COVID-19 Testing Tips for

RADx-UP Projects

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.

Testing Requirements Guide

Download the guide to RADx-UP testing requirements for projects.

RADx Vendors

Explore a list of authorized RADx testing vendors, organized by type of test.

COVID-19 TESTING QUICK REFERENCE GUIDES

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.

Point of Care Testing

For more information on POC testing options, download this quick reference guide.

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Antibody Testing

For more information about antibody testing, download this quick reference guide.*

Download

Saliva Testing

For more information about saliva testing, download this quick reference guide.

Download

At-Home Testing

For information about at-Home Specimen Collection or At-Home Self-collection and Self-testing, download this quick reference guide.**

Download

*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

ALERTS & RECALLS

Dec. 12, 2021 | SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

With SARS-CoV-2, variants will continue to emerge and questions will arise on whether or not test performance is impacted by these variants. For updated information, please refer to the FDA website.

Nov. 11, 2021 | Testing Core Guidance

Guidance from the RADx-UP CDCC Testing Core on false posistives and false negatives.

Nov. 11, 2021 | FDA Ellume Recall

FDA announces a Class I recall of certain Ellume at-home tests.

Oct. 25, 2021 | Ellume Recall

Digital diagnostics company Ellume today announced it is voluntarily recalling specific lots of the Ellume COVID-19 Home Test.

Oct. 15, 2021 | Abbott Alinity Recall

FDA announces a Class I recall of software in use for in the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit.

Aug. 17, 2021 | Potential of False Results: Curative

Risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test

Aug. 17, 2021 | Potential of False Results: Thermo

Risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit

July 29, 2021 | Potential of False Results: BD Max

Increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

March 21, 2021 | Required Serial Testing for At Home Tests

FDA authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening.

March 12, 2021 | Potential of False Results: Roche

False positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test.