A coronavirus surveillance program that allows participants to swab their own noses at home is resuming operation, after being shut down a month ago by the U.S. Food and Drug Administration (FDA).
Launched in mid-March with approval from the Washington Department of Health, the greater Seattle Coronavirus Assessment Network, or SCAN, was notified by the FDA in early May that it also needed a federal Emergency Use Authorization (EUA) for the self-swab approach.
The program is still working with the agency to gain authorization.
But in the interim, SCAN is taking advantage of the fact that research studies approved by institutional review boards do not require federal EUAs for the use of self-swab kits.
Now, with approval and oversight from review boards at the University of Washington, Seattle Children’s and Fred Hutchinson Cancer Research Center, SCAN is once again soliciting volunteers across the county — particularly among communities and groups that have not been well-represented and who might be at higher risk of contracting the virus.
Before it was shut down, the program collected 12,482 swabs, which participants ship to a central lab for analysis. Of those, 102 were positive for the novel coronavirus, said a blog post from Public Health — Seattle & King County. The vast majority were among people who had not gone to a doctor or clinic, either because their symptoms were not serious or because they lacked access to health-care services.
Extrapolating from results through the first week of May, SCAN estimates 3,000 to 10,000 people across the county had active infections during that time, a rate of 15 to 46 per 10,000 people.
“SCAN continues to provide an important and unique window into the COVID-19 outbreak across King County, and in its next phase will also help us expand access to testing for at-risk groups,” Dr. Jeffrey Duchin, health officer for Public Health — Seattle & King County, said in the blog post.
The results also show a higher proportion of positive tests from South King County and among people who live in larger households — particularly households where another person is infected.
The program is stepping up efforts to recruit participants from under-represented, but often disproportionately impacted, groups, including Black, American Indian, Hispanic, Native Hawaiian and Pacific Islander communities. The program also will focus more testing on children.
“As more volunteers enroll in SCAN, we are able to draw increasingly helpful insights from the data…,” said Dr. Jay Shendure, project leader and scientific director of the Brotman Baty Institute at the UW. “The insights we gain from broad-based community testing are highly valuable to inform our public health response as this outbreak continues.”
Shifting to a research-study format means participants now will have to fill out lengthier, online consent forms, the blog post says. All new participants will be notified of their test results.
But because of FDA’s requirements, SCAN is not allowed to share testing results with people who submitted samples shortly before the program was temporarily suspended May 12. The blog post says the researchers will notify those people.
More information on the program, including how to participate, is available at: https://scanpublichealth.org/