Help Inform Research Strategy for Coronavirus Serology Testing

Funding News Edition: May 20, 2020
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The National Cancer Institute (NCI) will lead NIH efforts to develop, validate, improve, and implement serological testing and associated technologies. Robust serologic testing is key to our understanding population-wide viral pathogenicity, developing and testing SARS-CoV-2 vaccines, and understanding antibody production and immunity.

Through the Request for Information (RFI): Strategy for Research in Coronavirus Serology Testing and Serological Sciences, NCI is soliciting community feedback on two research topics related to serology:

  1. Research about the relationship between immunity, recent infection, antibody production, and other immunological markers
    • The role and value of animal models and in vitro assays for determining the relationship between antibody production and immunity to SARS-CoV-2
    • The types and titers of antibodies that are important for immune protection and the mechanism of such protection
    • Whether cross-reacting antibodies from prior infection by other coronaviruses confer immunity
    • Whether antibodies to coronaviridae can cause immunopathogenesis (e.g., ADE)
    • Genetic or other host factors that could predict antibody production and innate or adaptive immunity
    • Specific virologic factors that mediate the generation of effective host immunity, especially humoral immunity vs. cell-mediated immunity
  2. Clinical utilization of serological testing
    • Design strategies for use in clinical trials and population-based observational studies that are optimal to address the most critical research questions, including biospecimen sampling/biobanking considerations as well as safety and ethical considerations
    • Characteristics and performance standards needed for serological testing, whether for seroprevalence surveys or point-of-care tests
    • Approaches to rapidly increase capacity for high-quality serology testing in the United States, by leveraging existing infrastructure, especially for underserved communities
    • How to use and interpret serological testing results safely, effectively, and equitably

The RFI invites your comments on research approaches for these topics; innovative strategies to advance research progress; the challenges to progress in these areas; emerging trends, advances, technologies, analytic strategies, and perspectives that NCI should consider; potential approaches to gauge research progress and success; and any related topics you consider relevant.

To send feedback, email Indicate “RFI Response” in the subject line of your email and include a reference to NOT-CA-20-065.

The deadline to respond is May 26, 2020, at 11:59 p.m. Eastern Time.

Responses are voluntary and may be submitted anonymously. Take care not to share any personally identifiable, proprietary, classified, confidential, or sensitive information.

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