A Different Kind of COVID-19 (Sero)Survey

One of the many difficulties of COVID-19 is knowing who has had it. Not everyone who is infected develops symptoms, and not everyone who has symptoms gets a diagnostic test for the presence of SARS-CoV-2, the virus that causes COVID-19. But knowing how many people in a community have been infected is critical for understanding the spread of the virus and how long people may remain protected after infection. This ability to take an observation and turning it into an intervention that may benefit the public is a prototypical translational science problem that can be solved only by a team composed of members with diverse expertise working together — which is exactly what NCATS has catalyzed over the last several months.

Past infection is inferred from the presence of an immune response — principally antibodies — in the noncellular part of the blood called “serum.” Surveying large numbers of people for the presence of such antibodies is therefore called a “serosurvey.” Testing the same people over time can provide insights into how long antibodies remain after infection and how long people may remain protected from another infection.

NCATS scientists initiated the serosurvey project in mid-March by forming a team of laboratory scientists, epidemiologists, statisticians and infectious disease clinicians from NCATS, the National Institute of Allergy and Infectious Diseases, the National Institute of Biomedical Imaging and Bioengineering, and the Frederick National Laboratory for Cancer Research. The first step was developing and validating highly sensitive and specific assays (assay 1(link is external), assay 2(link is external), assay 3(link is external)), or tests, that would indicate the presence of SARS-CoV-2 antibodies in serum. The team initially planned to test about 400 people, but interest was so high across the country that the team rapidly increased throughput of the assay and automated it, allowing testing of more than 10,000 people.

Given the great interest from the public in joining this study, NCATS-funded Clinical and Translational Science Awards Program hubs at the University of Pittsburgh and the University of Alabama were brought in to expand enrollment capacity and diversity among the study’s participants. The existing resources and infrastructure at these hubs enabled screening of more than 400,000 potential participants to ensure a broad, diverse study population. In a first for NCATS, we repurposed a tool used by our administrative division to create a map-based dashboard to see who was enrolling and dynamically adjust enrollment efforts to ensure study participants reflect the demographics of the country. The Rare Diseases Clinical Research Network is now joining the effort so that the results can inform rare diseases research and clinical care planning for medically vulnerable rare disease populations during public health emergencies.

This project exemplifies NCATS’ translational science principles of innovation, rapid adaptation, collaboration and inclusivity, as well as our “3Ds” paradigm: We helped develop the testing assay, demonstrated its usefulness in a large population, and have disseminated the platform to others; results will be made public as soon as they are complete — which we expect in a month or so. The National Cancer Institute will be supporting a longitudinal study to re-sample study participants every 6 months, which will tell us an enormous amount about how long antibody levels remain high post-infection.

Watch this video to learn more about how the team came together quickly to carry out this important work. If you’re interested in learning more about the serosurvey itself, please visit clinicalstudies.info.nih.gov/ProtocolDetails.aspx?id=2020-I-0083(link is external) or email clinicalstudiesunit@nih.gov(link sends e-mail).