What is the process for any tests that require “Observed Collection”?

The patient should register their kit when they are ready to take the test. (This should be within the required time-frame, if any, per their destination.) During the registration process there are questions regarding their destination, specifically if the test is for travel to (Turks & Caicos), (or Hawaii), etc. (They should select “Yes” as … Read more

How do HOLIDAYS affect timing of test results?

Plan ahead. Order your test right away to ensure you have it in time for the day you plan on testing. We advise that you order your test at least one week before you plan on taking it. Travel during major holidays to locations that have results timing restrictions (like Hawaii) will need to be carefully planned. … Read more

How does the test work?

This RT-PCR test detects specific genes from the SARS-CoV-2 virus, which is the virus that causes COVID-19. After you provide a sample of your saliva, the virus’s genetic material is extracted from it and these specific genes are looked for in a laboratory.  If they are there, the test is considered positive.

Is this test authorized by the FDA?

Yes. This assay is intended for use under the Food and Drug Administration’s Emergency Use Authorization #200090 authorized on April 10, 2019. This is the only saliva test and saliva collection device that is FDA-authorized for at-home self-collection in the U.S. at this time. See the EUA here.

How accurate is this test?

This RT-PCR test is very sensitive for the presence of SARS-CoV-2, with 98% of tests providing either a positive or a negative result, and only 2% of tests providing an inconclusive result. The test can detect fewer than 10 copies of viral genes per milliliter of saliva, and can detect the presence of virus in the … Read more

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