General
We test for a range of flea and tick-borne pathogens. While we specialize in Bartonella and Borrelia, we hope to add more tests for other vector-borne illnesses in the near-future.
- Bartonella, the bacteria responsible for Cat Scratch Disease
- Borrelia, the bacteria responsible for Lyme Disease
We also test for Babesia spp, Ehrlichia spp, Anaplasma spp, and Rickettsia spp on a Contract Research Only basis.
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 (virus, bacteria, etc) is currently present in your body. Best for acute infections, or cases where the pathogen is present in high enough quantities to be detected.
Methods: Nanotrap®, ePCR™, ddPCR, or PCR.
Indirect Detection:
Instead of identifying the presence pathogen, it looks for immune system responses that would happen when in the presence of the pathogen. Most commonly, indirect tests are used to measure the amount 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.
Methods: Serology, Western blot, and ELISA.
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 (the premier clinical laboratory accreditation, education and consultation organization) 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.
Our Tests
Currently only available for Bartonella species.
The Bartonella Digital ePCR™ is a direct detection DNA approach that is more sensitive than conventional detection methods. The test uses ePCR™ (enrichment 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.
Bartonella Digital ePCR™ options:
- 1 Day Draw
- 3 Day Draw
Both tests require whole blood which is put in a BAPGM liquid culture (Bartonella alpha Proteobacteria Growth Medium) for 1 week. The sample is then partitioned into thousands of tiny droplets through droplet digital PCR (ddPCR), and bacteria is amplified independently on each drop. The results are analyzed to determine how many droplets contain Bartonella DNA. The test functions on a genus-level, and will pick up on Bartonella species that may not be as common.
Immunofluorescence Assay serology is a test method that determines specified 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. The test requires serum that has been spun before shipment.
IFA Serology test options:
- 4-Species IFA panel (B. henselae, B. quintana, B. vinsonii berkhoffii, and B. koehlerae)
Each species can be ordered as a single test option if preferred.
The 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 followed by confirmation using a highly sensitive Western blot. Nanotrap® particle sample enrichment greatly increases the likelihood of detecting these low abundance proteins. The test requires 40-50 ml of urine in a sterile container.
ePCR™ can only be run with whole blood.
Nanotrap can only be run with urine.
IFA Serology can only be run with serum.
Click below for specific information on sample collection.
enrichmentPCR™
Bartonella Digital ePCR™ combines a sample enrichment step in our patented Bartonella Alpha Proteobacteria Growth Medium (BAPGM™) with genus-level ddPCR. BAPGM™ enrichment overcomes the challenges of low bacterial presence in clinical samples by supporting the growth these highly fastidious (hard-to-grow) bacteria up to detectable levels by ddPCR. Digital droplet PCR (ddPCR) greatly reduces the risk of false negative results by performing PCR on one test sample 20,000 times instead of once. This platform includes both pre- and post-culture ddPCR testing to ensure that non-viable as well as viable bacteria may be detected.
There are two ways to run this test platform:
- 1 Day Draw
- 3 Day Draw
Bartonella Digital ePCR™ may be performed on a single blood sample, or on a series of three blood samples drawn every other day 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.
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 ddPCR result.
There are two ways that labs measure test performance: sensitivity and specificity. Our Bartonella Digital ePCR™ platform is designed with genus level primers that pick up a broad range of Bartonella species. This approach ensures that positive cases of infection with less common Bartonella species are not missed. We combine a patented sample enrichment step (BAPGM™) with the most sensitive ddPCR available for low level infections.
Research shows that BAPGM™ sample enrichment followed by ddPCR significantly increases sensitivity by as much as 10x, allowing for earlier diagnosis of Bartonella species infection, especially in patients with no or low antibody titers. Importantly, PCR sensitivity varies by patient population and stage of infection (acute vs. chronic).
Galaxy Diagnostics holds an exclusive license to BAPGM™ from North Carolina State University, meaning this test platform is not available anywhere else.
Lyme Nanotrap®
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 sample enrichment 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 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 active 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.
Experts recommend combining direct detection test methods with indirect antibody testing to maximize the diagnostic data for low abundance infections, like Lyme borreliosis. We recommend ordering both the Nanotrap® Antigen Test and Two-Tier Testing (ELISA with reflex to Western blot) for confirmation of a Lyme disease diagnosis.
Ordering
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.
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.
Please email us, or fill out our ‘Find a Provider‘ form and a Galaxy team member will get back to you.
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 contact@galaxydx.com for more information.
Providers with an account can order kits online at Online Kit Request for Providers or by filling out our Kit Request Form and submitting by fax/email. You must create an account 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.
20 total kits can be ordered at a time for regular ground shipping. Rush shipping is limited to 1-2 kits and incurs a $60 fee that must be paid before the order is approved.
- Single Blood Draw Kit
- Triple Blood Draw Kit
- Urine Kit
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. Please see our blood draw services page for possible resources.
In the US, your provider can order a specimen collection kit which includes all of 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 for 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 it’s date then they 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.
Yes, a test cancellation request must be made within 36 hours of kit shipment and is subject to a $25 cancellation fee.
Each request must be accompanied by a completed Test Cancellation Request form and payment details. The form will be provided to you by the Customer Care team upon request.
Incomplete forms or requests received more than 36 hours after shipment will not be eligible for refunds.
Testing
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 with samples in order 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.
Results are typically released between 2-3 weeks. Each test has a slightly different work flow and turn around time, so feel free to contact us for an estimated timeline.
The Nanotrap® , IFA serology, and ddPCR test results can take up to 2 weeks. Bartonella Digital ePCR™ takes up to 3 weeks due to the 1-week incubation period required for BAPGM™ sample enrichment.
Tests cannot be expedited, so please reach out to our Customer Care team for any questions before ordering.
ePCR, ddPCR, & PCR Results
With or without BAPGM™ sample enrichment, a positive ddPCR or PCR result provides confirmation of active infection.
Nanotrap® Results
The Lyme Nanotrap test is a direct detection test method that also confirms active infection.
Serology 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.
How can I better understand my results?
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.
To best support our healthcare provider clients, we can refer you to a doctor who offers clinical consultations for a fee.
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 Bartonella Digital ePCR™ using BAPGM™ enrichment represents a significant gain in sensitivity and results in fewer false negative results; these intracellular bacteria are elusive and evade detection.
Serial testing and convalescent testing are common testing strategies to confirm and monitor low concentration infections, where confirming infection in a given test sample maybe be difficult.
Billing
Pre-payment by personal check, money order, VISA, MasterCard American Express or Discover is required for all test orders. Payment is processed once we receive an order and ensure that all samples are suitable for testing.
We will attempt to contact the patient via phone and/or e-mail if payment information is not included with the paperwork. The order will still begin processing, but results will not be reported until payment information is received. Orders that are complete but have results being held due to a payment issue will be reported 1-2 business days after the issue is resolved.
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 (send requests to superbill@galaxydx.com) 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 contact@galaxydx.com 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:
- Send an email request to superbill@galaxydx.com
- Include the patient’s name, date of birth, testing ordered, and date of service.
A superbill will be provided within 2-3 business days.
We do not normally offer discounts to patients. We invest every extra penny into clinical research to further advance diagnostic testing and to clarify the clinical importance of various infections for chronic disease. Less for us means less funding for R&D. That said, we do consider hardship cases presented by providers with a high clinical suspicion of the involvement of flea/tick-borne infection. These situations are considered on a case-by-case basis. We can also work with patients on payment plans when needed. For more information, please e-mail contact@galaxydx.com.