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COVID Testing for Organizations

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, 2020. This saliva test and saliva collection device are FDA-authorized for at-home self-collection in the U.S.

For more details, please review the following:

Patients: https://www.fda.gov/media/137771/download 

HCPs: https://www.fda.gov/media/137774/download

Is this test covered by insurance?

Yes. Patients who self-pay will receive a receipt highlighting the cost of the test and the visit with a healthcare practitioner.  They can then submit this receipt to their insurance company for reimbursement, which will be at the discretion of the insurer. The receipt can be attached to an insurance carrier’s Claim Form to request full reimbursement for the test, which we believe would be widely available pursuant to the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).

Vault also accepts HSA/FSA funds.   

Are there enough tests for my organization?

es. Current testing capacity is 30,000 tests per day. Capacity is being added very quickly to scale to 50,000+ tests per day. 

How does this test work?

This is a polymerase chain reaction (PCR) test. It is a relatively simple and widely used molecular biology technique to amplify and detect DNA and RNA sequences and takes only a few hours. The test detects the expression of three genes specific to the SARS-CoV-2 virus, the N, S, and ORF1ab genes. Viral RNA is extracted from the patient’s saliva sample and the presence of gene sequences is assessed. If the presence of 2 or 3 of these gene transcripts is confirmed, the test is considered POSITIVE.

How accurate is this test?

The assay can detect the virus down to fewer than 10 copies per milliliter of saliva, which is highly sensitive. In practice, 98% of test results are either positive or negative, with only 2% being inconclusive.  The sequences that help to detect the virus (primers) match the viral sequences almost 100% of the time, which ensures that the test is specific only to the 3 selected viral genes, which in combination are only found in the SARS-CoV-2 virus.

Should I consider an antibody test versus this one?

A COVID-19 antibody test is a blood test that can tell if you previously had COVID-19 and have since recovered. The test involves having your blood drawn at a healthcare facility. It checks for the presence of a particular antibody your body makes when it’s fighting the virus. These antibodies appear in your bloodstream after you’ve been infected. An antibody test is not the same as a nasal swab PCR test and does not check for the presence of the virus that causes COVID-19. You should not get an antibody test if you’re currently experiencing symptoms of COVID-19 or need to know if you are currently infected. 

The global scientific and medical community still has much to discover and learn about the virus and its resulting disease. For the individual patient, an antibody test is currently unlikely to change your medical management or what precautions you need to use such as physical distancing or masking in public. At this time, the antibody test is most useful to understand how much the disease has spread in the community and potentially predict if a second surge of cases is likely to occur. The results may also help develop new treatments and even a vaccine. 

One challenge with current antibody tests is that there is a high likelihood (almost 50% for some tests) of having a “false positive” result. This means the test will be positive when the person has never had the disease. This is true for all COVID-19-related antibody tests, including very good ones.

How often should an individual be tested?

This question is answered in the context of infection risk to others. If an individual has responsibilities that include regular contact that could increase risk of transmission between themselves and others, it may be necessary to test more frequently. With limited contact tracing available today, it is dependent on individuals to maintain social distancing guidelines and use of appropriate PPE (masks, gloves) to avoid potential exposure

The scientific and medical community believe most who are infected with COVID-19 are asymptomatic or may not manifest any known symptoms of an infection. This test will confirm infection between 2 and 28 days since exposure to the virus.  A negative test confirms that the individual has not been infected and is “safe” as long as they continued to maintain vigilance from the time they took the test to receiving the results.

How can my organization conduct supervised on-site training?

Vault will provide a simple tutorial for administering tests on-site. A trained medical professional will be able to facilitate this process.

The test subject will need internet access to use a web link provided by Vault. The test subject will complete a simple online form and enter the test tube ID# to complete test registration. The test supervisor will guide the test subject through the saliva specimen collection, capping the tube and inserting into a bio bag, and wiping it down with an alcohol pad. 

The test supervisor will package all collected specimens into a provided overnight clinic package to the lab. Results are emailed to the test subject and available to the organization with consent.

What’s included in the test kit?

Each test kit includes an instruction card, saliva collection device, biohazard bag, alcohol pad, and prepaid overnight return envelope.