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Coronavirus: FDA releases updated list of authorized at home COVID-19 tests

The U.S. Food and Drug Administration released on Tuesday an updated list of FDA-authorized at-home over-the-counter (OTC) COVID-19 tests.

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An at-home COVID-19 diagnostic test is one where you collect your own sample, perform the test and read the results yourself. The test does not require you to send a sample to a laboratory. Most tests will use a nasal swab for the testing.

The updated list contains 17 test kits, which are either antigen or molecular tests. An antigen test detects specific proteins from the virus while a molecular test detects the genetic material from the virus.

Authorized at-home OTC tests are available without a prescription and are typically available online or at local retailers.

The table below lists the FDA-authorized at-home OTC COVID-19 diagnostic tests:

Manufacturer
and Test Name
Test TypeSymptomsAgeOther 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 14 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

A positive self-test result means that the test detected the virus, and you are very likely to be infected and should stay home or isolate, wear a mask if you have contact with others, and avoid indoor gatherings to reduce the risk of spreading disease to someone else.

A negative self-test result means that the test did not detect the virus and you may not have an infection, but it does not rule out infection. Repeating the test within a few days, with at least 24 hours between tests, will increase the confidence that you are not infected.

Last month, the federal government began sending out COVID-19 tests to American households that want them.

The free tests can be ordered online and will usually ship within 7-12 days of ordering.

No identification, credit card or health insurance information is required — you just need to include your name and a street address.

If you want to track your request for the tests, you can add an email address to get updates on your tests.


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