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SCAN Project Update May 14, 2020
Thank you for your interest in the Seattle Coronavirus Assessment Network (SCAN). Our testing of home-based, self-collected samples for COVID-19 is currently paused. We sincerely apologize for the inconvenience.
SCAN’s test is authorized by the Washington State Department of Health. However, the Food & Drug Administration (FDA) recently clarified its guidance for home-based, self-collected samples to test for COVID-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests. The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization.
We have been in conversation with the FDA since March 1st and hope to have our EUA soon. We initiated the process to authorize our lab-developed test and self-swab kit on March 23rd and, in accordance with the EUA process and timeline, submitted data to secure federal authorization on April 13th. We are actively working to address their questions and resume testing as soon as possible.
We are pleased to see the FDA’s recent clarifications regarding provisions for home-based self-collection of diagnostic samples in specific circumstances. This paves the way toward expanding access to safe, reliable, convenient, and scalable testing options across the country.
We are grateful for productive partnerships with the FDA, the Washington State Department of Health, and the Centers for Disease Control and Prevention as we continue to respond to this unprecedented and rapidly evolving outbreak.
In the meantime, you can still help us understand how COVID-19 is spreading by taking our optional community survey. We’re asking people interested in supporting SCAN’s work to answer a few questions about their own or their children’s health. It should only take a few minutes to complete. Your anonymous responses are not linked to you individually and have no impact on whether you can receive a SCAN swab kit in the future.
If you’d like to participate, please click "START".
Frequently Asked Questions:
Q: Why did SCAN pause so suddenly? Was there something wrong with the test?
A: There are no issues or concerns with the safety and accuracy of SCAN’s test. Laboratories applying for an Emergency Use Authorization from the FDA are often asked to provide additional information to support their test application.
The FDA recently clarified its guidance for home-based, self-collected samples to test for SARS-CoV-2, the virus that causes COVID-19. These requirements establish common guidelines for at-home testing in the United States.
While SCAN’s test remains authorized by the Washington State Department of Health, we have been notified that a separate federal emergency use authorization is required to return results for tests of self-collected specimens. On May 12th, the FDA asked that we pause testing until we have received this additional authorization.
SCAN is working with the FDA and Washington State Department of Health to resume testing and notification of results as soon as possible.
Q: I submitted my swab after May 8th / before May 13th: will you be able to tell me my results?
A: Unfortunately, our testing of home-based, self-collected samples for COVID-19 is currently paused, and we cannot return test results at this time. SCAN is working with the FDA and Washington State Department of Health to resume testing and notification of all past results as soon as possible. Please check our website for updates as they become available.
If you are severely ill, such as having trouble breathing, or believe you have been exposed to someone who has tested positive for COVID-19, please contact a doctor or healthcare provider right away.
Q: What data have you submitted to the FDA?
A: The agency has requested data regarding SCAN’s use of mid-turbinate nasal swabs. We have submitted data validating the safety of these swabs for home-based collection, as well as the reliability of our lab-developed test for specimens collected using our self-swab kits.
We have performed internal studies to determine shipping and specimen stability with our assay, testing approximately 17,000 home-collected mid-turbinate swabs from both adults and children—including Seattle Flu Study and SCAN samples. We have provided the following information to the FDA:
- To date, only a single, minor adverse event has been reported.
- Our shipping and stability studies have established that detection of SARS-CoV-2 is stable for over a week at high and low regional temperatures.
- With regard to proper specimen collection outside of a clinical setting, our experience from more than 18 months of sampling with the Seattle Flu Study and now SCAN also shows a low rate of insufficient nasal sampling. The internal control in our assay readily identifies whether a sufficient specimen is collected.
Numerous scientific studies have established similar rates of detection for mid-turbinate swabs and the nasal pharyngeal swabs typically used in clinical testing, including for SARS-CoV-2 detection. The Infectious Diseases Society of America (IDSA) guidelines endorse the use of mid-turbinate swabs and reference the potential for self-collection with appropriate instructions.
Q: What other questions has the FDA raised?
A: We have been asked about our testing of people who have not reported COVID-like illness (CLI). Since community sampling began on March 23, SCAN has tested 7,106 samples from respondents with self-reported CLI and 5,376 samples from respondents not reporting CLI symptoms.
It has been established that COVID-19 can spread even among those who are asymptomatic. It’s important that SCAN collects data on the pathogen from people who feel sick enough to seek care (but are not suspected of having COVID-19) as well as those not seeking care, who are mildly ill or not ill at all. This can not only help us learn more about the virus, it can help us identify positive cases of COVID-19 that might otherwise go undetected.
Q: I’m currently enrolled in the SFS household study. Has that been paused?
A: The SFS household study continues. Although the household study involves home-based collection and return of results, the program is an approved research study supervised by an Institutional Review Board (IRB). The SFS research household studies therefore fall under a separate FDA Policy for COVID-19 tests than SCAN.
Q: Are you also pausing your testing in homeless shelters and long-term care facilities?
A: Our work in homeless shelters and long-term care facilities continues. These are separate research studies under the banner of the Seattle Flu Study. Samples are collected under the supervision of a health care worker and do not involve home-based self-collection.