Additional COVID-19 Test Home Collection Kit DTC FAQs

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Is your collection kit authorized by the U.S. Food & Drug Administration (FDA)?

Yes, the Everlywell COVID-19 Test Home Collection Kit DTC and our lab partners have received Emergency Use Authorization from the FDA.

This home collection kit has not been FDA cleared or approved. This home collection kit has been authorized by FDA under an EUA. This home collection kit has been authorized only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Will the collection kits be available in all 50 states?

The COVID-19 Test Home Collection Kit DTC is available in all 50 states. 

Will collection kits be available internationally?

No, we only operate in the U.S. today.

Where are the collection kits made?

All of our collection kits are assembled in the United States. 

What does this test measure?

The samples collected using the Everlywell COVID-19 Test Home Collection Kit DTC are meant for rt-PCR tests (a specific kind of molecular PCR test) that look for the presence or absence of unique genomic markers of the SARS-CoV-2 virus using a nasal swab for sample collection. 

Is the nasal swab in your test safe and easy to use? 

The COVID-19 Test Home Collection Kit DTC will include everything you need to safely collect your sample in just a few minutes including detailed print and video instructions to walk you through the process. This is a widely used type of swab for COVID-19 testing. 

What happens if I don’t collect my sample correctly?

In certain cases, if you are not able to provide an adequate sample, it is possible that our partner lab will not be able to determine your test results. A member from our telehealth partner will reach out to help you determine next steps and likely recommend that you self-quarantine to avoid community spread if you are experiencing symptoms.

We are the leader in teaching people how to collect finger-prick blood, stool and other swab samples. We try to make sample collection as simple and straightforward as possible through printed instructions in your kit, as well as digital and video instructions at everlywell.com/collect and provided via email. Our Customer Experience Team is available if you have any questions

What role do medical providers have in your testing? 

As with all of our products, COVID-19 Test Home Collection Kit DTC requests and results will be reviewed and approved by an independent board-certified physician. If your results are positive, our telehealth partner will contact you at no additional charge to guide your next steps. As required by law, both positive and negative results will be reported to state public health authorities. 

Is it safe to send COVID-19 samples in the mail?

Everlywell collection methods follow COVID-19 infectious disease sample collection recommendations provided by the United Nations Committee of Experts on the Transport of Dangerous Goods (UN). We provide appropriate shipping materials to safely ship your sample to our partner labs. We have years of experience handling infectious disease samples and have safely processed thousands of infectious samples during that time. 

We recommend that our customers take precautionary measures when collecting their sample by washing their hands thoroughly, disinfecting surfaces where they will be collecting their sample and using the provided alcohol prep pad to disinfect the shipping sleeve before placing your sample in the mail (though be sure to not wipe the shipping label which could impact legibility). 

At-home collection can also reduce the risk of exposure from visiting doctor’s offices, hospitals and medical facilities. Everlywell provides detailed instructions in our test and online for safe collection and transport of COVID-19 samples. You can find more information on our blog as well as safety tips for COVID-19 prevention and treatment here. 

Will the packages be marked so the postal workers know that they're handling it?

Yes, packages will contain the appropriate markings to indicate biological substances with the appropriate classification according to UN guidelines (UN3373 Biological Substance Category B). 

What about sample stability?

Samples are generally stable for 4 days. We provide prepaid shipping materials for overnight shipping and the sample must be shipped on the same day it is collected. Your sample will not be processed if you do not ship on the same day the sample is collected. 

Do you have any peer-reviewed studies about COVID-19 testing? 

There are no complete studies about COVID-19 tests themselves. Benchmarks for the accuracy of PCR testing for SARS-CoV-2, the virus that causes COVID-19, have been set by the FDA and must exceed 95% at measurable concentrations. The assays used by Everlywell meet or exceed these criteria from the FDA. You can find more information about the FDA EUA guidelines here.

What will my results tell me?

The results will tell you whether you have tested positive for SARS-CoV-2 Coronavirus, also referred to as COVID-19 or coronavirus. Individuals with positive results will be offered a telehealth consult with an independent board-certified physician.

If you have a positive test result, it is very likely that you have COVID-19. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms. 

Treatment includes managing symptoms and limiting your exposure to other people to protect from spread of disease. 

Your results will be reported to state public health authorities to help inform the crucial ongoing public health response.

In certain cases, you may not receive a definitive result because of early infection or inadequate sampling. If this happens you will be contacted directly by a doctor to help you with planning your next steps. 

The test can sometimes show a negative result even if you are infected with SARS-CoV-2, the virus that causes COVID-19. This can happen if:

  • It is too early in infection for the test to detect the virus.
  • There was a problem with your sample or the test itself. A false-negative result on this test may be more likely to occur if your sample was not shipped back to our lab the same day it was collected.              
  • If your results are negative and you’re having symptoms, continue to follow isolation precautions and ask your healthcare provider if you need further testing.
  • If your results are negative and you don’t have any symptoms, continue to monitor for any symptoms up to 14 days after your last possible exposure.

Who will have access to my results?

Only you will have access to your personal results, although positive results for COVID-19 are considered “reportable diseases” and must be communicated to mandated public health reporting agencies. This information is used to track new infections for the purpose of public health awareness and response. Your results will not be shared with your insurance company or any other healthcare providers unless you choose to share your results with your healthcare provider.

What does DTC mean?

DTC is an acronym for Direct-to-Consumers. This addition to the product name reflects our new FDA Emergency Use Authorization, which allows us to offer our collection kit directly to consumers without an eligibility screener.

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