FREQUENTLY ASKED QUESIONS
Please take a moment to watch our FAQ video and go through the many common questions patients have regarding the tests DNA ConneXions offers. We feel confident that answers to most of your questions can be found here but, if we’ve missed something, don’t hesitate to give us a call – 1.888.843.5832 Monday – Friday 7:00 AM to 5:00 PM (MST); we’re here to assist!
The DNA ConneXions® assay is a direct testing method designed to detect the DNA of the causative organism(s) itself. Conversely, 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.
What does this mean? Let’s use this example: Let’s say you had chicken pox as a child. Your body fought the infection and produced antibodies that you still carry around today. Therefore, if you were tested for those antibodies today, you would test positive even though you don’t have chicken pox currently.
Antibody testing only tells us that at some point you were exposed and our body mounted an immunological response. An antibody test DOES NOT tell you if the infection is active, where the DNA ConneXions® Lyme Panel DOES.
DNA Connexions is a CLIA certified BSL-2 clinical molecular laboratory specializing in the detection and identification of the genetic footprint of pathogenic microbiota.
We also look for specific genetic variations that would give our clients a better understanding of their ability to handle the environment they live in.
To identify bacterial, viral, fungal and parasitic microbes in human biological samples to provide practitioners with a comprehensive view of their patients. While the Lyme and Oral Panels detect the presence/absence of microbial DNA, the ApolipoproteinE (ApoE) and Gluten Intolerance (GI) panels provide genetic information useful in understanding an individual’s propensity for Alzheimer’s, autoimmune/neurological conditions, and Celiac Disease.
Currently, DNA Connexions offers four molecular-based laboratory assays: the Lyme Detection Panel, the Full View (i.e., comprehensive oral heath) Panel, the Apolipoprotein E (ApoE) Panel, and the Gluten Intolerance Panel. For more informaation, please see Tests Provided.
A test is ‘direct’ when it seeks to detect the presence of the organism suspected as the cause of an infection. Conversely, a test is said to be ‘indirect’ when it’s focus is on the immune response of the person who provided the sample for testing.
The Lyme detection panel is a urine-based PCR (Polymerase Chain Reaction) assay designed to detect the DNA of Borrelia burgdorferi, the cause of Lyme infection in the United States, as well as the DNA of ten common Lyme co-infectors.
No, a positive test result does not mean the tested patient has Lyme disease. Rather, it means the DNA of B. burgdorferi was detected in the sample provided. For a diagnosis or interpretation of your results, please consult your primary care or Lyme-literate physician.
This is very possible. At any given time, we literally have millions of pathogenic microorganisms (bacteria, viruses, parasites, and fungi) living within us, and the immune system is constantly fighting them. Therefore, their mere presence does not necessarily make us sick.
Lyme disease, like all other microbial infections, requires an already compromised immune system in its host.
Certainly! A ‘pathogen’ is a harmful foreign organism within the body. The ‘immune system’ is the body’s self defense mechanism. If the immune system is strong, then the pathogen will eventually be completely destroyed. However, if the immune system is compromised by poor health, the pathogen multiplies, becoming an ‘infector,’ and the resultant immune response to this pathogenic aggression is an ‘infection.’ So, applying these terms to the Lyme discussion: a) Borrelia burgdorferi is a either a temporarily co-existing pathogen or an active infector; b) Borreliosis (i.e., Lyme Disease) is an infection. The same distinction applies to the ‘co-infectors’ our panel is designed to detect. They are ‘co-infectors,’ not ‘co-infections.’ We know this can get confusing at times, but it’s vital to keep our words, and the ideas behind them, clear.
We do not advise clients regarding either the continuation or cessation of treatments prior to taking any of our tests. Some of our clients have highly individualized medical situations, which may or may not include treatment for Lyme Disease. We recommend that you consult your primary care or Lyme-literate physician for advice about any medications or other treatments you may be taking, and prior to taking our test.
The causes of infection are pathogens – whether viral, bacterial, parasitic, or fungal – and a weakened immune system.
No, DNA Connexions does not specialize in Lyme detection. In fact, the laboratory offers three other tests for its clients: the Fullview Panel, the ApoE Panel, and the Gluten Intolerance Panel.
The Full View test is a DNA PCR assay that identifies bacteria, viruses, fungi, and parasites using oral samples. It tests for 88 different pathogens, including tetanus, botulism, diphtheria, HPV 16 and HPV 18, and Candida albicans, to name but a few. For more information, please see Tests Provided.
Yes, and this is precisely why a dentist would be interested in helping medical doctors and other dentists make the differential diagnosis of mercury toxicity versus Lyme disease. Such common symptoms include: flu-like symptoms, low energy, headaches, panic attacks, swollen lymph nodes, joint pain, weakness, numbness and tingling, irregular heartbeat, tachycardia, poor memory, reduced mental focus, facial paralysis, depression, suicidal thoughts, cold sensitivity, dizziness, cognitive defects, sleep disturbance, elevated liver enzymes, other autoimmune problems, and awkward gait.
Polymerase chain reaction (PCR) is a molecular biological tool used to produce many copies of a specific sequence of DNA.
PCR testing enables us to look directly for specific microbial DNA. Using this method, we can whether such microbes are present.
It is easier to collect urine than it is to draw blood. Also, urine is an excellent detection reservoir, since the urinary tract is known to be a place of spirochetal persistence (i.e., where spirochetes collect).
No, we do not offer either diagnoses or treatments in recommendations of any of our tests. If you require either a diagnosis or treatment, we encourage you to consult your primary care or Lyme-literate physician.
ADVANCED FAQ
The polymerase chain reaction, or PCR, is a molecular biology tool used to make many copies of a specific sequence of DNA, or in our case, genes specific to Borrelia Burgdorferi, the causative agent of Lyme Disease in the United States. PCR utilizes a machine called a thermal cycler to heat and cool the reaction in a controlled manner so that a target sequence is amplified. First DNA is denatured, or the double helix broken into two single strands, with a very high temperature. Then, primers anneal, or bind, to specific parts of the DNA sequence.
Once the primers have annealed, polymerase (the enzyme that replicates the DNA) fills in the other half of the single strand of DNA, making a copy of the original DNA fragment that was denatured. The number of target sequence is doubled with each cycle, leaving us with millions of copies of our target genes at the end of the process. Under optimal circumstances, only a single copy of the target region needs to be present in a given sample. In-house testing and statistical analysis have shown that our test is highly sensitive. In fact, we have shown that our testing can detect as few as ten organisms in a urine sample using PCR, and we can detect the presence of Borrelia Burgdorferi at similar, if not slightly higher, rates than can other known tests for Lyme.We also look for specific genetic variations that would give our clients a better understanding of their ability to handle the environment they live in.
Traditional tests for Lyme Disease look at the patient’s immunological response to having been exposed to an organism. This is an indirect method of testing. These tests are detecting antibodies against B. burgdorferi that are made by the human body when exposed to the organism. However, it is known that B. burgdorferi has evolved multiple mechanisms to evade the immune system’s responsiveness. Therefore, a test designed to gauge an immune response in a likely immune-compromised patient is inherently faulty.
The DNA Connexions Lyme Panel is a direct DNA test, designed to detect the DNA of the causative organism itself. Directly looking for the actual presence of the bacterial DNA itself means that neither the patient’s immune response nor the disease progression is material for drawing conclusions.
Sensitivity refers to a test’s capability to find a target gene or antibody if it is present. So, if you have 100 known positive patients and your test detects B. burgdorferi in 97 of those patients, your test has a sensitivity of 97 %. Specificity, meanwhile, refers to your test’s ability to definitively identify the molecular target with little to no chance that it could be a different target. Our sensitivity experiments showed our ability to detect as few as 10 organisms in a sample. We only use species-specific primers for our Lyme Panel, and we are continually working to ensure that we retain a high level of specificity as new organisms are discovered or current ones evolve.
We currently test for four specific B. burgdorferi genes and are working to add more targeted genes to our panel. Roughly 20% of patients that test with us test positive for the presence of B. burgdorferi. The national average for a positive test is between 10% and 20% with other testing methods. Less people show presence of co-infectors with our current panel, which is not surprising, considering that Lyme Borreliosis is the most common vector-born disease in the United States.
Our results in 2017 were in line with the national average for positive tests; that is, at around 20%. The current standard for Lyme Disease testing hasn’t changed in two decades. It’s not always easy to change people’s minds, but we are working hard to validate our test through continued evaluation and in-house research.
Many clinicians believe that exercise, infrared sauna, and deep tissue massage are good provocators of the microorganisms into the blood and then ultimately into the urine prior to urine collection. However, there are no university-based double blind studies published showing their efficacy. There is one study published by Drs. Klinghardt and Ruggiero (see reference below) that shows the use and efficacy of ultrasound used as a provocator. That having been said, we highly recommend patients to be physically active for at least 30 minutes before collecting their sample. This is because B. burgdorferi disseminates throughout the body and can hide in different places, such as the lymph nodes and joints.
Physical movement aids in releasing the organisms and getting them moving through the system, including the urinary tract. We also advise patients to void the bladder after activity or massage, to wait one hour, and then to collect the next urine for testing. Immediate collection after provocation may not allow enough time for a higher concentration of the organism to migrate to the urinary tract. If it has been a long time since the patient last urinated, a higher level of molecular debris may be in the sample, increasing the chance of a false negative. For this same reason, we do not advise collection of the first morning urine. It’s also important to provide a minimum sample volume of at least 30mL for our testing procedure. (cf. Klinghardt, Dietrich and Ruggiero, Marco, “The Ruggiero-Klinghardt (RK) Protocol for the Diagnosis and Treatment of Chronic Conditions with Particular Focus on Lyme Disease,” American Journal of Immunology, 2017.)
We do not advise patients on medical treatment for Lyme Disease. We have patients that test with us at multiple points in their Lyme Disease progression, and most of the time we have little or no information on antibiotic or other treatments that patients have received or are currently receiving. If patients have questions about the timing of their tests and/or treatments, they should consult a Lyme literate practitioner.
With antibody-based assays, the types of the antibodies present are different in the various stages of disease. For example, IgM antibodies are only clinically relevant in the very early stages of infection (after the bulls-eye rash, but within the first month), while IgG antibodies are clinically relevant with infections lasting more than 4 to 6 weeks. Theoretically, as soon as there is an active infection in the body, PCR should be able to detect the organism. In actuality, the timing of the process of dissemination, where B. burgdorferi all but leaves the blood stream and takes up residence in various sites of the body, varies greatly. The elevation of this process is different for every individual, and therefore, timing of DNA detection via PCR can vary.
Collection of urine is much easier on the patient than, for example, blood or cerebral spinal fluid collection. Also, urine collection can be done at home, painlessly, and at the patient’s convenience. The urinary tract is known to be a site of spirochetal persistence, which makes urine an excellent reservoir of detection.
Samples are processed in order of receipt, and results are dependent on how many samples we have in the lab at the time of receipt. Also, each sample must pass multiple levels of quality control. Patients can opt to rush their test for an additional fee. Provided that the sample passes quality control, those results are available in 7 working days. Non-rush test results can be expected in 12 to 21 working days.
The main organism is B. burgdorferi, the causative agent of Lyme Disease in the United States. Due to the evasive nature of this organism, we test for 4 species-specific regions of B. burgdorferi. The tick that most commonly carries B. burgdorferi can also be responsible for a multitude of other infections, called co-infections. We also test for several co-infectors, including several species of Babesia and Bartonella, two other Borrelia species, Ehrlichia chaffeensis, and Anaplasma phagocytophilium. We are constantly striving to broaden our Lyme Panel.
We chose the organisms on our current panel based on their relevance and prevalence during our research and development phase. We strongly believe that Bartonellosisand Babesiosis are under-studied and under-reported vector borne diseases (specifically Bartonella bacilliformis and Babesia divergens, the later of which is transmitted by a tick in the same family as the vector for Lyme disease).
There are certain regions of the country and the world where Lyme Disease is endemic. ‘Endemic’ means that there is always a certain level of persistence of a specific disease within a population. Since Lyme Disease is most commonly transmitted in the United States by the deer tick, areas with a high prevalence of deer ticks will see some persistent level of infection. For instance, according to the CDC, in 2015, 95% of confirmed Lyme Disease cases were reported in just 14 states: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and Wisconsin. We test patients from all over the world that suspect they have been infected by the Lyme Disease vector at some point. People today are very transient, so where someone lives doesn’t necessarily mean they have never been exposed. It just takes one tick bite, and as little as 20 minutes for the tick to transmit the pathogens it carries. It’s the same for any other vector-born pathogen, such as the various co-infectors we test.
We don’t necessarily know, but that doesn’t mean that the information is not valuable. Dead or living, a positive result still indicates the presence, whether now or in the past, of a potential infector. Our DNA purification method targets intracellular material from live cells. This means that we target live genetic material in the sample.
Yes, we’ve seen that happen. B. burgdorferi is known for it’s immune response evasion and being notoriously difficult to eradicate. There are some people that become infected and never even know because their immune system clears the infection on it’s own. Conversely, there are other patients that become severely and chronically ill in spite of multiple treatments and therapies. As far as going from positive to negative, this is likely the cause of a successful treatment. We have also seen cases where a robust B. burgdorferi infection could be inhibiting proliferation of a different organism. For example, we have seen patients who initially test positive for B. burgdorferi, undergo treatment, retest, and show a negative for B. burgdorferi, but then test positive for a co-infector, that was likely able to flourish with the clearing of an active B. burgdorferi infection.
While this is certainly a possibility, this is not currently a test we offer. There are other facilities specializing in the study of arthropod vectors that offer this kind of testing.
Most of our patients order this test through their doctor. At this time, patients also can directly request a collection kit at our Order Your Test Panel page. There, the test costs $650 USD, and a patient can opt to rush their sample for an additional fee of $150. We do not deal with insurance companies, but we encourage patients to communicate with their insurance carriers directly for possible coverage. The $650.00 fee does not include any of the interpretation, diagnosis, or recommended treatment that a Lyme literate physician would give you after interpreting the test results. Understandably, most physicians charge an additional fee for those services. We do not provide any consultations for patients.
Yes. We have seen individuals who are positive for co-infectors and not for B. burgdorferi.
NPS, or ‘non-predicted size,’ is a designation given to an amplification product which is larger or smaller than we expect. When we design the primers, we know the size of the target sequence that will be amplified. The genomes of these microbes are relatively small and replicate at a rate that leaves them prone to mutations (insertions, deletions, etc.). If a non-deleterious mutation occurs, meaning that it is a mutation that does not kill the organism, it can be propagated in future populations, and therefore the sizes of the amplification products can vary, though they are still from the same species. DNA sequencing of the amplification products has shown varying sized amplification products to be from the same targeted species. We have noticed a trend between chronic/long-term infections and NPS results.
The results of any molecular based test need to be taken into account with patient symptomology. Treatment protocols should be developed by a qualified physician.
We will update shortly.
Theoretically, with a 100% effective course of treatment, you should be able to test the effectiveness of a treatment within 2 weeks of the treatment conclusion. In the real world, however, it could take months or even years to completely clear all causative microbes. Initial testing establishes a baseline of microbial presence and/or disease, and subsequent testing is a reflection of treatment effectiveness.
DNA ConneXions can service most international locations. Depending on location, an international shipping fee will be applied to your cart upon checkout. If you wish to check in advance to ensure feasibility, please email info@dnaconnexions.com and provide the complete shipping address and our shipping department will make the determination if we can receive your sample back within our transport time frame.