The University of Washington School of Medicine is moving forward with a new clinical lab test for the COVID-19 coronavirus, and plans to be able to test up to 1,500 samples per day by the end of the week.
Implementation of the test, which will be available only through physicians and healthcare providers, was announced today. The effort follows up on the Food and Drug Administration’s announcement that it would allow labs to develop their own diagnostic tests for the virus under expedited approval.
Also today, the Bill & Melinda Gates Foundation announced that it’s committing an additional $5 million to help public health agencies in the Seattle area enhance their capacity to detect the virus. The response to the coronavirus’ spread was stymied in the Seattle area, where the first U.S. cases were reported, because effective lab tests weren’t available in the first weeks of the epidemic.
Seattle-King County public health officials reported 10 new confirmed cases of COVID-19 today, including one additional death. That brings the total for King County to 31 confirmed cases, including nine deaths. An additional death has been reported in neighboring Snohomish County, and California reported its first coronavirus-related death today.
Over the past couple of weeks, the new lab test has been undergoing development and validation — and on Tuesday, the UW Medicine Virology Lab went live with testing actual patient samples.
The test relies on genetic analysis to detect markers for the COVID-19 coronavirus, also known as SARS-CoV-2, in samples that are taken using nose and throat swabs.
If two genetic markers for the virus’ RNA activity are identified, the test comes back positive. If neither marker is detected, the test is presumptive negative. If only one marker is detected, the test is judged inconclusive. Positive and inconclusive specimens are sent to state public health agencies and the federal Centers for Disease Control and Prevention for further testing.
People cannot refer themselves for testing with the new lab procedure — referrals have to be made by health professionals. UW Medicine cautioned that all results are considered presumptive, and should not be the sole basis for decisions on managing a patient’s condition.
Today’s $5 million commitment from the Gates Foundation follows up on a $100 million contribution to the global effort to respond to the coronavirus crisis. The foundation said it will work with state and local public health officials as well as the CDC to help them enhance their capacity to detect and treat COVID-19 infections, and reduce transmission of the virus.
“The COVID-19 epidemic reminds us that infectious disease respects no boundaries, and no community is immune to the threat of a global pandemic,” Gates Foundation CEO Mark Suzman said in a news release. “We can, however, take steps to mitigate the impact of COVID-19 in Seattle and around the world, and we are ready to support these efforts here in our home community.”
One of the efforts winning support is the Seattle Flu Study, which has been tracking the genetic signatures of coronavirus as it spreads through the Seattle area. The study is led by the Brotman Baty Institute, in collaboration with UW Medicine, the Fred Hutchinson Cancer Research Center and Seattle Children’s Hospital.
The Seattle Flu Study’s mission is to track the spread of infectious diseases, typically influenza, using rapid virus genetic sequencing and evolutionary analysis of transmission chains. Although COVID-19 isn’t a flu virus, it causes flu-like symptoms.
Researchers leveraged data from the study to trace COVID-19’s spread since mid-January, and determined as a result that the virus may have been passed to hundreds if not thousands of people in the Seattle area without being detected.
This phenomenon of “cryptic transmission” underscores the importance of hygiene practices that can reduce the transmission rate — such as washing hands frequently, keeping your hands from touching your face, staying home if you’re sick and avoiding contact with people who are sick.