The Seattle Coronavirus Assessment Network (SCAN) has been sending free tests to people to swab themselves at home to see if they have the CCP (Chinese Communist Party) virus, which causes COVID-19.
After the swab arrived back at the University of Washington, results were available in a couple of days.
In a recent update, SCAN said it was notified by Food and Drug Administration (FDA) officials on May 12 that an emergency use authorization is required, prompting a pause in the program.
“We are actively working to address their questions and resume testing as soon as possible,” the network said. They first submitted data to the agency in March.
An FDA spokesman told The Epoch Times that any at-home test for COVID-19 requires an emergency use authorization.
“The FDA is supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy. This includes demonstrating the ability of a lay user to collect their specimen, run the test, and interpret their results accurately,” he said in an emailed statement.
“We also consider the safety of the consumer, including safety from any exposure to toxic chemicals that may be used in the reaction. FDA encourages developers to discuss with us their validation of home use tests early in their development process.”
While SCAN suggested the FDA recently changed guidance for home-based, self-collected samples, the spokesman said recommendations for at-home testing have not changed. A recent document (pdf) updating policies for testing states that it “does not apply to home collection of specimens” that will be sent for testing at laboratories certified under a program called CLIA.
SCAN said internal studies assessing the stability of specimens turned up only one adverse event, which was described as minor.
“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,” it said in a statement.
SCAN, which has roots in the Seattle Flu Network and is supported by Microsoft co-founder Bill Gates, said workers have seen a low rate of tests that don’t have an adequate sample size over 18 months of testing for the flu and the new virus.
One part of analyzing the results after people’s swabs are received is ensuring a sufficient specimen has been collected.
Gates said in a recent blog post that the network will help researchers find answers to questions including how many people are infected with the CCP virus, including those without symptoms; whether the virus is weather-dependent; and how officials will know when it’s safe to reopen businesses and schools.
“SCAN is testing a sample of people in the Seattle region, including those who are healthy as well as those who are feeling sick,” Gates wrote.
“The test results and other data (like a person’s age, gender, race, zip code, and any underlying health conditions) are used by researchers, data modelers, and public health officials to paint a clearer picture of how COVID-19 is moving through the community, who is at greatest risk, and whether physical distancing measures are working.”
As of late April, 72 samples tested positive out of 8,443 samples, officials said.
The FDA spokesman, meanwhile, suggested SCAN is a research study, not a surveillance study. Research studies conducted under supervision of an institutional review board are handled separately by the agency and a board “may determine that home collection may occur with appropriate mitigations under such a supervised study.”
From The Epoch Times