Georgia CTSA and Emory University including the Emory Medical Laboratory assisted the Centers for Disease Control and Prevention (CDC) and the Federal Emergency Management Agency (FEMA) in conducting a serosurvey to assess the presence of antibodies to SARS-CoV-2 among their workforce who are participating in the COVID-19 response. Georgia CTSA completed more than 1,200 blood draws for a COVID-19 serology (antibody) testing for CDC first responders and Emory Healthcare staff for the COPE study. Additionally, Georgia CTSA helped test 476 blood samples from FEMA and HHS first-line responders stationed in Washington, DC for a total of just under 1,700 tests.
A serosurvey includes testing of blood serum from a group of individuals. A serology test looks for the presence of antibodies, which are specific proteins made in response to infections. In this case, it is to assess the presence of antibodies to SARS-CoV-2, the virus that causes COVID-19. If the test detects the presence of antibodies in an individual, it would suggest that he or she may have previously been infected or exposed to the virus that causes COVID-19, even if he or she did not have symptoms of infection.
The purpose of this investigation is to learn from responders if their blood contains antibodies against SARS-CoV-2 to better understand their risk for disease with new exposures during future participation in the response to the COVID-19 pandemic, learn about risk factors for contracting SARS-CoV-2 infection while working on the response, better understand the range of symptoms of SARS-CoV-2 if they became infected while participating in the response, and assess the presence of antibodies in response to symptomatic or asymptomatic disease associated with SARS-CoV-2 infection.
Results of this investigation provide participants with information about the detection of antibodies against SARS-CoV-2 in their blood, provide CDC and FEMA with information about activities that may increase the risk of infection among their workforce, will guide recommendations to protect their workforce when working in an emergency response, and provide a better understanding of how people develop an immune response against SARS-CoV-2.
While FEMA responders had their blood draws taken near Washington, DC and shipped to the Emory lab for testing, Georgia CTSA Clinical Research Center (GCRC) staff scheduled an appointment for each CDC participant, and the GCRC nurses and phlebotomists collected the blood samples to test for antibodies against SARS-CoV-2. Blood draws took place near the CDC Roybal campus in Atlanta and each participant received the results of their test in the mail.
In a letter to each participant with their test results, John D. Roback, MD, PhD, Professor of Pathology & Laboratory Medicine, and Director, Emory Medical Laboratories, thanked each responder who participated in this important public health surveillance investigation to assess the extent to which CDC staff had been exposed to SARS-CoV-2. Roback explained that the serum sample provided was tested using an Emory Medical Laboratories (EML) developed serologic assay for IgG antibodies against SARS-CoV-2, the virus implicated in the COVID-19 pandemic, using an ELISA method. This test detects antibodies against the receptor-binding domain of the SARS-CoV-2 spike protein.
“This study was crucial to determine the prevalence of past infection with COVID-19 amongst CDC staff that had participated on the front line of the public response to the pandemic. The Georgia CTSA team worked long hours to ensure quick reviews and submission of protocols, contracts, and documentation by numerous departments,” comments Concepcion F. Estivariz, MD, Epidemiologist, Global Immunization Division, CDC. “Georgia CTSA also quickly adapted with changes in human resources necessary to handle the unexpectedly high number of individuals who wanted to enroll in the project. Andrew West, Georgia CTSA Senior Center Administrator, successfully coordinated scheduling and social distancing measures to ensure that all participants went through the clinic visit procedures quickly and safely. He found solutions to ensure all staff had adequate personal protective equipment despite a nationwide supply shortage. Additionally, he also coordinated daily calls with all stakeholders to follow up on progress and quickly troubleshoot any problems and challenges.”
Andrew C. West, MBA, MHA, Georgia CTSA Senior Center Administrator, led the Georgia CTSA team in making the arrangements for the facility and materials for the blood draws, arranging Georgia CTSA Clinical Research Center (GCRC) phlebotomists to conduct the draws, working with several departments for project approval and coordinating the ongoing efforts of many groups. “Our phlebotomists needed face shields, so our partners at UGA made us face shields. We needed hand sanitizer, so the Emory Department of Chemistry made that for us using the WHO recipe,” says West. “It was a significant team effort with involvement from all of the following plus many others: Georgia CTSA, UGA College of Engineering, Emory Campus Services and Police, Department of Chemistry, Endocrinology, Facilities Management, Human Genetics, LITS, Neurology, Office of Clinical Research, Office of Critical Event Preparedness and Response, Office of Sponsored Programs, Pathology, Pathology RAS, Spiritual Health, Staging, Temporary Services; Bearcom Radio Rental, Emory Point Property Management, LAZ Parking, Orkin Pest Control, and Ricoh Management Services.”
GCRCs Nursing Director Rebecca Shelton-Thomas, DNP, RN, oversaw the GCRC phlebotomists, staff, and participants during the daily blood draws for several weeks and explains, “One of the things that was most humbling to me is how everyone pulled together. We were able to set up our clinic in a new location in a couple of days to see these participants. Everyone banded together to help us, which was amazing because it wasn’t only Emory Healthcare, it was staff from the entire university.”
“The CDC employees would tell us what their role was as first responders, and their stories were remarkable. One lady had been on the Princess Cruise line and was wearing full PPE. At the beginning of the COVID pandemic, I wondered, ‘How am I going to give back?’ This project was a way for not only me but also all of the GCRC nurses to be directly involved in helping with serology testing and what that could mean for managing the pandemic. Not only were we performing the blood draws for the CDC workforce, but we also conducted the draws for the Emory Healthcare COPE study. It was an honor for us to be able to help do our part.”
For the COPE study led by Drs. Matt Collins and Scott Fridkin, both of Emory Infectious Diseases, there will also be follow up in the GCRC unit. GCRC will conduct a three-month, six-month, nine-month, and twelve-month follow-up to study Emory Healthcare employees who are working in COVID areas. The main purpose of the COPE study is to gain knowledge about how often SARS CoV-2 infection occurs in healthcare personnel and understand whether infection may result from exposures related to certain occupational activities or patient encounters.
“We came together as a team towards this common goal, to be able to advance. This is the first time that we’ve had serology or any type of testing like this in the middle of a pandemic. Georgia CTSA and the GCRC has made a vital contribution in helping advance the knowledge surrounding this virus,” adds Thomas. “Not only did these protective supplies help during the initial phase of the pandemic, but now that we’re ramping up our normal clinical research, we have an extra layer of protection for our nurses. Dr. Robert Taylor, Georgia CTSA Contact Principal Investigator, connected us with someone in the Emory Department of Chemistry to make hand sanitizer because we didn’t have hand sanitizer. The building staff helped us procure Clorox wipes because Emory University Hospital didn’t have any, and they couldn’t be ordered from Amazon or Staples. From the staff who thoroughly cleaned our facility every day to Emory’s Provost who permitted us to use this facility near the CDC to conduct the blood draws and everybody in between helped make this possible.”
“I am really proud of the clinical staff of the GCRC; they nimbly set up an entire infrastructure for these important studies and provided great customer service,” remarks Colleen Kraft, MD, GCRCs Director, Associate Chief Medical Officer at Emory University Hospital and Associate Professor of Infectious Diseases and Pathology at Emory University School of Medicine.
Georgia CTSA’s multi-site Georgia CTSA Clinical Research Centers (GCRCs) is a multilayered, flexible, and geographically distributed network created to meet the needs of translational and clinical investigators from Emory University, MSM, UGA, Georgia Tech, and Children’s Healthcare of Atlanta (Children’s). The GCRCs offers dedicated space and a variety of resources ranging from core laboratory services to a bionutrition unit to support the research process at a subsidized cost. Clinical sites, including nursing services, are located at Emory University Hospital, Grady Memorial Hospital, UGA, MSM, Children’s, and Emory University Midtown.
The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health’s Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. For more information, visit www.GeorgiaCTSA.org.
- clinical research
CTSA Program In Action Goals
Goal 2: Engage Patients and Communities in Every Phase of the Translational Process
Goal 4: Innovate Processes to Increase the Quality and Efficiency of Translational Research, Particularly of Multisite Trials