We test for a range of flea and tick-borne pathogens. While we specialize in Bartonella, Borrelia, and Babesia we hope to add more tests for other complex infections in the near-future.
Getting tested with both direct and indirect detection methods provide a more comprehensive and accurate diagnosis, especially with infections and diseases that are difficult to detect.
Direct Detection:
Identifies the presence of the pathogen itself, such as with DNA, RNA, or proteins. Direct detection can confirm that the pathogen (parasite, bacteria, etc) is currently present in your body.
Indirect Detection:
Instead of identifying the presence of a pathogen, it looks for immune system responses to the pathogen. Most commonly, indirect tests are used to measure the level of antibodies in a sample. Antibodies are the proteins that the immune system typically produces to fight against antigens like bacteria or viruses. These tests can determine whether or not you have been exposed to a pathogen in the past, or even if your body is still fighting off an infection where it would be hard to detect the pathogen directly. Best for chronic or past infections in which pathogens are no longer detectable, but the immune response is.
The types of tests that we currently offer are all classified as laboratory-developed tests (LDTs) and offered as a clinical testing service. In the United States, LDTs are regulated under the Clinical Laboratory Improvement (CLIA) Program. Our lab is CLIA-accredited by COLA to ensure a rigorous quality control program and best lab practices. Please see our Quality Assurance page for licenses and additional detail.
The FDA currently regulates the sale and use of diagnostic products, including diagnostic test kits and in vitro diagnostic devices (IVDs) such as blood collection tubes, PCR machines, etc. The CDC does not regulate diagnostic tests but does make recommendations regarding the diagnostic standard of care for specific diseases based on published medical guidelines.
The BBB Direct Detect – Digital PCR is a direct detection DNA approach that is more sensitive than conventional detection methods. The test uses dPCR (digital PCR), an advanced form of polymerase chain reaction (PCR), which amplifies DNA after enriching the sample. This increases the likelihood of detecting the bacteria, even when present in very small quantities.
Which pathogens does the BBB detect?
The test requires whole blood which is put in a BAPGM liquid culture (Bartonella alpha Proteobacteria Growth Medium, BAPGM liquid culture is only for Bartonella detection) for 1 week. The sample is then divided into 13-26,000 partitions, and bacteria is amplified independently on each partition. The results are analyzed to determine how many partitions contain Bartonella, Borrelia, and/or Babesia spp DNA. The test functions on a genus-level, an approach that ensures that positive cases of infection with less common subspecies are not missed.
The Bartonella IgG Detect – IFA (Immunofluorescence Assay) is a serology test method that determines specified IgG antibodies circulating in a sample. As an indirect test method, it is used to determine past infection in a patient but may indicate present or active infection amongst high titer measurements. This method is especially useful when monitoring treatment response. Our test is validated for the four most common Bartonella species found in people (in the U.S).
Which species are detected?
The Lyme Borrelia Direct Detect – Nanotrap® is a direct detection test method that captures and concentrates OspA antigens to more accurately confirm a Lyme disease diagnosis. Nanotrap® particles capture and concentrate OspA proteins in urine samples. Nanotrap® particle sample enrichment greatly increases the likelihood of detecting these low abundance proteins. The test requires a minimum of 40ml of urine in a sterile container.
BBB Direct Detect can only be run with whole blood.
Lyme Borrelia Direct Detect – Nanotrap can only be run with urine.
Bartonella IgG Detect can only be run with serum.
Click below for specific information on sample collection.
The BBB Direct Detect may be performed on a single blood sample; or on a series of three blood samples drawn within a 5 to 8 day period. The 3 Day Draw is similar to the 1 Day Draw, except for the number of samples and when they were drawn (i.e. Day 1, Day 3, Day 5). Note: A 3 Day Draw cannot be run if all three samples are drawn on the same day. Samples must be drawn on different days.
The BBB can be run as a 1 Day Draw or a 3 Day Draw, and may also be bundled with other panels.
Bartonella species invade the endothelial cells that line the vascular system, cycling in and out of the blood over 5 to 8 days, evading the immune response in the bloodstream by hiding in erythrocytes and other cell types. Research suggests that a serial testing approach, which we call a 3 Day–or Triple Draw–may increase the odds of a positive dPCR result.
The triple draw was originally designed to increase detection for Bartonella, but interestingly, among the total Babesia-positive patients we’ve seen so far, those tested with the triple draw didn’t always show positivity on all three days—highlighting the added value of serial sampling in catching low parasitemia cases and the importance of concurrent draws when comparing methods. We strongly recommend this approach, especially when working with high clinical suspicion and a pathogen known to evade detection. The 3 collections days can be back to back days or spaced apart as long as all 3 are collected within 8 days. Once all 3 samples are collected – they are shipped together (Draw days 1 and 2 remain in the fridge according to specimen and handling instructions until draw day 3 is completed).
Nanotrap® particles capture and concentrate OspA proteins in urine samples followed by confirmation using a highly sensitive Western blot. Prior research shows that a small amount of OspA is detectable in the urine of Lyme disease patients. Nanotrap® particle capture and concentrate approach greatly increases the likelihood of detecting these low abundance proteins.
The Nanotrap® test is targeting the OspA protein, which can be found on the surface of Lyme Borrelia species belonging to both major groups (sensu stricto and sensu lato). The test will only determine if OspA is present, not which Borrelia species was detected.
Published data shows the Lyme Nanotrap® is very effective for confirmation of early-stage Lyme Borreliosis in patients with EM rashes (24/24). Galaxy validation data (unpublished) shows it is able to detect infection in patients with negative TTT results. Further research is needed to confirm clinical utility for other presentations of Lyme Borreliosis, including Lyme arthritis, Lyme carditis, and neuroborreliosis.
In one study of 100 post-treatment Lyme patients, 41% were still shedding Borrelia antigens—potential evidence of persistent infection.
Experts recommend combining direct detection test methods with indirect antibody testing to maximize the diagnostic data for low abundance infections, like Lyme Borreliosis.
Yes, a licensed medical practitioner (Licensed Physicians (MD, DO), NPs, PAs, and NDs with active NPI numbers) from an eligible state is required to order testing from Galaxy.
Galaxy Diagnostics is licensed in 49 states; New York is the only exception. If a NY provider is licensed in multiple states, it may be possible to order kits. Please call us for details.
We are not currently accepting orders directly from patients. NPI numbers are required when placing an order for kits, excluding international ordering providers. Galaxy Diagnostics must be able to verify an active license or certification for international practitioners without an NPI number.
Please contact us for a potential referral. We have a short list of healthcare providers who allow us to share their information for referrals. We will help where possible.
Yes! The ordering process is the same, but shipping involves a couple of extra steps and additional expenses since specimen collection kits cannot be shipped internationally. International shipping regulations require the inclusion of a commercial invoice and our CDC import permit. We handle international orders on a country-by-country basis to ensure timely arrival and secure chain of custody. Please e-mail [email protected] for more information, and see the International Ordering packet below:
Providers with an account can order kits online anytime on our website -> Order a kit.
All clinics/providers must register your practice with us first before placing a kit order. The provider may ship the kit directly to the patient’s address (excluding P.O boxes and New York residences), or to their clinic. Kits cannot be ordered from a New York clinic or shipped to a New York address.
Fill out the form on our website or call us for a guided experience. Shortly after a provider creates an account, a Galaxy team member will be in contact to assist with the ordering process. If a new provider has joined the practice, please contact us so we can add them to the account.
If you provider cannot perform the blood draw in the clinic, there are several other options. Local hospitals, draw center networks, and mobile phlebotomy services will often provide blood draws for a fee with a physician’s order and a specimen collection kit. If a patient with a test order needs help with locating phlebotomy options, please email [email protected] your zip code and we will reply with options page.
In the US, your provider can order a specimen collection kit which includes all the forms and materials required for collecting the sample and shipping the order overnight with an ice pack by Fedex. For more details, please see our Specimen Collection Form and Shipping Instructions.
If outside the US, please contact us or refer to our International Ordering packet.
Don’t panic. Most of the materials inside the kit are still usable. The expiration date on the kit indicates that at least one of the included tubes has expired. Please check the individual tubes before using them. If a tube is past its use date, it can be swapped out for standard SST tubes (yellow top, tiger top) and EDTA tubes (lavender top) as long as those tubes have not expired.
Any expired tubes will be rejected per CLIA regulations.
Samples may be rejected for the following reasons: Improper labeling of name or date of birth on specimen container, serum tube (SST yellow-top) is unspun, frozen cold pack missing, improperly stored, gross contamination, insufficient sample quantity, sample is damaged/leaking, serum is hemolyzed or lipemic, laboratory accident, missing information, courier delays, or sample received over holidays/weekends.
CLIA regulations require that each tube be clearly labeled with the patient’s name, date of birth, and collection date matching the completed Test Request Form. Missing or incorrect information may result in rejection of the sample for testing.
Before shipping, please review our Specimen Collection instructions and Shipping instructions to avoid possible rejection criteria.
If a specimen is rejected for any reason, the provider will be notified, and a new testing kit will be sent automatically for specimen recollection. Testing will resume once Galaxy receives the new specimen.
Orders may not be cancelled once the specimen collection kit has been shipped to Galaxy.
However, if a panel requires two specimen collection kits and only one has shipped, the test(s) related to the second specimen may be cancelled. In this case, Galaxy would test the specimen received and issue a refund related to the second specimen (refer to the Refund Policy for details).
The cancellation notice must be sent to [email protected] no later than 2 weeks from the date of the first shipment. After that date, cancellations are not accepted and no refunds will be issued.
Providers can access results as soon as they are available using our online results portal. They will be notified via email that results have been posted to the portal. Results can also be sent to providers via U.S mail or fax.
Patients must submit a results request form (either sent in samples or submitted after the fact) to receive a copy of the results directly, or to authorize sharing with another provider. Patients requesting results must have a secure fax number, or results will be sent via U.S Mail.
Test results cannot be e-mailed at this time due to HIPAA privacy/security regulations.
Turn around time is approximately 2 to 3 weeks.
BBB Direct Detect
With or without BAPGM™ sample enrichment, a positive dPCR result confirms the current presence of pathogen DNA.
Nanotrap® Results
The Lyme Borrelia Direct Detect test is a direct detection test method that also confirms the current presence of Lyme Borrelia antigen.
Serology IFA Results
In contrast, a positive serology result provides evidence of prior or current exposure to target infection but does not confirm the presence of the organism.
Some serology tests like IFA provide evidence of antibody titers (levels) which, when above a preset threshold, may be interpreted as an indication of the target infection. However, this standard is based on prior experience with acute, fast-growing infections and may not be representative of the pathobiology of later stage, slow-growing infections.
It is the provider’s job to interpret test results for a given patient. We provide a detailed test interpretation sheet with all reported results which provides general guidelines for interpretation. Please consult your doctor for a more specific interpretation regarding the importance for your specific case.
If you test positive we recommend retesting during and after treatment.
If you test negative please defer to your provider.
In infectious disease, a negative result does not rule out infection, especially for low level, hard-to-detect infections. While our sample enrichment methodology represents a significant gain in sensitivity and results in fewer false negative results; these pathogens are elusive and evade detection.
Serial testing and convalescent testing are common testing strategies to confirm and monitor low concentration infections, where detecting infection in a given test sample may be be difficult.
Prepayment is required for all orders; testing will not start until payment has been received in full.
Orders are billed as soon as possible once specimens arrive at the lab. Patients are responsible for submitting payment with their shipment. We will attempt to contact the patient via phone and/or e-mail if payment information is not included with the paperwork. If payment is missing or unable to be processed, an invoice will be emailed to the patient. The invoice must be paid within 7 days of receipt. *
Test result turnaround time may be delayed because of payment issues.
*Specimens typically expire after this time but may expire sooner depending on the collection date. Specimen recollection will be required if payment is not received prior to expiration.
We are not enrolled in any private or government insurance networks plans at this time. Pre-payment is required for all orders. Galaxy Diagnostics can provide a superbill for the patient to self-submit an insurance claim once testing is complete. If you have any questions concerning the billing process, please contact our business office at [email protected] or 919-313-9672.
We are not a Medicare or Medicaid provider at this time.
Insurance reimbursement rates vary by carrier and by your specific plan. You can request an estimate of coverage from your insurance provider in advance of ordering, using the test description and associated CPT codes. You can also self-submit a super bill once testing is complete.
You can file your own insurance claim for testing using the CPT codes and ICD-10 codes provided on our payment receipts for claims submission using a Galaxy Diagnostic’s provided superbill.
How to receive your superbill:
A superbill will be provided within 2-3 business days.
You can file your own insurance claim for testing using the CPT codes and ICD-10 codes provided on our payment receipts for claims submission using a Galaxy Diagnostic’s provided superbill.
How to receive your superbill:
A superbill will be provided within 2-3 business days.
Early diagnosis and prompt treatment are critical. The best odds of success for eradicating infection occurs when diagnosis and treatment of Lyme disease occur in the early stage of infection (first 4-6 weeks). Unfortunately, current antibody tests, like standard two-tier testing (STTT) lack sensitivity during early-stage infection. ELISA and Western blot are tests, or assays, used to detect antibodies made by the immune system against Borrelia burgdorferi, the bacteria that causes Lyme disease. Early after Borrelia species infections, many patients have not yet mounted an antibody response. Direct detection of the bacteria would circumvent this technical problem, as an antibody response is not required for detection.
Antibody tests are difficult to interpret both early and late in infection because antibody responses only provide evidence of pathogen exposure but do not provide direct evidence of active infection. Historically, direct detection of Lyme Borrelia has been difficult because the bacteria are low-yield pathogens that do not replicate to high numbers anywhere within the body and may only be present at 1 organism per 10 ml of blood. This low abundance makes direct detection by PCR-based amplification challenging, as there is a lot more host or background DNA than Borrelia DNA. Direct detection is like trying to detect a needle in a haystack. Blood also contains inhibitory substances that can interfere with PCR-based amplifications. The ability of Nanotrap particles to capture and concentrate small amounts of Borrelia antigen circumvents the limitations of both PCR and antibody testing.
Studies show that both mice and humans shed low numbers of Borrelia organisms and antigens into urine. Compared with blood draws, obtaining a urine sample is painless and non-invasive which can be a big advantage for children, the elderly, and those who dislike needles. Urine also has fewer inhibitory substances than blood that may interfere with detection of the target (protein or DNA).
Outer Surface Protein A is a Lyme Borrelia-specific protein that is expressed on the outer surface of the bacterial membrane. OspA is a tick adhesin – it allows Borrelia to stick to the midgut of ticks so that the bacteria remain inside the tick during feeding. As for other bacterial virulence proteins, Lyme Borrelia differentially regulate OspA expression to help “sense” the environment around them–inside a tick, animal host, or in culture medium, blood, tissue, etc.
Eurasian Lyme Borrelia species (senso lato) have different OspA serotypes from North American B. burgdorferi strains (senso stricto). The Nanotrap particles bind to a narrow C-terminal OspA protein domain conserved across strains/species within both complexes of B. burgdorferi.
This finding was nicely demonstrated in a 2015 publication from researchers at George Mason University (Magni et al 2015, J. Transl Med). As this paper was published prior to the discovery of Borrelia mayonii, this species was not included in their assessment. More research is needed to address utility of Nanotrap particle capture across newer species/strains.
Sample enrichment via antigen capture is necessary because B. burgdorferi organisms and their surface proteins are present at very low concentrations (i.e., 1 organism per 10 ml blood) in biological fluids, making direct detection a challenge (often called the “needle in a haystack conundrum”). Due to specialized chemistry, Nanotrap® particles have a specific affinity for OspA and will selectively bind to or “capture” it. High-speed centrifuges are then used to concentrate and recover OspA bound particles from large volumes of urine. Upon recovery, the resulting pellet is resuspended in a small volume of buffer for confirmation analyses.
The Nanotrap Urine Test is a direct detection test, so it provides direct evidence of an infection. The CDC standard two tier testing methodology and other antibody tests are indirect, as they measure antibody responses, which provide evidence of pathogen exposure but do not provide direct evidence of infection.
There is no single “magic bullet” test that accurately diagnoses every instance, symptom or circumstance of a stealth, chronic low-yield infection, like Lyme Borreliosis. A battery of tests is often needed and should contain a combination of indirect and direct test methodologies to adequately cover an expected disease spectrum within a diverse population.
Our internal validation data suggest that the Nanotrap Urine Test detects Lyme Borrelia in patients missed by standard two-tier testing. Conversely, there were also a subset of samples reactive by two-tier testing, but not positive by the Nanotrap Urine Test. Ongoing clinical utility studies will further delineate the specific disease stages and presentations best confirmed by the Nanotrap Urine Test. As we have in the past, we will share these findings through peer-reviewed publication.
Magni and colleagues (2015, J. Transl. Med) were able to utilize the Nanotrap® Urine Test to accurately detect Lyme Borrelia in 24 of 24 early, acute Lyme disease samples. Accurate detection was also achievable across a swath of samples obtained from small numbers of patients exhibiting various later-stage disease presentations. Larger, more expansive clinical utility studies will further delineate all the disease stages and presentations detectable with the Nanotrap Urine Test. We are working with academic research partners to conduct these studies now.
The most direct way to assess clinical utility is to test large numbers of defined, well-characterized samples belonging to each category (i.e., Lyme arthritis, Lyme carditis, neuroborreliosis) or population (i.e., acute, chronic, PTLDS) and compare the results obtained with the new test of interest (i.e., the Nanotrap Urine Test) to those obtained with the standard-of-care reference, standard two-tier antibody testing.
Ideally, testing would utilize paired samples encompassing multiple matrices of interest (whole blood, serum, urine, and tissue) and would also involve comparison to widely utilized and well-characterized direct detection test modalities, such as qPCR. Obtaining the number and diversity of sample types needed for a robust clinical utility study remains challenging for many vector-borne diseases, including Lyme Borreliosis.
