A saliva-based molecular test, which is authorized by the FDA under an Emergency Use Authorization (EUA), that can be self-collected and shipped to our lab for testing. The results of the test can confirm if the virus is detected in the saliva of an individual. See FAQs or call for more information.
How is the sample collected?
The sample is self-collected utilizing this kit and your mobile phone or tablet. Specific instructions are included in the collection kit along with the supplies needed to ship the test kit to the laboratory for testing.
How do I receive results?
Results will be available on your mobile device within 72 hours of receipt at the laboratory. Instructions to securely access results are included.
Can I order tests for friends or family members?
Yes. you can order as many test kits as you choose. Each kit will have everything needed to collect the specimen and ship it to the laboratory. Each kit will be registered by the person completing the testing using their mobile device. You do not need to disclose who the kits are for upon ordering.
What does it mean if I have a positive test result?
If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false-positive result). You will be contacted by a medical professional who will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
What does it mean if I have a negative test result?
A negative test result means that the virus that causes COVID-19 was not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test result is negative. If your test is negative, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, the FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s(HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs unless it is terminated or revoked by FDA (after which the test may no longer be used).
How-to Video for using this kit