The Seattle Coronavirus Assessment Network today resumed its at-home COVID-19 testing campaign, nearly a month after the program was suspended due to regulatory snags.
Public Health – Seattle & King County announced that the research study could go forward with the approval of an institutional review board and oversight by the University of Washington, Seattle Children’s and the Fred Hutchinson Cancer Center.
“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,” Jeff Duchin, health officer for Public Health – Seattle & King County, said in a blog posting. “This data can inform public health decisions in the weeks and months to come as King County takes steps to increase activities and get back to work.”
Winning the review board’s approval cleared up an issue that led SCAN’s organizers to put the project on pause on May 12.
When the project was launched in late March, it was operating under guidance from the Food and Drug Administration that gave state public health officials the authority to approve testing procedures on an emergency basis.
That guidance changed last month, with the result that SCAN required separate FDA authorization to use its at-home, self-collected tests for diagnostic purposes. SCAN began the process to secure the required authorization back in March, but the process hasn’t yet been completed.
In the meantime, self-collected specimens can be used for research purposes — as long as the procedure is explicitly approved by an institutional review board, or IRB. “Under IRB approval and oversight, SCAN is able to return test results to individuals,” the organizers told GeekWire in an email.
SCAN says the safety and accuracy of the test has been verified based on its experience with more than 17,000 home-collected samples, including samples that were analyzed for a separate project called the Seattle Flu Study.
Going forward, participants in the study will be asked to fill out a consent form that’s longer and more detailed than the previously used permission form.
Because the conditions have changed, SCAN won’t be able to return test results for samples that were submitted before the pause. “The team understands this is frustrating and will contact impacted individuals directly with more information,” public health officials said.
Anyone can apply to participate in the project via SCAN’s website, whether or not they’re sick. But not all who apply will be chosen to participate. SCAN is using strategies to prioritize child enrollment, as well as appropriate representation based on age, geographic region, race and ethnicity, income and primary language.
Between March 23 and May 9, the program analyzed 12,482 self-collected samples and identified 102 positive results for COVID-19. Out of those 102 cases, 87% of the respondents had not sought in-person clinical care before enrolling in SCAN — either because they didn’t consider their symptoms to be serious enough, or because they lacked access to health care services.
Among other findings reported by SCAN’s researchers:
- COVID-19 prevalence in King County appears to have peaked in late March, declined rapidly during the first half of April, and declined more slowly since then.
- SCAN participants in south King County had a higher proportion of positive test results than residents in north King County.
- SCAN participants living in larger households were more likely to test positive for COVID-19, and when one participant tested positive, subsequent participants from the same household were more likely to test positive as well.
Leading up to the pause, children were significantly underrepresented in the sample group. SCAN’s researchers want to increase the representation of children in their sampling, as well as the representation of south King County residents and people in key census classifications such as American Indian, Black, Hispanic/LatinX, Native Hawaiian and Pacific Islander.
“The insights we gain from broad-based community testing are highly valuable to inform our public health response as this outbreak continues,” said UW professor Jay Shendure, who serves as scientific director of the Brotman Baty Institute and lead principal investigator for the Seattle Flu Study.
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SCAN is a partnership between the Seattle Flu Study and Public Health – Seattle & King County. It’s funded by Gates Ventures, the private office of Bill Gates, and is getting technical guidance from experts at organizations including the Bill & Melinda Gates Foundation and the Centers for Disease Control and Prevention.
The Institute for Disease Modeling provides data modeling support. Amazon Care, the health care program for Amazon employees, is providing logistical support for delivering and picking up at-home collection kits.
The Seattle Flu Study was developed by the Brotman Baty Institute in league with UW Medicine, the Fred Hutchinson Cancer Research Center and Seattle Children’s.
Public Health – Seattle & King County notes that SCAN is a respiratory virus monitoring program and not a clinical service. If you believe you either have COVID-19 or have been in contact with someone who has tested positive for the virus, please stay home, contact your health care provider, and follow public health guidance.
If access to health care is a problem, you can get tested for COVID-19 for free at King County’s open-access testing locations. Call 206-477-3977 for more information. If you’re interested in supporting SCAN’s effort to widen its outreach, you can send email to info@scanpublichealth.org.
