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.
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 at-home testing options.
Updates on at-home coronavirus test kits:
- On Apr. 21, the U.S. Food and Drug Administration (FDA) authorized the first COVID-19 diagnostic test with an option for home sample collection. The FDA issued the test under the emergency use authorization (EUA) for the LabCorp COVID-19 RT-PCR Test.
- On Jul. 24, the FDA issued a statement allowing the LabCorp test to be used in patients who do not have symptoms and to allow pooled sample testing. This change expands the use of the test to anyone, and the sample pooling (a pooled sample can contain up to five individual specimens) allows for fewer overall tests to be processed.
- As of Jul. 24, the FDA has authorized almost 200 tests (including diagnostic and antibody tests) under EUAs. Several diagnostic tests use a sample that you collect at home.
- A COVID-19 test costs $100-$155 without insurance. However, most insurance companies cover the cost of diagnostic testing when ordered by your physician.
- Through the duration of the public health emergency, all public and private insurance, including self-funded plans, must cover FDA-approved COVID-19 tests and costs associated with testing, with no cost-sharing. You can find out more details about your insurance plan and COVID-19 testing here, and what other services your policy offers during the pandemic, such as telehealth services.
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. The EUA allows unapproved medical products (or unapproved uses of already approved medical products) 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. The list is updated daily.
Compare COVID-19 at-home test kits
|Name of test||Company||FDA authorization||Availability||Collection method||Cost*||Insurance coverage|
|Pixel by LabCorp||LabCorp||Authorized under the FDA EUA||Request online. The kit is shipped to your house by FedEx. Test not available in NY||Nasal swab (video instructions provided)||No upfront cost||LabCorp will bill insurance or use federal funds|
|EverlyWell COVID-19 Test Home Collection Kit||Everlywell, Inc.||Authorized under the FDA EUA||Patients must be 18 years or older. Test not permitted in New Jersey, New York, RI, or MD.||Nasal swab||$109||Download receipt and submit for reimbursement|
|Vault||Vault Health, Spectrum Solutions, RUCDR Infinite Biologics||Authorized under the FDA EUA||Order test online must be 18 years or older. Test not available in Alaska.||A saliva sample is collected during telehealth appointment with medical professional||$150||Pay out-of-pocket; submit for reimbursement|
|Vitagene||Vitagene||Authorized under the FDA EUA||Take an assessment to see if you qualify for a diagnostic test. If you are eligible, the test will be shipped to you.||Saliva sample||Price not provided||Pay out-of-pocket and submit for reimbursement|
|LetsGetChecked||PrivaPath Diagnostics||Authorized under the FDA EUA||Complete an online assessment. If you qualify, a kit will be sent to you.||Nasal swab||$119||Pay out-of-pocket and submit for reimbursement|
|Picture||Fulgent Genetics||Authorized under the FDA EUA||Complete an online assessment. If you qualify, a kit will be sent to you.||Nasal swab||$119||Pay out-of-pocket and submit for reimbursement|
|Phosphorous||Phosphorous Diagnostics||Authorized under the FDA EUA||Complete an online assessment. If you qualify, a kit will be sent to you.||Saliva collection||$155 ($140 + $15 shipping)||Pay out-of-pocket and submit for reimbursement|
* Cost of coronavirus test kits can vary. Check the websites for accurate pricing.
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 home 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-quarantine until you receive your results.
How accurate are at-home coronavirus tests?
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.
On May 14, the FDA issued a statement regarding the Abbott ID NOW point-of-care test. The report informed the public that false-negative results might occur with this test. The FDA is working with Abbott to continue evaluating accuracy issues. In the statement, 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.”
Other companies make general statements about their accuracy. For example, on the Pixel by LabCorp website: “Your samples are tested in a CAP-accredited and CLIA-certified LabCorp lab, meeting the highest standards of accuracy and timeliness of test results.”
The Vault Health website states that 98% of results will return as positive or negative, but 2% of results will be inconclusive.
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.
How to get at-home COVID-19 tests
How do you get access to a coronavirus test at home? It depends on which company you use. Most companies (see chart below) require that you fill out an online questionnaire and have a telehealth consultation. Then, they will ship you a test kit in the mail. After you collect the sample, you’ll send it back to the company with a prepaid label and receive your results in several days. Your local pharmacy may sell home test kits as well.
Cost and insurance coverage
If you can get a test at your in-network healthcare provider’s office, the Families First Coronavirus Response Act (FFCRA) will likely cover it. 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. 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.