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.
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 Type | Symptoms | 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 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.
More coronavirus pandemic coverage:
>> Coronavirus: How long between exposure to the virus and the start of symptoms?
>> How to not let coronavirus pandemic fatigue set in, battle back if it does
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