FREQUENTLY ASKED QUESTIONS BY PRACTITIONERS
What's the Typical Reporting Time?
Reporting typically takes 2-3 weeks depending on how many samples we have in lab at the time yours is received.
The Rush option guarantees results within 5-7 business days.
Insurance
DNA ConneXions® does not participate, accept or file with any insurance company. Your paid invoice will have a suggested CPT medical code to use with your insurance communication (DNA ConneXions® Lyme Panel CPT Code: 87799). We have had some clients report successful reimbursement by their insurance companies, but that would be on a plan specific basis.
Antibiotics and Wait Time
As most of the constituents of both the Lyme and Oral Panels are bacteria, antibiotics and other treatments can absolutely affect the results. As far as how long to wait to test after the antibiotic course is complete we do not know, as every persons microbial load will be affected differently. Please consult your prescribing practitioner.
We do not have a MD on staff to make recommendations regarding current, past, or future antibiotic treatments. What we say is that testing results establishes a baseline for possible future treatments under the supervision of a lyme literate practitioner.
Chronic vs. New Infection
Theoretically we should be able to detect the organisms that we are targeting at any stage of infection. However that is not always the case. We are best able to detect organisms involved in long term, chronic infections. Likely because those populations have had time to establish themselves and proliferate.
The term dissemination is used to describe the time it takes for the organisms to all but leave the blood stream and move out to the joint, tissues and lymph. The timing of dissemination is different for every person, therefore the timing of testing for a newly acquired infection is unknown.
The protocol we use, PCR, is inherently specific, being that it is a direct testing methods, only targeting/amplifying the DNA of the target organisms themselves. In the absence of these specific targets the reaction will not proceed. Dilution studies have shown that we can detect as few a 10 organisms in a sample.
Collection from Babies
We can understand how this might be challenging. Not only to collect enough urine for the testing (30mL minimum), but also to do so in a sterile manner.
While provocation is highly recommended it is not required for testing. Massage therapy would be the best option in this case. We recommend discarding the first sample produced after provocation and attempt to collect the next one.
If needed, store the sample in the refrigerator and add to it to increase volume. However, do not collect in any other container and transfer to the urine cup.
We would also not recommend ‘ringing out the diaper to achieve a sample’.
DNA Vs. Immunological Based Assays
The DNA ConneXions® assay is a direct testing method designed to detect the DNA of the causative organism(s) itself. On the other hand, an immunological based assay is an indirect testing method designed to detect antibodies produced in response to the infection. Our direct testing method is not dependent on the stage of infection or the patient’s immunological response.
While we can detect as few as 10 organisms in a sample, our limitation is being able to detect what is in the sample provided. If there are no microbes present in the sample we could encounter a false negative result. This is why we highly recommended some sort of physical provocation before sampling, although it is not required for testing. DNA ConneXions® recommends either exercise above and beyond your usual physicality or the deep tissue, lymphatic massage as preferred forms.
While it has been demonstrated that the urinary tract is a site of spirochetal persistence, thus making urine a good reservoir for sampling, the goal of provocation is to achieve the most comprehensive sample possible. As we know these organisms reside in the joints, tissue, and lymph. The goal of physical provocation is to literally push and release these organisms from these areas. The recommended one hour wait is to allow the time necessary for these released organisms to migrate down to the urinary tract.
Please also watch the informational video with regards to collecting, packaging and shipping your sample.
The 88 Microbes
As company policy we do not release the list of the 88 microbes included on the Oral Panel as it is considered proprietary information.
However, if there are particular microbes that you are looking for I able to confirm whether or not they are included.
Testing During the Menstrual Cycle
Although we have not done a challenge study on this, we advise waiting until the menstrual cycle is over to collect for testing.
Testing and New York
Our laboratory cannot accept payments or samples originating from the state of New York.
While we are a CLIA certified biosafety level 2 laboratory, the state of New York has its own set of requirements that we choose not to participate with. Therefore, DNA ConneXions® cannot accept, process, or report on samples originating from New York.
About the DNA ConneXions® Lyme Panel
The DNA ConneXions® Lyme Panel is a direct DNA PCR test. We utilize the polymerase chain reaction to directly amplify (copy) the DNA of the targeted causative organism(s), if present. The technique targets unique genetic sequences in each of the organisms on the panel at the species level.
In addition to Borrelia burgdorferi, the causative agent of Lyme Disease, each sample is also tested for the following:
Babesia divergens
Bartonella bacilliformis
Ehrlichia chaffeensis
Borrelia recurrentis
Borrelia miyamotoi
Babesia duncani
Bartonella henselae
Babesia microti
Bartonella quintana
Anaplasma phagocytophilium
Our species specific primers are screened against Genbank to ensure they retain their species specific target regions, and we utilize DNA sequencing data to ensure the amplification products are the sequences being amplified.
The is no ‘gold standard’ in Lyme testing. While many practitioners rely on Western blots to diagnose Lyme disease, this technique target an individual’s antibodies produced in response to an infection. We know that this organism has evolved to evade the immune system, and long term, chronic suffers may or may not even be producing antibodies in response to the organism.
Our panel is based on a urine sample, and while it has been demonstrated that the urinary tract is a site of spirochetal persistence, thus making urine a good reservoir for sampling, DNA ConneXions® highly recommends some sort of physical provocation before sampling, although it is not required for testing. DNA ConneXions® recommends either exercise above and beyond your usual physicality or the deep tissue, lymphatic massage as preferred forms provocation.
The goal of provocation is to achieve the most comprehensive sample possible, as we know these organisms reside in the joints, tissue, and lymph. Provocation is to literally push and release these organisms from these areas.
The recommended one-hour wait is to allow the time necessary for these released organisms to migrate down to the urinary tract.
ilution studies have demonstrated that we can detect as few as 10 organisms in a sample, however, our limitation is being able to detect what is in the sample provided. If there are no microbes present in the sample, we could encounter a false negative result.
Questions? Please call us 1(888) 843-5832.
The Oral Panel Lab Re-Run Policy
The Oral Panel was designed to provide patients and practitioners a comprehensive view of patient health based on the oral flora. This panel detects 88 different microbial pathogens including bacteria, viruses, fungi, yeasts and parasites.
Organisms found in the mouth range from normal oral commensals to disease causing pathogens. Any pathogen that exists in the human mouth can cause health problems or disease in other areas of the body if the organism leaves the mouth through oral trauma or other dissemination pathways. Therefore, this information is valuable to all practitioners, including those outside of dentistry.
The average number of microbes detected on the Oral Panel is between 12-17. If we detect less than 6 the samples qualify for a ‘laboratory rerun’. Meaning we retrieve the original sample and perform all laboratory steps again (DNA purification, quantification, inoculation, amplification, and visualization). An entirely second panel is done from start to finish.
This takes the possibility of laboratory handling of the sample out of the explanation as to why the sample yielded few to no microbial findings. As was the case of your sample. 95% of the reruns that we perform at DNA ConneXions® yield no change in results. It is rare, but sometimes samples yield few to no results.
Shipping to Countries Outside of the United States
Shipping outside the U.S. is typically not a problem.
Please provide your complete mailing address when purchasing your test(s). If you run into any issues, please contact us at 1(888) 843-5832.
Preferred Pricing Discount
After we receive 10 Lyme samples attached to your clinic you will qualify for preferred practitioner pricing. If you choose to do so you may keep a credit card on file with DNA ConneXions®.
We will bill you directly for the samples received at the discounted rate of $500.00/panel. You, in turn, can bill your patients as you see fit for your testing and interpretative services. Our website prices the Lyme Panel at $650.00.
Please contact us at 1(888) 843-5832 with questions.
Provocation
While provocation is highly recommended it is not required for testing. DNA Connexions recommends either exercise above and beyond your usual physicality or the deep tissue, lymphatic massage as preferred forms.
While it has been demonstrated that the urinary tract is a site of spirochetal persistence, thus making urine a good reservoir for sampling, the goal of provocation is to achieve the most comprehensive sample possible. As we know these organisms reside in the joints, tissue, and lymph. The goal of physical provocation is to literally push and release these organisms from these areas. The recommended one-hour wait is to allow the time necessary for these released organisms to migrate down to the urinary tract.
Please also watch the informational video with regards to collecting, packaging and shipping your sample.
Urine vs. Oral Samples
The Lyme Panel was designed to utilize a urine sample, however we can test an oral sample on the Lyme Panel.
Please keep in mind that the urine sample is considered to be a more comprehensive body sample, whereas an oral sample would be considered to be a more site specific sampling method.
Sensitivity and Specificity
The DNA ConneXions® Lyme Panel utilizes PCR which is an inherently sensitive and specific molecular technique. The species specific primers will not anneal if the target DNA is not present, and therefore not produce amplification products in the absence of their target sequences.
Dilution studies of positive control B. burgdorferi has shown that we have the ability to detect as few as 10 organisms in a sample, if present. Amplification products are sequenced to confirm identity as compared to Genbank, as well as the specificity of the primers. Without a ‘gold standard’ of testing for Lyme, it is our internal studies, running known negative and known positives, and sequencing data to confirm the identity of the results.
Our limiting factor is false negatives, meaning the target DNA was not present in the sample, which is why some sort of physical provocation is highly recommended prior to sampling.
Refunds
According to the terms and conditions that you must agree to when you purchase your panel online, there are no refunds on purchased tests.
By checking this box to complete your purchase, you are agreeing to the following terms and conditions:
- We do not service the New York area. Please call your governor’s office and file a complaint should you wish to see this restriction removed.
- DNA ConneXions® does not currently work with any insurance providers and we do not accept insurance.
- In order to return valid test results, it’s critical that directions are followed exactly as they are provided. Failure to do so may yield inaccurate results and a new test will have to be completed. PLEASE BE ADVISED that the cost of a new test kit is $50. If you have questions about specimen collection on any of our tests, please visit our FAQ page, or contact us directly: 1-866-624-5116.
- We are unable to issue a refund on purchased tests.
The Lyme Panel kit does not expire, so you can retain it to use in the future.
UPS and FedEx
We have a 48-hour sample return timeline, therefore, we recommend only posting return samples Monday, Tuesday or Wednesday.
There is no one at the lab on weekends to accept samples.
We also recommend that samples are dropped at the carrier (either FedEx or UPS depending on which label you received) earlier in the day to ensures it leave the facility the same day.