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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
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:
Order Test Kit
Place a kit order and your test kit will be delivered promptly
Collect Your Sample
Everything you need is included, and collection takes only a few minutes. Use the shipping return mailer to send your sample to the lab.
Receive Your Results
Once the lab receives your sample, you will get your test results and recommendations within 72 hours.
Who Should Get Tested for Coronavirus?
You should get tested if:
- You have symptoms of COVID-19 such as fever, cough, or shortness of breath.
- You may have been exposed to someone infected with COVID-19.
- You live or work in a place where people gather in close proximity including schools, offices, healthcare settings or assisted living facilities.
- Your employer, public health department, contact investigator, or healthcare provider has identified you as someone who should get tested.
If you have further questions about your eligibility for COVID-19 testing, we recommend reaching out to your primary healthcare provider to see if testing is right for you at this time. If you are experiencing severe or life-threatening symptoms, please seek immediate medical care from a healthcare professional or call 9-1-1.
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
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 Infinity BiologiX 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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