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The Coordination and Data Collection Center (CDCC) Testing Core provides expert review of projects, technical support with test methods, guidance on FDA regulatory issues, guidance with scientific and study design, and procurement support as needed. They also advise about emerging or existing testing technologies. Watch this short video about the testing core to learn more, and explore our resources below.
Download the guide to RADx-UP testing requirements for projects.
Explore a list of authorized RADx testing vendors, organized by type of test.
The Testing Core has compiled several quick reference guides on COVID-19 point of care (POC), home/self-collect, and antibody testing options. Please note: projects must execute testing exactly as stated in the FDA authorization letter and IFU. Additionally, these reference guides are not exhaustive and are current as of the date posted. For a complete list of assays, please visit the FDA In Vitro Diagnostics EUAs page.
For more information on POC testing options, download this quick reference guide.
For more information about antibody testing, download this quick reference guide.*
For more information about saliva testing, download this quick reference guide.
For information about at-Home Specimen Collection or At-Home Self-collection and Self-testing, download this quick reference guide.**
*For assistance with antibody test selection for project team’s community, check out this calculator from the FDA as well as this immune response blog.
When designing protocols around antibody testing, project teams should consider the potential impact on seroprevalence due to immunity from vaccination. Given that current vaccines target the spike (S) protein, testing platforms that only detect antibody against the S protein may not reliably discriminate between immune response from natural infection and vaccination. As a result, projects may need to identify an algorithm for further differentiation, use platforms with additional targets, or identify an alternative testing strategy. The CDCC Testing Core is happy to provide guidance for projects, as needed.
**Only FDA EUA assays with specific product labeling for home use are allowable. Please refer to this quick reference guide, which includes a list of potential vendors that have received FDA EUA for (1) unsupervised at home specimen collection and ship and (2) at home specimen collection
