies will need sustained funding to address this growing challenge and other public health threats.”

The letter was signed by APHL, the Association of State and Territorial Health Officials, the National Association of County and City Health Officials and the Council of State and Territorial Epidemiologists.

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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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Media Statement on Novel Coronavirus Public Health Emergency Declaration from APHL Executive Director Scott Becker

Illustration of coronavirus molecule

FOR IMMEDIATE RELEASE

Contact: Michelle Forman at 240.485.2793, michelle.forman@aphl.org
David Fouse, 202.262.5417, david.fouse@aphl.org 

Silver Spring, MD, January, 31, 2020 — “Today the White House declared the novel coronavirus (2019 nCoV) outbreak a public health emergency. Public health laboratories are a critical component of our public health system and are busy supporting the U.S. response.

“Today’s announcement is an important step and makes available critical resources to enhance our public health response. It allows the U.S. Food and Drug Administration to provide an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention so that test kits can be produced and rapidly distributed to public health laboratories.

“Public health laboratories across the country are increasing their readiness by reviewing pandemic preparedness plans, ensuring that necessary equipment and supplies are on hand; scheduling staff to ensure that there is adequate coverage for not only 2019-nCoV but also influenza; coordinating with epidemiologists and clinical labs on rule out testing, specimen referral and results reporting; and in other important ways.

“APHL has stood up our Incident Command System to support our member labs in this response and stands ready to assist our federal, state and local partners in this emergency.”

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The Association of Public Health Laboratories works to strengthen laboratory systems serving the public’s health in the U.S.​​ and globally. Learn more information at www.aphl.org.

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