COVID-19 Testing Tips for RADx-UP Projects

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 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, read our FAQ here, and explore our resources below.

RADx-UP projects are required to use FDA-authorized tests. To learn more about this, read the requirements guide to the right. RADx-UP Projects can use any vendor, as long as the assay is authorized by the FDA.

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, antibody, and saliva testing options. Please note: projects must execute testing exactly as stated in the FDA authorization letter and Instructions for Use (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.

RADx-UP Project Testing Requirement Guide

Learn more about the COVID-19 requirements for RADx-UP projects.

RADx Vendors

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

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At-Home Testing

For information about at-home specimen collection or at-home self-collection and self-testing, download this quick reference guide.*

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Point of Care Testing

For more information on Point of Care (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.**

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Saliva Testing

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

*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 and self-test.
**For assistance with antibody test selection for project team's community, refer to this resource from the CDC, as well as this immune response blog from Arizona State University.

Alerts, Recalls, and Updates

For a full list of medical device recalls for 2023, please visit the FDA website here.

Oct. 3, 2023 | FDA At-Home OTC COVID-19 Diagnostic Tests
The FDA regularly updates guidance on extended shelf-life and updated expiration dates for At-Home over-the-counter (OTC) COVID-19 Diagnostic Tests. It is important to continue adherence to repeat testing based on the step-by-step guidance, including how to anonymously report OTC at-home COVID-19 test results to MakeMyTestCount.org.

Sept. 25, 2023 | Four free COVID-19 tests available for US households
Every US household can again place an order to receive four free COVID-19 rapid tests delivered directly to their home. Visit covid.gov/tests to place an order.

Feb. 7, 2023 | MakeMyTestCount.org
The FDA updated its step-by-step guide to include anonymous reporting of over-the-counter (OTC) at-home COVID-19 test results to MakeMyTestCount.org. The data from MakeMyTestCount.org can help public health departments know how fast the virus is spreading. Read the notification from FDA and visit MakeMyTestCount.org to learn more.

Jan. 24, 2023 | CDC Free COVID-19 Test Locator
On Jan. 24, 2023, CDC launched a website to help consumers find free COVID-19 testing sites. The locator is part of the CDC Increasing Community Access to Testing (ICATT) program, which provides access to COVID-19 testing, focusing on communities at a greater risk of being impacted by the pandemic, people who do not have health insurance, and surge testing in state and local jurisdictions. Read the notification from CDC and visit the testing locator website to learn more.

Nov. 1, 2022 | EUA Revision for Serial (Repeat) Testing and Product Labeling
On November 1, 2022, the FDA updated the EUA revision for Serial (Repeat) Testing and required updates to product labeling for all currently authorized SARS-CoV-2 antigen tests. Learn more about how this impacts RADx-UP projects in the November issue of the RADx-UP CDCC newsletter.
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Aug. 11, 2022 | At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
The FDA recommends repeat antigen testing following a negative result whether or not you have COVID-19 symptoms, beyond what is stated in kit instructions and consider molecular (lab based) testing if in doubt.
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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.
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Nov. 11, 2021 | Testing Core Guidance
Guidance from the RADx-UP CDCC Testing Core on false positives and false negatives.
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Nov. 11, 2021 | FDA Ellume Recall
FDA announces a Class I recall of certain Ellume at-home tests.
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Oct. 25, 2021 | Ellume Recall
Digital diagnostics company Ellume today announced it is voluntarily recalling specific lots of the Ellume COVID-19 Home Test.
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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.
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Aug. 17, 2021 | Potential of False Results: Curative
Risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.
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Aug. 17, 2021 | Potential of False Results: Thermo
Risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit
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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.
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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.
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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.
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FDA resource on SARS-CoV-2 viral mutations

Explore a full list of SARS-CoV-2 viral mutations’ impact on COVID-19 tests, including information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.

Grants

Upcoming opportunities to apply for funding.

Resources

Explore our library of resources for researchers and the general public.

Publications

Explore our dashboard of recent RADx-UP scholarship.