Dr. Helen Chu, an infectious disease expert at the University of Washington, and her team began the Seattle Flu Study (SFS) in 2018. According to Dr. Chu, “The objective of the Seattle Flu Study was to develop a pandemic surveillance platform that could be used to identify new pathogens and develop strategies for rapid containment of spread, before the months to years it would take for a vaccine to be developed.”
When COVID-19 concerns began circulating in the US, the SFS team was ready to respond. As part of the study, the team had been collecting nasal swabs from residents of the Puget Sound region with flu-like symptoms for months. Dr. Chu began testing samples for SARS-CoV-2, and two days later, a positive sample was identified and confirmed by the WA Department of Health. On February 24th, this positive sample from an individual with no travel history would mark the first documented case of community transmission in the United States.
Lab testing at SFS was not CLIA-licensed at the time, a type of regulatory licensure given to clinical labs. Therefore, per FDA guidelines, the SFS team was not allowed to return results to participants because of the risk of returning an unvalidated research result. The procedure to obtain Emergency Use Authorization for testing was also put into place on February 29, 2020, after the samples were tested.
This put the SFS team in a challenging position, requiring them to face questions like:
Is it ethical to withhold the results of a test that could potentially alter the course of an individual’s illness and society’s trajectory?
During a pandemic, which is a public health emergency, is there a way for us to be able to repurpose research activities for public health?
Ultimately, the team decided to return the test result to the participant. On March 2nd, the institutional review board at the University of Washington also determined that given the public health emergency, SFS had an ethical obligation to test all samples for SARS-CoV-2.
The project has since grown into the Greater Seattle Coronavirus Assessment Network Study (SCAN), which has sent more than 17,500 free swab-and-send home testing kits to symptomatic and asymptomatic residents in the Seattle region. In addition to identifying those with COVID-19, the data collected has helped researchers learn more about the virus and its spread.
This study and response to the pandemic illustrate the importance of proactive collaboration across public health, government, and private entities. More importantly, it has brought to light the importance of community virus surveillance. SFS’s early work in preparing for a pandemic enabled them to immediately begin assessing the spread of COVID-19 in the Seattle region, thereby accelerating public health efforts to mitigate the emerging pandemic.
Helen Chu MD Associate Professor, University of Washington