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.
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.: | 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.: | 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.: | 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: | 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): | 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.: | 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.: | 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.: | 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: | 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.: | 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: | 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: | 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.: | 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.: | 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: | 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.: | 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: | 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
