Authorized Tests for COVID-19 and Multiplex Diagnostics

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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), 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. 

  • A multiplex test may be an antigen or molecular test that detects more than one virus such SARS-CoV-2 and influenza.

 

Over-the-Counter Tests - Antigen

Over-the-counter Tests - Antigen - Multiplex

Point-of-care tests - Molecular - Multiplex

Lab Tests - Antigen

Ellume

 

Test Products

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