SARS-CoV-2 Nucleocapsid Protein Panel
Use of the SARS-CoV-2 Nucleocapsid Protein Panels with rapid diagnostic tests can support benchmarking of antigen-detection diagnostic tests at any stage of the product life cycle
While studies are underway to evaluate the clinical performance of SARS-CoV-2 rapid diagnostic tests (RDTs), comparison of results across studies can be complicated by differences in study designs, recruitment strategies, prevalence within the populations, and user-product interactions. To address these challenges, PATH is producing uniform panels for nucleocapsid antigen RDTs that will improve the quality of assessment for test developers and offer a degree of comparability of diagnostic tests for a variety of stakeholders.
Utilizing a panel of standardized and uniform reagents enables comparability of analytical performance data across SARS-CoV-2 antigen RDTs, thus providing a benchmark. The SARS-CoV-2 Nucleocapsid Protein Panel provides an essential tool for developers to rapidly assess and verify basic performance characteristics of their technologies. The panels can also be leveraged by ministries of health and donors who are interested in evaluating technologies to support procurement decision-making.
Click here to express your interest in obtaining the SARS-CoV-2 Nucleocapsid Protein Panel. Please be aware that this product is in late development and that submitting your interest does not guarantee access to the panels.
The SARS-CoV-2 Nucleocapsid Protein Panel is composed of 50 members containing panel diluent controls and a range of concentrations of irradiated (inactivated) SARS-CoV-2 virus, recombinant N antigens, and SARS-CoV-2-negative nasal eluate and other human common coronaviruses (not inactivated). The panel does not include SARS-CoV-2-positive clinical specimens.
Once available, the panels can be shipped to manufacturers blinded, or, if preferred, manufacturers can provide their RDTs to PATH to conduct the benchmarking tests at its facilities in Seattle, Washington, USA. Detailed instructions for use will be provided with the panels.
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 SARS-CoV-2 Nucleocapsid Protein Panel.