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  1. Coronavirus (COVID-19) and Medical Devices

At-Home OTC COVID-19 Diagnostic Tests

 

A woman performing a nose swab on herself as part of a COVID at home test.

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This page provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests.  

These at-home COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations).  This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. Authorized at-home OTC tests are available without a prescription and are typically available online or at local retailers.

Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19 infection.

List of Authorized At-Home OTC COVID-19 Diagnostic Tests 

This table lists FDA-authorized at-home OTC COVID-19 diagnostic tests. This table includes links to home use instructions for each test. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.

Manufacturer and Test Name (Links to Instructions for Use) Test Type Who can use this test: Symptoms Who can use this test: Age Other Details
Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Ag Card Home Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Requires supervision of a telehealth proctor and a smartphone or computer
  • Results in 15 minutes
Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Results in 15 minutes
Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/go COVID-19 Antigen Self-Test
  • Results in 10 minutes
ACON Laboratories, Inc:
Flowflex COVID-19 Antigen Home Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Alternate brand name: On/Go One COVID-19 Antigen Home Test
  • Results in 15 minutes
Becton, Dickinson and Company (BD):
BD Veritor At-Home COVID-19 Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Requires a smartphone
  • Results in 15 minutes
Celltrion USA, Inc.:
Celltrion DiaTrust COVID-19 Ag Home Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Mid-turbinate nasal swab
  • Smartphone optional
  • Results in 15 minutes
Cue Health Inc.:
Cue COVID-19 Test for Home and Over The Counter (OTC) Use
Molecular
  • People with or without symptoms
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Requires a Cue Cartridge Reader (sold separately)
  • Requires a smartphone
  • Results in 20 minutes
Detect, Inc.:
Detect Covid-19 Test
Molecular
  • People suspected of COVID-19
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Requires a Detect Hub (sold separately)
  • Requires a smartphone
  • Results in 60 minutes
Ellume Limited:
Ellume COVID-19 Home Test
Antigen
  • People with or without symptoms
  • Age 16 years and older
  • Age 2 years and older when collected by an adult
  • Mid-turbinate nasal swab
  • Requires a Smartphone
  • Results in 15 minutes
iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 15 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Results in 15 minutes
InBios International Inc:
SCoV-2 Ag Detect Rapid Self-Test
Antigen
  • People with symptoms that began within the last 5 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Results in 20 minutes
Lucira Health, Inc:
Lucira CHECK-IT COVID-19 Test Kit
Molecular
  • People with or without symptoms
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes
Maxim Biomedical, Inc.:
MaximBio ClearDetect COVID-19 Antigen Home Test
Antigen
  • People with symptoms that began within the last 5 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Results in 15 minutes
OraSure Technologies, Inc.:
InteliSwab COVID-19 Rapid Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 18 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Smartphone optional
  • Results in 30 minutes
Quidel Corporation:
QuickVue At-Home OTC COVID-19 Test
Antigen
  • People with symptoms that began within the last 6 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Results in 10 minutes
SD Biosensor, Inc.:
COVID-19 At-Home Test
Antigen
  • People with symptoms that began within the last 6 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Results in 20 minutes
Siemens Healthineer:
CLINITEST Rapid COVID-19 Antigen Self-Test
Antigen
  • People with symptoms that began within the last 7 days
  • People without symptoms. The test is to be performed two times over three days (serial testing)
  • Age 14 years and older
  • Age 2 years and older when collected by an adult
  • Nasal swab
  • Results in 15 minutes

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