SalivaDirect™ at-home testing

As the research lab behind the development of the open-source SalivaDirect™ test, our EUA from the FDA permits us to designate clinical laboratories around the US to test with the SalivaDirect™ protocol. While our SalivaDirect™ team does not offer direct diagnostic testing of the public, we have partners who do! Read more to learn about if this option is a good fit for you or your community.

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What is the SalivaDirect™ at-home option?
How do I get a test?* (For individuals)
How do I get a test? (For diagnostic Labs)
Physician order required?
Where do I take the test?
How do I return my sample?
How do I receive my results?
Who can I order a test from? (For individuals)
Who can I order a test from? (For diagnostic labs)
What SalivaDirect™ test should I use?
How much does a test typically cost?*
Will the SalivaDirect™ test detect all variants of the virus?
Is the SalivaDirect™ test acceptable for travel?
How long will it take to receive my results?
Is there a sample video that I can view/share that shows the process?

What is the SalivaDirect™ at-home option?: With SalivaDirect™ At-Home Collection, individuals in need of COVID-19 testing can receive the necessary materials and information to collect their sample in a clean, sterile way that will enable accurate testing in the privacy of your home.

In order to provide a viable sample, participants must follow the collection instructions included in the kit and drop their packaged sample off at a FedEx or UPS drop box. Please follow all instructions included with the test kit.

Once a sample has been mailed, it will be processed by the lab using the FDA EUA SalivaDirect™ test and results will be available online with a provided registration code.
How do I get a test?* (For individuals): At-Home Kit

Order online from labs and suppliers (see below for more details).

Direct-to-Consumer (DTC) Kit

Order online from labs and suppliers (see below for more details).

Unsupervised collection

Provided by a lab near you.

*SalivaDirect™ is the research team that developed the open-source SalivaDirect™ protocol; we do not do any diagnostic testing ourselves. However, you can contact one of our authorized lab partners to learn more; those that have given us permission to share their contact details are organized by state here: https://www.salivadirect.org/authorized-labs.
How do I get a test? (For diagnostic Labs): At-Home Kit

Kits must be ordered from authorized supplier.

Direct-to-Consumer (DTC) Kit

Kits must be ordered from authorized supplier.

Unsupervised collection

Kits can be made by your lab per our EUA IFU -OR- can be ordered and customized to your lab needs, here at GS Biomark!
Physician order required?: At-Home Kit

Yes.

Direct-to-Consumer (DTC) Kit

Not needed.

Unsupervised collection

Yes.
Where do I take the test?: At-Home Kit

Wherever you want! No supervision required.

Direct-to-Consumer (DTC) Kit

Wherever you want! No supervision required.

Unsupervised collection

Wherever you want! No supervision required.
How do I return my sample?: At-Home Kit

Return via mail with shipping label included in the kit.

Direct-to-Consumer (DTC) Kit

Return via mail with shipping label included in the kit.

Unsupervised collection

Drop off at the collection point identified by the lab you order from; this kit cannot be mailed, it must be returned by foot, car, bike, etc.
How do I receive my results?: At-Home Kit

The kit will come with a unique code — you’ll use this to log in online and see your test results.

Direct-to-Consumer (DTC) Kit

The kit will come with a unique code — you’ll use this to log in online and see your test results.

Unsupervised collection

The lab you receive the test from and return your sample to will have an online portal or email notification to provide your test results.
Who can I order a test from? (For individuals): A number of SalivaDirect™ authorized labs have at-home collection kits available for purchase. These can be used for one-time individual testing or as part of regular community/business testing. In each kit you will receive the collection materials in the mail, directions for how to collect your own sample, and steps for sending the sample back to the lab for processing.

Reach out to a SalivaDirect™ designated lab in your area to ask about At-Home testing options. Not seeing a lab offering At-Home tests near you? Other options for At-Home kits may be found by searching online for “SalivaDirect at-home”.
Who can I order a test from? (For diagnostic labs): SalivaDirect™ At-Home and DTC kits must be ordered through the EUA-authorized supplier of these specialized saliva self-collection kits. As these kits are thoroughly reviewed by the FDA, it is not possible for labs to make their own at-home or DTC kits. Check out the DTC Playbook from our partners at Tempus to learn more.

Labs are however, able to compile their own unsupervised collection kits, as detailed in our EUA. Prefer to have some help with this? Partners such as those at GS Biomarkare available to assemble customized, premade testing kits your lab can offer to customers.
What SalivaDirect™ test should I use?: All SalivaDirect™ tests, and lab partners, follow our FDA-authorized EUA. No matter what partner lab you order a test from, you’ll get a high-quality PCR test and reliable results.
How much does a test typically cost?*: At-home kit prices vary depending on the lab offering them. To learn about pricing, contact one of our partner labs in your area.

Note: not all SalivaDirect™ labs offer At-Home or DTC options.
Will the SalivaDirect™ test detect all variants of the virus?: It all begins with an idea. Maybe you want to launch a business. Maybe you want to turn a hobby into something more. Or maybe you have a creative project to share with the world. Whatever it is, the way you tell your story online can make all the difference.
Is the SalivaDirect™ test acceptable for travel?: Most forms of travel require a negative PCR test. SalivaDirect™ tests for COVID-19 through PCR, which is considered to be a highly reliable and "gold standard" method for detecting the COVID-19 virus. We always advise double checking with the event or company through which you're traveling with or attending, as they may have their own requirements.
How long will it take to receive my results?: The turnaround time for the SalivaDirect test can be anywhere from 4 to 24 hours after lab receipt of samples, depending on the test volume and staff availability of the lab you contact. This is highly lab-dependent, however, and we recommend you directly ask a designated lab.
Is there a sample video that I can view/share that shows the process?: Yes! A sample collection video is available on our SalivaDirect™ website here; our partners at GS Biomark also have a demo video on their webpage available here!

Important Regulatory Information about SalivaDirect™

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This 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.