Seattle – September 29, 2020 – Recently expanded to support diagnostic developers earlier in the development cycle, the Washington COVID-19 biological repository now includes convalescent plasma to accelerate the development of antibody testing.
The current pandemic demonstrates a critical need to accelerate the development and validation of diagnostic products for COVID-19. To support this effort, PATH, a global health nonprofit, has created a growing repository of qualified clinical specimens to support and accelerate the development and validation of quality in vitro diagnostics.
Convalescent plasma samples allow manufacturers to evaluate the performance of several designs and prototypes in development. By performing multiple replicas of these relatively available samples on each prototype, diagnostic developers can generate large amounts of performance data allowing for better assessment of the technology. Once proven, developers can then use scarce serum and plasma samples from longitudinal cohorts drawn 1, 2, 4, 8, and 12 weeks after diagnosis to confirm final performance.
With support from the Bill & Melinda Gates Foundation, PATH has coordinated with clinical partners across the Seattle area since the pandemic to create a catalog of inactivated viruses and clinical specimens, including nasal swabs, tongue swabs, nasopharyngeal swabs, serums, and now convalescent plasmas to help developers check. and validation of diagnostic tests. These clinical specimens include specimens collected from patients with a confirmed diagnosis of COVID-19 using the FDA EUA COVID-19 RT diagnostic test.
“The value of diagnostics depends on how well it works and how confident we can be in the results. A standard set of qualified, pedigree packages of clinical specimens provides an opportunity to compare tests and determine those most suitable for use in a particular environment,” explained Roger Peck, senior programmer. PATH diagnostics officer. “We can also understand how tests can work together or help address the challenges we see as they are deployed in the health system.”
Due to the unique and limited nature of these samples, the Steering Committee will review all applications to help prioritize the use of free clinical samples for tests that are targeted at global markets and can be produced to a large extent. This Steering Committee also guides the scientific, ethical and legal use of biological storage samples.
Diagnostic developers can click here to inquire about access to Washington’s COVID-19 biorepository or email firstname.lastname@example.org for more information.
PATH is a global organization working to stop health inequalities by bringing together public institutions, businesses, social enterprises and investors to address the world’s most pressing health challenges. With expertise in science, healthcare, economics, technology, advocacy and dozens of other specialties, PATH develops and scales solutions – including vaccines, drugs, devices, diagnostics and innovative approaches to strengthening health systems around the world. Learn more at http://www.path.org.
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