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The First FDA Emergency Use Authorized
At-Home Saliva COVID-19 Test
Our self-collected testing kit for COVID-19 uses a hassle-free saliva sample to determine if you are infected with the SARS-CoV-2 virus. We’ve partnered with RUCDR Infinite Biologics lab operating under the Emergency Use Authorization guidelines issued by the FDA. Our testing kits ship with priority postage for the fast delivery to your home and back to the lab. Within 72 hours of the lab receiving your sample, you will receive secure digital results.
Saliva Collection Tube
Digital Results Available Within:
72 hours of the lab receiving the sample
Before purchasing this test, you must complete an eligibility questionnaire developed in accordance with the Centers for Disease Control and Prevention (CDC) recommendations.
This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories. This test has not been FDA cleared or approved. This 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.
How It Works:
Take the Assessment
Complete a questionnaire to assess your risk of infection. Based on conditions set by the CDC, our system may qualify you for at-home testing.
Collect Your Sample
Carefully follow the onscreen instructions and proceed to collect your saliva in the provided tube. Then return it using the included shipping return mailer.
Await Your Results
Results will be made available within 72 hours of the lab receiving your sample. Please view your results immediately and follow the recommendations given.
Who Should Get Tested for Coronavirus?
- Everyone should complete the questionnaire to get your risk of COVID-19 assessed so we can contact you when tests are available for your risk level.
- Tests will only be given out based upon likelihood of infection per CDC guidelines and national testing capacity.
- However, if you are not qualified for a test at first, you may be once testing capacity increases and we will alert you automatically when tests become available to people at your risk level.
Your Test Results
Secure Digital Results
1health’s laboratory partner for COVID-19 testing RUCDR Infinite Biologics has had their validation data and reports reviewed by the FDA under the Emergency Use Authorization (EUA) framework.
What Happens Next
There is currently no vaccine or treatment for COVID-19; however, your results can help guide how to care for yourself and protect your family and community. Your results will be reported to state and federal public health authorities to help inform the crucial ongoing public health response.
1health tests are evaluated and approved (if appropriate) by a board-certified physician.
Certified Partner Lab
Our partner lab RUCDR Infinite Biologics is CLIA-certified (Clinical Laboratory Improvement Amendments). This means they have to meet high standards to obtain both state and federal certifications and submit themselves to regular inspections.
Noninvasive Collection Method
We use a simple and effective saliva collection method. This method enables you to collect your own sample and is more comfortable than other methods such as nasal swabs.
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