COVID-19 Test Kit: An
At-Home Saliva Test for Coronavirus

COVID-19 Test Kit:

An At-Home Saliva Test for Coronavirus

We have launched the first FDA EUA Authorized at-home COVID-19 Saliva test. Please take the assessment. We accept HSA and FSA.

If you are a Health Care Provider, Local Government, or Essential Business and need tests click here.

$129

How to Get the First FDA EUA Coronavirus Test Kit At Home?

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 labs operating under the Emergency Use Authorization guidelines issued by the FDA. Our testing kits ship with the highest 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.

Collection Method:
Saliva Collection Tube

Digital Results Available Within:
72 hours of the lab receiving the sample

Test Accuracy:
Sensitivity 99.99% 
Specificity 100%

FDA EUA:
https://www.fda.gov/media/137773/download (At Home amendment)
https://www.fda.gov/media/136875/download (Original amendment)

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. For more information, please refer to the patient and healthcare provider fact sheets.
If you feel like you are having a medical emergency, please call 9-1-1. If you are experiencing severe trouble breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical
care.

How the COVID-19 Saliva Test Works

Step 1:
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.

Step 2:
Order Your Kit

If approved, order your kit. Once received via express mail you must register your kit at 1health.io/register.

Step 3:
Collect Your Sample

Carefully follow the onscreen instruction at 1health.io/register and proceed to collect your saliva in the provided tube. Then return it via USPS in the complimentary express/priority shipping return mailer.

Step 4:
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.
  • If you develop COVID-19 symptoms such as fever or chills, cough and shortness of breath, or difficulty breathing, you should take the eligibility assessment. 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.

How Much Does a
COVID-19 Test Cost?

Our COVID-19 test kit costs $129 out-of-pocket, and HSA and FSA cards are accepted as payments. You may be eligible for further insurance coverage if prescribed by a doctor. However, please note we will not file claims with insurance companies. As money is disbursed from the federal government, it is possible that the cost of the test kit may be fully covered in the future. We will be monitoring any changes closely and update our customers accordingly. If you are a health care provider, you may qualify for different pricing.

COVID-19 Testing FAQs:

What are the symptoms of COVID-19?
The most common symptoms of COVID-19 are fever, cough and shortness of breath. These symptoms generally appear between 2 and 14 days after being exposed to the virus. Other symptoms may include body aches, sore throat and diarrhea.
Am I at risk for COVID-19?
The virus is highly contagious and is currently spreading rapidly. Especially if you are in an area where the virus is widespread, the best way to prevent illness is to avoid exposure to the virus. This means avoiding close contact with people who are infected and public spaces where you can come into contact with many people. You should follow any national or local guidelines around social distancing, staying at home, and wearing masks. You should regularly wash your hands and disinfect any frequently touched surfaces.
How is COVID-19 treated?
There is currently no cure for COVID-19 so treatment revolves around managing symptoms. For most people symptoms can be managed at home with rest, fluids and over-the-counter medications. However, some people experience severe symptoms and require hospitalization. If you are experiencing symptoms, contact your doctor for guidance on whether you should treat symptoms at home or go to the hospital for care.
What is the recovery time for COVID-19?

According to the World Health Organization, the recovery time for mild COVID-19 cases is ~2 weeks while severe or critical cases can last anywhere between 3 and 6 weeks.

How many test kits can I purchase?

Currently, each person who takes the quiz and is determined to be eligible by CDC guidelines can buy one test. This is subject to change as tests become more widely available.

Should I Get Tested for COVID-19?

You should get tested for COVID-19 if you develop COVID-19 symptoms such as fever or chills, cough and shortness of breath, or difficulty breathing. 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.

How do I get a COVID-19 test kit?
To obtain a COVID-19 test kit, you must complete the questionnaire to assess your risk and eligibility. If approved, you will be able to order a test kit online to assist with collecting your saliva sample.

If you are a healthcare provider, local government, or essential business, see more information for obtaining test kits here

How does the test work? What does it measure?
The test determines whether you have been infected by testing for the presence of the SARS-CoV-2 virus in your saliva. It does this by detecting unique genetic markers that are specific to the virus. This is not an antibody test and only detects whether you are currently infected.
Is this test different from tests available at hospitals and doctor’s offices?

Most of the tests currently available use a nasopharyngeal swab. Our tests are the first FDA EUA authorized saliva tests for COVID-19.

Preliminary data from an independent study from Yale University has found saliva tests to be more sensitive and consistent than nasopharyngeal swabs.

How much does a Coronavirus test cost?

Vitagene’s coronavirus test costs $129 out-of-pocket. We also accept HSA and FSA cards as payments. Health care providers may qualify for different pricing.

The total fee includes $12 collected on behalf of PWNHealth for physician oversight services.

When will I receive my test kit?

We ship our testing kits with the highest priority postage for fast delivery to your home. You can expect to receive your test kit within ~2-3 days with priority shipping. 

How do I register my test kit?

To register your test kit, please visit our partner site https://1health.io/register/ and create an account for the profile that best suits you. You will be asked to enter personal details and your KIt ID located on the saliva collection test tube. 

How do I collect my saliva sample?

To collect your sample, please follow the onscreen instructions at https://1health.io/register/ after registering your COVID-19 test kit. Your test kit will provide a tube to collect your saliva in.

How quickly will I receive my COVID-19 test results?

Results will be available 2-4 days from the time of purchase. Priority shipping to the lab is included. The lab will send your results within 72 hours of receiving your sample.

Who is PWNHealth?
PWNHealth is an independent healthcare provider network that provides oversight services to you in connection with the laboratory testing that you have requested. PWNHealth and its services are independent from the laboratory and company from whom you requested and registered for the test and their services.
Are these test kits covered by insurance?

Most insurance companies have said that they will cover COVID-19 tests prescribed by a doctor. However, we will not file claims with insurance companies. We do accept HSA and FSA cards as payment for the tests.

Where can I get tested for Coronavirus?

Our Coronavirus test kits are available in all states within the United States. They are available for purchase online once you complete the questionnaire at  https://1health.io/covid19/vitagene/?assessment. If you are a Health Care Provider, Local Government, or Essential Business, see more information for obtaining a test kit here.

Why does this test cost money?
We are currently pricing the tests as low as possible in order to cover our costs. As money is disbursed from the federal government, the cost of the test may be covered in the future.
What happens if I don’t qualify for a COVID-19 test?
If you don’t qualify for a test, you will be provided with recommendations to help you prevent illness and manage symptoms. As more tests become available, we may notify you if your eligibility for a test changes.
What does it mean for your test to be FDA EUA Authorized under an Emergency Use Authorization (EUA)?

In response to public health emergencies like COVID-19, the FDA may grant an emergency use authorization for tests that have not yet been approved through their normal review and approval processes. This means:

  • This test has not been FDA cleared or approved;
  • This test has been authorized by the FDA under an EUA for use by authorized laboratories;
  • 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.

Your Test Results

Secure Digital Results
All of Vitagene’s laboratory partners that are conducting COVID-19 testing have had their validation data and reports reviewed by the FDA under the Emergency Use Authorization (EUA) framework.

What Happens Next
You will receive your test results within 72 hours of the lab receiving your sample. Your test results will confirm whether or not you are infected with SARS-CoV-2, the strain of coronavirus responsible for COVID-19.

After you receive your results, you will have an opportunity to have a telehealth consult with an independent licensed physician or other healthcare provider, who can answer any questions you may have about your test results and help determine next steps.

Why Vitagene

Physician Evaluated

Vitagene tests are evaluated and approved (if appropriate) by an independent board-certified physician in your state.

Certified Labs

Each partner lab we choose to work with 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.

Trusted Healthcare Platform

Trusted healthcare platform that powers some of the largest health and wellness institutions in the US.

Select the profile that best suits you.

Consumers

Test yourself for Coronavirus without leaving home.

Get Tests Now

Healthcare Providers

Order a test for yourself or your patients immediately.

Request Tests

Government/ Healthcare System

Launch your own branded testing site for your population with at home testing, tracking and reporting.

Learn More

Corporations

Zero Contact™ simple, fast COVID-19 testing and reporting for your employees at home or at the office. NO nasal swabs, no clinics, or healthcare providers required.

Learn More

COVID-19 Test Kit: An
At-Home Saliva Test for Coronavirus

COVID-19 Test Kit:

An At-Home Saliva Test for Coronavirus

We have launched the first FDA EUA Authorized at-home COVID-19 Saliva test. Please take the assessment. We accept HSA and FSA.

If you are a Health Care Provider, Local Government, or Essential Business and need tests click here.

$129