Clinical specimen bank now includes convalescent plasma, creating more opportunity for affordable diagnostic development
Seattle – September 29, 2020 – Recently expanded to support diagnostics developers earlier in the development cycle, the Washington COVID-19 biorepository now includes convalescent plasma to accelerate the development of antibody assays.
The current pandemic showcases a critical need to accelerate the development and validation of quality diagnostic products for COVID-19. To support this effort, PATH, a global health non-profit, has created a growing biorepository of qualified clinical samples to support and accelerate the development and validation of quality in-vitro diagnostics.
Convalescent plasma samples allow manufacturers to assess the performance of several designs and prototypes under development. By running multiple replicates of these relatively accessible specimens on each prototype, diagnostics 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 specimens from longitudinal cohorts drawn 1, 2, 4, 8, and 12 weeks post diagnosis to validate final performance.
With support from the Bill & Melinda Gates Foundation, PATH has been coordinating with clinical partners across the Seattle area since the beginning of the pandemic to create a catalogue of inactivated virus and clinical samples, including nasal swabs, tongue swabs, nasopharyngeal swabs, serum, and now convalescent plasma to assist developers in the verification and validation of diagnostic tests. These clinical samples include those collected from patients with a confirmed diagnosis of COVID-19 using an FDA EUA COVID-19 RT PCR diagnostic test.
“The value of a diagnostic depends on how well it works and how confident we can be in the results. A standard pool of qualified, pedigreed sets of clinical samples provides an opportunity to compare tests and identify those best suited for use in a particular environment,” explained Roger Peck, Senior Program Officer for PATH Diagnostics. “We can also understand how tests might work together or help troubleshoot challenges we see as they are deployed in the health system.”
Due to the unique and limited nature of these samples, a governance committee will review all submissions to help prioritize the use of free clinical 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.
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