On March 26, PATH’s Seattle lab opened its doors to COVID-19. Several thousand samples later, the lab has become an invaluable resource in the development and validation of diagnostic tests for COVID-19.
And it all started with a shared sense of urgency and a box.
“When COVID-19 was detected in our community—the first in the United States—we knew immediately that we had to do our part. With PATH’s unique resources and skills, we had an opportunity to contribute to the prevention and control efforts of an emerging pandemic,” reflected Roger Peck, a senior program officer working in PATH’s Diagnostics program.
The Washington COVID-19 Biorepository
PATH is now home to the Washington COVID-19 Biorepository. With support from the Bill & Melinda Gates Foundation, PATH is coordinating with clinical partners across Seattle to create a catalogue of inactivated virus and clinical samples, including nasal swabs, tongue swabs, nasopharyngeal swabs, serum, and plasma. These clinical samples include those collected from patients with a confirmed diagnosis of COVID-19 (all patient names and identifying information have been removed, of course).
Samples have come from the UnitedHealth Group via The Everett Clinic, the Washington State Public Health Laboratories, Fidalab, Bloodworks Northwest, the University of Washington Department of Global Health, and the University of Washington Department of Environmental & Occupational Health Sciences. PATH continues to expand this list, collaborating with the University of Washington to further access COVID-19 patient samples from two Seattle hospitals. PATH is also in the process of partnering with the University of Washington Department of Microbiology to prepare inactivated virus samples that are noninfectious and can be used in the early research and development of diagnostic tests.
The number of samples will continue to grow as more clinical partners collaborate and provide samples. Apart from overseeing this collection of specimens, PATH is applying its technical expertise to the assessment and development of COVID-19 diagnostics in a partnership with Global Good.
Samples for diagnostic assessment
The value of a diagnostic depends on how well it works and how confident we can be in the results. As companies and organizations develop and improve diagnostics for COVID-19, the biorepository will provide qualified, pedigreed sets of clinical samples to assist developers in the verification and validation of diagnostic tests.
“A standard pool of such samples provides an opportunity to compare tests and identify those best suited for use in a particular environment.”— Roger Peck, Senior Program Officer, Diagnostics
“A standard pool of such samples provides an opportunity to compare tests and identify those best suited for use in a particular environment,” explained Roger Peck. “We can also understand how tests might work together or help troubleshoot challenges we see as they are deployed in the health system.”
Using samples in the biorepository, PATH will provide third-party unbiased evaluations of promising diagnostic tests. PATH will support the qualification of tests already on the market and work with companies that have the capacity to produce effective tests at a global scale. PATH continues to work with investors and other stakeholders to understand and shape the economic and market forces that will allow these tests to reach communities quickly and cost-effectively.
Before the box arrived
Creating a biorepository is not as simple as collecting and storing samples. Weeks before the first samples arrived, work was underway on the logistic, legal, and ethical infrastructure required. PATH’s in-house expertise and existing assets—such as a Biosafety Level 2 laboratory, ethics review committee, and legal counsel—made the rapid creation of the biorepository possible.
Because of the unique and limited nature of these samples, a governance committee reviews submissions to help prioritize the use of these samples for tests that are intended for global markets and that can be manufactured at scale. This governance committee also guides the scientific, ethical, and legal use of the biorepository’s samples.