COVID-19 Diagnostics Benchmarking Panel
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 control the COVID-19 pandemic. With over 1,000 tests currently in development or on the market, understanding test quality, performance, and availability is key to response efforts. Yet, current understanding of product performance is limited by a lack of data, deviations in study design, and variations 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.
PATH produced 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 submitting your interest does not guarantee access to the panels.
Composition
The COVID-19 Diagnostic Benchmarking Panel comprises 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
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 instructions for use. The user will run the panel against the specified RDT and share data 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 the development and feasibility of the COVID-19 Diagnostics Benchmarking Panel.
