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COVID-19 Diagnostics Benchmarking Panel

By Diagnostics

Use of the COVID-19 Diagnostics Benchmarking Panel can support evaluation of COVID-19 antigen-detection diagnostic tests at any stage of the product lifecycle

Testing is central to efforts to control the COVID-19 pandemic. With over 1000+ tests currently in development or in the market, understanding test quality, performance, and availability is key to response efforts. Yet, current understanding of product performance is limited by lack of data, deviations in study design, and variation in clinical specimens.

With high demand and global focus on testing, there is a growing need for improved evaluation of diagnostics to inform development, selection, procurement, and deployment decisions.

To address this need, PATH is producing a COVID-19 diagnostic benchmarking panel that offers objective analytical performance data for COVID-19 antigen tests, providing a standardized, unbiased, and comparative evaluation tool. The COVID-19 diagnostic benchmarking panel will improve the quality of assessment for test developers while also supporting product selection and procurement decision-making to enable evidence-driven pandemic response strategies.

Click here to express your interest in obtaining a COVID-19 Diagnostic Benchmarking Panel.

Please be aware that this product is in late development and that submitting your interest does not guarantee access to the panels.

Composition

The COVID-19 Diagnostic Benchmarking Panel is composed of several members including panel diluent controls, a range of concentrations of inactivated SARS-CoV-2 virus and recombinant SARS-CoV-2 N protein antigens, SARS-CoV-2-negative nasal eluate, and other human common coronaviruses. The panel does not include SARS-CoV-2-positive clinical specimens[SB3] .

Use

Once available, the panels can be used at the point of manufacture (currently US domestic use only, international use coming soon) or in-house at PATH (Seattle, Washington). If used at the point of manufacture, then the blinded panel will be shipped with detailed instructed for use. The user will run the panel against the specified RDT and share data back with PATH for analysis. PATH will then unblind the panel and share performance results analysis with the user.

For access to clinical specimens or to learn more about PATH’s full benchmarking activities please contact SpecimenRepository@path.org.

The Bill & Melinda Gates Foundation provided funding to support development and feasibility of the COVID-19 Diagnostics Benchmarking Panel.

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