Authorized Tests for COVID-19 Diagnostics

The list below includes lab, point-of-care, and over-the-counter/at-home tests and test products with emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The organization name and link to the authorization letter from the FDA are provided. Only active RADx® Tech projects are listed. 

Authorized tests are organized by the type of test (molecular or antigen) and use setting.

  • An antigen test, frequently used for rapid testing, detects viral proteins found in SARS-CoV-2. Results are usually available in 30 minutes or less. Most over-the-counter COVID-19 tests are antigen tests.  

  • molecular test detects the genetic material of SARS-CoV-2. This test is usually conducted at the point-of-care or a sample is collected and sent to a lab for processing. Delivery of results can range from 30 minutes to several days depending on sample processing. 

 

Over-the-Counter Tests - Antigen

ANP Technologies, Inc.

Azure Biotech, Inc.*

Becton, Dickinson and Company

Ellume USA, LLC

Maxim Biomedical*

OSANG, LLC*

Quidel: QuickVue At-Home (screening)

Quidel: QuickVue At-Home

SD Biosensor distributed by Roche*

Siemens*

Watmind USA*

Xiamen Boson Biotech Co., Ltd.*

*EUA supported through the RADx® Independent Test Assessment Program (ITAP) 

Refer to this FDA information about how to use and store at-home COVID-19 tests properly. 

Refer to this FDA information about extended expiration dates for at-home COVID-19 tests.

 

Over-the-Counter Tests - Molecular

Detect

 

Point-of-Care Multiplex Tests - Molecular

Lucira Health, Inc.*

*EUA supported through the RADx® Independent Test Assessment Program (ITAP) 

 

Lab Tests - Antigen

Test Products

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