Tests
What organisms do you test for, and what kind of tests are they?
- Digital ePCR™ (BAPGM™ sample enrichment combined with ddPCR)
- ddPCR
- PCR
- IFA serology (B. henselae, B. quintana, B. vinsonii berkhoffii, B. koehlerae)
- ELISA
- Western blot
- Nanotrap® Urine Test
- PCR
- PCR
- PCR
- PCR
What is a PCR?
PCR (polymerase chain reaction) is a molecular method used to detect DNA in patient samples. This test is used to detect active infection.
What is serology?
Serology includes IFA (immunoflurescence assay), ELISA (enzyme-linked immunosorbent assay), and Western blot (immunoblot), all of which are designed to detect antibodies in patient samples. This test is used to detect past infection in a patient. A high titer (measurement of immune response) may indicate active infection as well.
How does the Bartonella Digital ePCR™ test work?
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.
Why is your Bartonella Digital ePCR™ test platform better than other tests?
The primary diagnostic challenge for Bartonella infection is that these intracellular bacteria infect at very low levels, cycling in and out of the blood over 5-7 days, and evading immune response and molecular detection by hiding in cells. The result of this pathobiology is a very high false negative rate for both molecular and conventional antibody testing. We overcome this challenge by combining a patented sample enrichment step with the most sensitive ddPCR available for low level infections.
Galaxy Diagnostics holds an exclusive license to BAPGM™ from North Carolina State University, meaning this test platform is not available anywhere else.
We recommend that Bartonella Digital ePCR™ be ordered along with Bartonella IFA serology panel to maximize clinical data, especially for baseline testing and first orders.
How accurate is your Bartonella Digital ePCR™ test platform?
There are two ways that labs measure test performance: sensitivity and specificity. Our Bartonella Digital ePCR™ platform is designed to be sensitive across a broad range of Bartonella species.
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).
Please contact us for a list of publications that illustrate the increased sensitivity.
Single Draw vs. Triple Draw: which one should I pick?
Bartonella Digital ePCR™ may be performed on a single blood sample drawn on Day 1 or on a series of three blood samples drawn every other day within a 5-7 day period (Day 1, Day 3, Day 5). Bartonella species invade the endothelial cells that line the vascular system, cycling in and out of the blood over 5-7 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 Triple Draw, may increase the odds of a positive ddPCR result.
What sample types can be used for Bartonella Digital ePCR™?
We can test a range of different sample types by ddPCR and qPCR, including joint fluid, cerebrospinal fluid, pericardial effusions and lymph node aspirates, fresh/frozen tissue, and paraffin-embedded tissue. Please note that BAPGM™ enrichment culture can only be performed on fresh specimens. Testing for many non-blood specimens may not be supported by a full validation with clear performance characteristics defined by testing on a large number of samples. These tests are described as RUO (Research Use Only) and caution is advised when interpreting these results. Click below for specific information for tissue and fluid collection.
How does the Lyme Borrelia Nanotrap® Antigen Test work?
Nanotrap® particles capture and concentrate OspA 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.
Are your laboratory tests approved by the FDA or CDC?
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.
How to Order
Do I need a doctor to order this testing?
Yes, a licensed medical practitioner from an eligible state is required to order testing from Galaxy. If you are a patient, please talk to your medical practitioner about ordering a Bartonella test. NPI numbers are required when placing an order for kits. Galaxy Diagnostics is licensed in 49 states; New York is the only exception.
Who is considered a licensed healthcare practitioner?
Licensed Physicians (MD, DO), NPs, PAs, and NDs with active NPI numbers.
How do I order sample kits?
Providers can order kits online at Online Kit Request for Providers or by filling out our Kit Request Form and submitting by fax/email. NPI numbers are required when placing an order for kits.
Which specimen collection kit should I order?
We offer different sample collection kits depending on the sample type to be tested: blood, urine, and tissue/non-blood fluid.
Can patients order kits?
Only licensed healthcare providers can order specimen collection kits. We are not currently accepting orders directly from patients.
What states are you currently offering testing in?
Galaxy is approved for testing samples from all U.S. states, except New York.
Do you accept orders from outside the United States?
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.
Billing and Insurance claims
How much do the tests cost?
Please see the Test Pricing sheet on our website.
When do I pay?
Pre-payment by personal check, money order, VISA, MasterCard American Express or Discover is required for all test orders, except Medicare patients. Payment is processed once we receive an order and ensure that all samples are suitable for testing. See our Insurance & Billing guidance for more information.
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.
Do you accept insurance?
We are not enrolled in any private insurance networks at this time. Pre-payment is required for all orders except Medicare. With completed insurance/billing form including front and back copies of your insurance card and valid photo ID, we file an insurance claim on behalf of the patient once testing is complete.
We are not able to file insurance for tests that are self-pay only.
Do you accept Medicaid?
We are not a Medicaid provider at this time.
Do you accept Medicare?
Yes, we do accept Medicare. While prepayment is not required for Medicare orders, a signed Advanced Beneficiary Notice (ABN) must be submitted with the order in order for testing to proceed. Importantly, patients are responsible for the full cost of testing in the event of a denied Medicare claim. The most common reason we see for denial is when the ordering physician is not enrolled under the right Medicare designation. Please see Insurance and billing for more information.
How much will my insurance provider reimburse?
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 on our Test Pricing form.
Can I file my own insurance claim?
Yes, if you prefer, 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. Duplicate claims will be likely denied.
Do you offer discounts?
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.
There are also organizations that offer financial assistance to tick-borne disease patients and families. More information can be found on our patient resources page.
Specimen collection
How do I send my samples to your lab?
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.
Do serum tubes (SST, gold top, tiger top, etc.) need to be spun down in a centrifuge prior to shipping?
Yes, all serum samples collected in a serum separator tube (SST) require a period of rest followed by centrifugation to avoid hemolysis of the sample. Detailed sample collection instructions for serum samples are included on our Specimen Collection Form. Unspun samples will be rejected for testing as the quality of the specimen will not be suitable for testing.
My doctor sent me a kit. Where can I go to get my blood drawn?
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.
What information should be written on the sample collection tube?
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.
Am I able to use my own test tubes?
Yes, providers may use their own standard SST tubes (yellow top, tiger top) and EDTA tubes (lavender top) as long as the tubes have not expired . Please email contact@galaxydx.com if you have questions.
Test Results, Interpretation and Treatment
How long is the testing process, and when can I expect my results?
Nanotrap® , 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.
For the Borrelia burgdorferi (Lyme disease) reflex panel, ELISA results will be sent out within 2 weeks from the day samples are received. If the ELISA result is positive/equivocal, the Western Blot results will be reported within 3 weeks from the day the samples are received.
Can patients receive results directly?
Yes, please complete and email/fax a completed Patient Results Request Form to request a copy of your results or to authorize sharing with another provider.
Can results be sent by email?
No, HIPAA regulations currently prohibit us from sending results to providers or patients by unencrypted email. However, providers can download results using our online provider portal following email notification when results are posted.
What does a positive PCR, ddPCR, or Digital ePCR™ test result tell you? What about a positive serology result?
With or without BAPGM™ sample enrichment, a positive ddPCR or PCR result provides confirmation of active infection. The Nanotrap® antigen test is a direct detection test method that also confirms active infection.
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.
I tested positive for Bartonella. Should I get retested after treatment?
Yes, we recommend retesting during and after treatment. Please contact us if you have questions.
I tested negative for Bartonella with the Bartonella Digital ePCR™ test panel. Do you recommend retesting?
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.
Do you have a referral list of doctors?
We have a short list of healthcare providers who allow us to share their information for referrals. Please e-mail contact@galaxydx.com and we will help where possible.
