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CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news, and information changes. For the latest on the COVID-19 pandemic, please visit the Centers for Disease Control and Prevention.
FDA authorization | Compare home COVID test kits | How it works | Accuracy | Availability | Cost & insurance coverage | Other testing methods
If you think you’ve been exposed to the novel coronavirus disease or are experiencing symptoms of COVID-19, the first step is to get tested. When the pandemic first started spreading across the U.S., tests were difficult to come by. Now, there is easier access to testing, less invasive tests, and quicker results. There are even rapid, at-home COVID tests.
Which coronavirus home test kits are authorized by the FDA?
The testing kits currently available are authorized under the FDA’s EUA, or emergency use authorization program. An EUA allows for use of medical products (or unapproved uses of already approved medical products) which have not yet gained full FDA approval to be used in an emergency for the diagnosis, treatment, or prevention of life-threatening diseases or conditions when there are no adequate, accepted, and available alternatives.
The FDA website lists all of the COVID-19 tests approved under the EUA.
Compare COVID-19 at-home test kits |
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|---|---|---|---|
| Name of test | Company | Availability | Collection method |
| BinaxNOW COVID-19 Ag Card Home Test | Abbott Diagnostics Scarborough, Inc. | Available patients 15 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab (requires instruction by a telehealth proctor) |
| BinaxNOW COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | Available patients 15 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| CareStart COVID-19 Antigen Home Test | Access Bio, Inc. | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| BD Veritor At-Home COVID-19 Test | Becton, Dickinson and Company (BD) | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab; requires a smartphone |
| Celltrion DiaTrust COVID-19 Ag Home Test | Celltrion USA, Inc | Available patients 14 years or older =within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Mid-turbinate nasal swab |
| Cue COVID-19 Test for Home and Over The Counter (OTC) Use | Cue Health Inc. | Available patients 18 years or older (or 2 years and older when collected by an adult) with or without symptoms | Nasal swab; requires a Cue Cartridge (sold separately) and a smartphone |
| Detect Covid-19 Test | Detect, Inc. | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab; requires a Detect Hub (sold separately) and a smartphone |
| Ellume COVID-19 Home Test | Ellume | Available patients 16 years or older (or 2 years and older when collected by an adult) with or without symptoms | Mid-turbinate nasal swab; requires a smartphone |
| iHealth COVID-19 Antigen Rapid Test | iHealth Labs, Inc. | Available patients 15 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| SCoV-2 Ag Detect Rapid Self-Test | InBios International Inc | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| Lucira CHECK-IT COVID-19 Test Kit | Lucira Health, Inc | Available patients 14 years or older (or 2 years and older when collected by an adult) with or without symptoms | Nasal swab |
| MaximBio ClearDetect COVID-19 Antigen Home Test | Maxim Biomedical, Inc. | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 5 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| InteliSwab COVID-19 Rapid Test | OraSure Technologies, Inc. | Available patients 18 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| QuickVue At-Home OTC COVID-19 Test | Quidel Corporation | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 6 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| Pilot COVID-19 At-Home Test | SD Biosensor, Inc. | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 6 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
| CLINITEST Rapid COVID-19 Antigen Self-Test | Siemens Healthineer | Available patients 14 years or older (or 2 years and older when collected by an adult) within the first 7 days of symptom onset. Without symptoms, serial test twice over 3 days. | Nasal swab |
How do home COVID-19 tests work?
Typical means of self-collection for diagnostic home testing include nasal swab or saliva collection. Many times, an instructional video is provided with the in-home COVID test kit, or a telehealth appointment may be required, where a healthcare provider will walk you through the specimen collection process to ensure that you are correctly collecting a sample.
Once you receive the results, you can consult your healthcare provider about further steps, such as quarantine and treatment. However, if you are testing because you believe you are positive for COVID, you should self-isolate until you receive your results.
Are COVID-19 self-tests reliable?
The FDA outlined policies for test accuracy in this guidance statement. Because of the potential health threat, the FDA must ensure that testing is widely available and that the testing is accurate and reliable.
The FDA stated, “no diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly.”
While most tests will return an accurate result, if you receive a negative result but are experiencing symptoms of COVID-19, you should contact your healthcare provider about retesting and further steps.
RELATED: Do home COVID tests expire?
Where to buy COVID home tests
At-home COVID-19 tests are widely available. You can order them online, or pick them up at your local drug store. The tests outlined allow for your results to be received at home after a 10 to 30 minute waiting period (exact time is dependent on the specific test, therefore follow the instructions provided with your test before determining your result). (The U.S. government is offering four free at-home COVID test kits to all households. Free tests are also available through local health departments.
How much does a COVID-19 test cost?
If you can get tested at your in-network doctor’s office, the COVID-19 testing will likely be covered under the Families First Coronavirus Response Act (FFCRA). However, if you opt for a home test kit, pricing and insurance coverage will vary. Some companies work with private insurance, Medicare, or federal funds, while others may have you pay out-of-pocket, and then you can print a receipt that you can submit to your insurance for reimbursement. Also, you can use your HSA card to pay for many home kits. The cost of home kits ranges from $0 to approximately $155.
Although insurance companies provide COVID-19 testing at no charge, they may have certain restrictions, such as a healthcare professional must order the test, or you must have symptoms or be a healthcare worker or first responder to require a test. Check with your insurance provider for details of your plan.
Other types of coronavirus testing
All at-home coronavirus tests are diagnostic tests, which look for active viral infection with SARS-CoV-2. If these at-home testing doesn’t work for you, contact your healthcare provider for more information on testing and testing sites near you. Your local pharmacy may provide testing. There are other sources of COVID-19 testing available such as mobile clinics and urgent care clinics.
In addition to diagnostic testing, there are also antibody tests to determine exposure to COVID-19. At-home antibody tests are still in development. The FDA recently issued a statement after issuing warning letters to companies who marketed unapproved antibody tests: “There are not any serology tests that are authorized for use with at-home collection of samples.” More information about antibody testing can be found here.