The list below includes lab, point-of-care, and over-the-counter/at-home tests and test products with emergency use authorization (EUA) or traditional marketing authorization from the U.S. Food and Drug Administration (FDA). The organization name and link to the authorization letter from the FDA are provided.
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.
- A 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.
Tests with FDA Traditional Marketing Authorization
Healgen Rapid Check COVID-19/Flu A&B Antigen Test - Over the counter (OTC)*
*Authorization supported through the RADx® Independent Test Assessment Program (ITAP)
Over-the-counter Tests - Antigen - Multiplex
*EUA supported through the RADx® Independent Test Assessment Program (ITAP)
Point-of-care Tests - Antigen - Multiplex
*EUA supported through the RADx® Independent Test Assessment Program (ITAP)
Point-of-care tests - Molecular - Multiplex
*EUA supported through the RADx® Independent Test Assessment Program (ITAP)
Over-the-Counter Tests - Antigen
Azure Biotech, Inc. Antigen Pen Home Test*
Quidel: QuickVue At-Home (screening)
SD Biosensor distributed by Roche*
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.