Frequently Asked Questions
How accurate is the Wheeler Labs’ test?
- Sensitivity = 97.1% In other words…
- We will identify an infected person 97.1% of the time
- A positive result is correct 97.1% of the time
We will miss an infected person 2.9% of the time
- Specificity = 98.2% In other words…
- We will accurately tell an uninfected person they are negative 98.2% of the time
- A negative result is correct 98.2% of the time
- We will report a false positive result 1.8% of the time
- The accuracy of the test is highly dependent on the SARS-CoV-2 information provided by the CDC. This is the same scientific basis and similar accuracy for any test that may be called a “gold standard test” “PCR test” “RT-qPCR test” “qPCR test” or “RT test.”
Who are we?
Wheeler Labs, LLC is a diagnostics testing lab established in 2020 and located in Oklahoma City, Oklahoma.
Where is our test valid?
Wheeler Labs can provide testing for people living inside the United States, with the exception of these states: Alaska, California, Hawaii, Maryland, New York, Pennsylvania, Rhode Island.
Where are the fact sheets about the Wheeler Labs COVID-19 test?
What are Wheeler’s qualifications to perform COVID-19 testing?
Our state-of-the-art laboratory is CLIA-certified. Our RT-qPCR test has been granted an Emergency Use Authorization (EUA) from the FDA. Our leadership staff has more than 60 years’ experience working in FDA-regulated industries related to healthcare.
This home collection kit itself has also been granted EUA by the FDA for at-home, non-supervised collection of saliva to detect nucleic acid from SARS-CoV-2. It has not been approved to detect any other viruses or pathogens.
Who can get a test?
Anyone in the continental US can order a test kit. Wheeler Labs has partnered with a national network of board-certified physicians to review your submission and approve the test. Wheeler Labs’ physicians will approve all requests for a test.
What is the cost of testing?
$125 for an individual, plus additional cost for shipping (options available at checkout). If you have a group over 10 or would like to deliver/pick-up in person, contact us.
Do you process insurance?
Wheeler Labs does not currently process insurance claims. You may be able to pay with your FSA or HSA debit cards. Verify with your insurance provider before purchase.
How do I get reimbursed for my test?
The Coronavirus Aid, Relief, and Economic Security (CARES) Act provides that, under certain circumstances, laboratory testing for the viral (RT-qPCR) must be reimbursed by insurance. Wheeler Labs can provide you with an itemized receipt, ICD-10 and CPT codes, and other information necessary for you to file a claim. More information regarding the cares act can be found at the following links:
Will this test get me cleared to travel?
Our test results clearly state that this is a RT-qPCR test and provide our lab certification number. This is sufficient for US airlines and most travel destinations. There are some restrictions, so you should confirm with your specific destination. For example, Hawaii requires an RT-qPCR test but will only accept results from a few specific labs, and we are currently not on their approved list.
How does it work?
Once you order your kit(s), our logistics team will ship them via FedEx to your location. Follow the simple instructions contained in the kit to collect your sample in the provided tube. Be sure to follow all directions. Failure to do so may result in a delay in results or require a new sample.
Once collected, simply place your sample in the pre-paid return FedEx envelop and drop off at any FedEx location or schedule a pickup from your location. Do not drop off samples to FedEx on Fridays or Saturdays as delivery times to our lab may vary. All samples must be received by Wheeler Labs within 56 hours of the sample being taken.
Once we receive your properly collected samples, the lab will perform the test and email your results within 72 hours (however most results are returned within 24 to 48 hours of receipt).
What if I don't live near a FedEx dropbox?
You can call the number on the bag and schedule FedEx to come pick up your sample from your home at no additional charge.
Do I need a physician to prescribe the test?
No. Wheeler Labs has partnered with a national network of board-certified physicians to review your submission and approve the test. Wheeler Labs’ physicians will approve all requests for a test.
Can I use my own physician?
Yes. Any individual, employer or healthcare provider that would like to use their own physician can contact us for more detail on how to order.
How much saliva is needed?
About half a teaspoon of saliva is needed. Most adults and children should not have trouble providing a sample, although it will take a few minutes. It may be difficult to obtain this much saliva from an infant or toddler unless they are teething.
What type of test is this?
Our lab performs a molecular RT-qPCR test that is CLIA certified and has been granted an Emergency Use Authorization (EUA) from the FDA. This is the preferred method for detection of the SARS-CoV-2 virus and is superior to the “antigen” or “rapid antigen” testing method.
- This assay detects the genetic material of the SARS-CoV-2 virus (the virus that causes COVID-19) in saliva of infected people.
- The assay only detects active infections. If a person did have COVID-19 and recovered, this test will give a negative result.
- This test is classified as a high-complexity test, and takes approximately 8 hours of dedicated time for an analyst to test the samples and obtain results.
What does a positive result mean?
A positive test result shows you have an infection of SARS-CoV-2. This may be the case even if you are not exhibiting symptoms. You should immediately consult your doctor about next steps, which should include a discussion about isolation to prevent spreading the virus. If you used our in-house physician network, they will contact you to discuss next steps.
What does a negative result mean?
If you test negative for SARS-CoV-2 by our test, it means that you did not have an active infection with this virus at the time you submitted the sample. It is still possible you had COVID-19 and recovered before you submitted your sample. It is also possible you can contract COVID-19 at a future date.
What is the shelf-life of the kit?
The kit is good for 2 years and should be stored at room temperature. If you ever wonder about kits you may have at your house, the expiration date is printed on the saliva collection tube.
Do you report results to the local health departments?
Yes, we report all results as required to the state in which the patient was located when they took the test. We cannot currently report results to CA, PA, HI, RI, NY, MD.
What does ‘inconclusive result’ mean and why does this occur?
All PCR tests look for 2 different parts of the virus. For a positive result, both parts must be detected. For a negative result, both must be missing. Infrequently, one part of the virus may be detected but not the other. This can happen for a couple of reasons:
- Although infrequent, the detected portion may be random noise. Likewise, the missing portion may be random interference in the assay. This can be addressed by rerunning the assay on the same sample. The chances of getting the same result randomly are astronomically low. At Wheeler Labs, we automatically rerun any sample that has an inconclusive result before we report results to you.
- There may be some contamination or interference in the sample. PCR assays are extremely sensitive and can pick up RNA from any leftover food in your mouth. All living things have RNA! The assay can also be blocked by certain chemicals in food. There may be a signal or interference coming from your lunch, coffee, gum, chewing tobacco or any other food item. This is why we ask that you wait 30 minutes after eating or drinking before submitting a sample. If an inconclusive result is obtained twice, the assay will need to be repeated on a fresh sample.