The questions everyone wants to know: can you get a COVID-19 home test kit? And do they work?
The good news is that researchers have been working furiously to improve the accuracy, cost, and convenience of testing. While COVID-19 tests are available at many medical sites, people now also have the option of ordering test kits online and self-collecting their specimens.
The table below shows every COVID-19 test that has been authorized by the FDA for home testing, as of this writing. Read on to learn more about how Coronavirus home test kits work, the accuracy of home tests, and how to order home test kits online.
Coronavirus Diagnostic (Active Virus) Home Test Kits
|Test Name||Manufacturer||Type of Test||Time to Results||Cost|
|Assurance SARS-CoV-2 Panel||Assurance Scientific Laboratories||Nasal swab||24-48 hours||$150|
|Color COVID-19 Self-Swab Collection Kit||Color Genomics, Inc.||Nasal swab||24-72 hours||N/A|
|Compass Laboratory Services SARS-CoV-2 Assay||Compass Laboratory Services, LLC||Nasal swab||24-48 hours||N/A|
|CRL Rapid Response COVID-19 Saliva Test||Clinical Reference Laboratory, Inc.||Saliva||48 hours||$195|
|DxTerity SARS-CoV-2 RT-PCR CE Test||DxTerity Diagnostics, Inc.||Saliva||48 hours||$125|
|EverlyWell COVID-19 Test Home Collection Kit**||EverlyWell, Inc.||Nasal swab||24-48 hours||$109|
|Hims and Hers*||RUCDR, Rutgers University||Saliva||3-5 days||$150|
|KPMAS COVID-19 Test||Kaiser Permanente Mid-Atlantic States||Real-time RT-PCR, Home Collection, Screening||N/A||Free to members|
|Kroger Health COVID-19 Test Home Collection Kit||Gravity Diagnostics, LLC||Nasal swab||72 hours||N/A|
|LetsGetChecked||PrivaPath Diagnostics, Inc.||Nasal swab||24 to 72 hours||$119|
|MicroGenDx Rapid PCR Test||MicroGen Diagnostics||Saliva||24-48 hours||$99 plus shipping|
|P23 At-home Collection Kit||P23 Labs, LLC||Saliva||24-48 hours||$109|
|Phosphorus COVID-19 RT-qPCR Test||Phosphorus Diagnostics LLC||Saliva||72 hours||$140|
|Picture Genetics||Fulgent Therapeutics, LLC||Nasal swab||72 hours||$119|
|Pixel||Laboratory Corporation of America (LabCorp)||Nasal swab||4-48 hours||$0 upfront|
|Quest Diagnostics Self-Collection Kit for COVID-19||Quest Diagnostics Infectious Disease, Inc.||N/A||24-48 hours||$119|
|Vault Health||RUCDR, Rutgers University||Saliva||24-48 hours||$150|
|Vitagene||RUCDR, Rutgers University||Saliva||Within 72 hours||$129|
*Availability varies by state **Not available in New York, New Jersey, or Rhode Island
Are COVID-19 Home Tests FDA-approved?
They are FDA-authorized, but not FDA-approved. At the time of this writing, there are no approved home diagnostic tests. Every test listed in the table above has received emergency use authorization (EUA) from the FDA. This certification means that the tests have not gone through full FDA investigation (though they have met preliminary standards of safety and efficacy), but their benefit is greater than their risk in light of the Coronavirus public health emergency.
Who Should Be Tested?
Anyone who has COVID-19 symptoms, has been exposed to someone who has the virus, or has been in a high-risk situation should call their medical provider. Some people choose to use the CDC Self-checker to help them decide if they should contact their medical provider to ask about testing.
Who Can Order a COVID-19 Home Test?
All testing services require a referral from a health care provider. If they feel that the patient meets the criteria for testing, providers will refer patients for testing.
Types of COVID-19 Tests
There are currently two types of active-virus diagnostic tests for COVID — molecular (RT-PCR) and antigen. A third type determines if a person has had the virus already — serology (blood) antibody. Thus far, the FDA has only approved molecular tests for home use. However, several companies are working on at-home versions of the others.
The molecular test is currently considered the “gold standard” of diagnostic testing. It uses a reverse transcription-polymerase chain reaction (RT-PCR) technique. The test works by copying an RNA sequence of the virus in a sample, then using it to detect matching genetic material in that sample.
The at-home RT-PCR is just as accurate as the provider-collected tests, according to a United Health Group study, correctly identifying 90% of positive patients.
How Does COVID-19 Home Testing Work?
Home collection kits currently come in two types: nasal swab and the newer saliva test. Some swab tests use the 6-inch swabs needed for earlier testing methods, while others use the normal-sized swabs like the kind you have in your bathroom.
Both tests can be ordered online with a prescription. Both also need to be shipped back to the lab for processing.
Once the user receives the test kit, it’s critical that they follow the enclosed directions exactly. The first step is to register or activate the kit at the web site given in the instructions. This process is essential because it connects the user to the individual test received.
Collecting the specimen is straightforward for most test kits, involving a simple nasal swab or a saliva sample. Instructions are easy to read and follow, though, again, the user must follow them carefully.
Users will also receive clear shipping instructions for returning samples to the lab. These are also critically important. Timing is vital, as test specimens remain viable for only a few days. Some labs don’t process tests on weekends, for example, so users must be sure to choose a testing day that will allow the tests to arrive at the lab on a processing day.
How Reliable Are COVID-19 Home Test Kits?
There are several methods for measuring the accuracy of a COVID-19 test. One is sensitivity — how accurate the test is in detecting a positive result. The other is specificity — how often the test gives false negatives.
In terms of specificity, most of the molecular tests are 100%. Occasional false-positive results are usually due to technical errors or contamination.
Sensitivity, on the other hand, is not as easy to measure.
According to Harvard Health, several factors influence the accuracy (sensitivity) of COVID-19 testing. For home-test users, the accuracy will depend upon how carefully they follow the collection and shipping instructions.
As for the sensitivity of a test, at least one study has found that it’s not easy to be certain of sensitivity because of differences in study design, methodology, and terminology.
A test’s accuracy will also depend on how long ago the user was exposed to the virus. If collection is done within a few days of the time of exposure, a person may not yet have enough of the virus to detect. In this case, they will show a false negative result. Again, the user should take this into account when choosing a day to collect their sample.
If all instructions are followed, false positives are rare. A person who tests positive will almost certainly have the virus. False negatives, however, are more likely. Several studies have found up to 30% false negatives. False negatives are sometimes the result of test timing, collection errors, or improper handling or shipping.If you are still having symptoms after a negative home test result, the best advice is to call your provider about an in-office test.
Does Insurance Cover COVID-19 Testing?
COVID-19 testing is technically free, thanks to the Families First Coronavirus Response Act. However, most testing companies require payment upfront with reimbursement later. Users should check with the labs to find out what costs they may have to cover.
How to Get the Best Results Using Home COVID-19 Tests
There are some things people MUST do to ensure an accurate test result. According to the FDA, these include:
- Use only tests that are regulated by the FDA. Ask the vendor who is selling the test, or check Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2 on the FDA site. If the test you use is not regulated by the FDA, the test may be unsafe or ineffective.
- Read the label on your kit and all instructions carefully before you begin. Study the pictures to be sure you understand precisely what you need to do before you collect your sample.
- Follow all instructions, or you may not get an accurate result. Most home tests have specific timing, materials, and sample amounts. Check the expiration date, and be sure you know how to store your sample before shipping.
- Keep good records of your testing.
- Call the 1-800 telephone number listed on your home test with questions.
- If you believe your test results are wrong, call your doctor. All tests can give false results.
- Don’t make any medication changes after you receive your test results without talking to your doctor first.
For more information about getting the most accurate result from home testing, visit the FDA site.
Beware of Fakes
The government has warned that many products are sold online that claim to be tests or treatments for COVID-19. The FDA maintains a running list of fraudulent products that are sold as COVID-19 tests or treatments. Anyone considering a purchase of any COVID-19 product should first check the running list that the FDA maintains of products it has debunked.
For great tips on how to avoid being scammed by fake COVID-19 products, check out the FDA’s YouTube video.
There’s also a lot of misinformation circulating about COVID-19, treatments, vaccines, health measures, and more. A good rule of thumb is to always seek advice and recommendations from trusted sources. These four sites are the best places to find accurate information:
- Food and Drug Administration (FDA).
- Centers for Disease Control and Prevention (CDC).
- Department of Health and Human Services (HSS)
- National Institute of Health (NIH).
A Final Word
Coronavirus home testing could be a game-changer for many people, particularly those who are high-risk and don’t want to chance a visit to a medical environment to get tested. And the tests keep getting better, from swabs to less-intrusive saliva tests to the rapid antigen tests and home antibody tests now in development..
For now, though, social distancing and good hand-washing are still the best protection.
Interested in learning about the other products we carry? Visit the eDrugstore blog for more trusted medical information.