Tests

What organisms do you test for, and what kind of tests are they?

Bartonella

  • ePCR – see description below
  • IFA serology

Borrelia burgdorferi

  • ELISA serology
  • Western blot serology

Piroplasma (Babesia/Theileria)

  • PCR

Anaplasma

  • PCR

Ehrlichia

  • PCR

Rickettsia

  • PCR

What is a PCR?

PCR (polymerase chain reaction) is a molecular method used to detect DNA in patient samples.

What is serology?

Serology includes IFA (indirect fluorescent antibody), ELISA (enzyme-linked immunosorbent assay), and Western blot, all of which are designed to detect antibodies in patient samples.

How does the Bartonella ePCR™ test work?

Bartonella enrichmentPCR (ePCR™) combines an enrichment culture step in our patented Bartonella Alpha Proteobacteria Growth Medium (BAPGM). The BAPGM enrichment culture step provides the ideal growth environment for Bartonella, allowing these fastidious (hard-to-grow) bacteria to grow to detectable levels by PCR. Our test platform includes both pre- and post-culture PCR testing to ensure that non-viable as well as viable bacteria may be detected.

Why is your Bartonella test better than other tests?

Conventional Bartonella tests suffer from very high rates of false negative results, due to the low numbers of bacteria or antibodies found in a sample. Our advanced Bartonella detection system overcomes this false negative problem by combining our patented BAPGM step with proprietary PCR testing to increase the number of bacteria in a given sample. Galaxy Diagnostics holds an exclusive license on the patented enrichment culture from North Carolina State University, so this new test is not available anywhere else.

How sensitive is your Bartonella test compared to others?

In general, our Bartonella ePCR test is 10 times more sensitive than a basic Bartonella PCR test and, unlike a Bartonella henselae serology test, confirms active infection. Please see our Test Performance statement for more information.

How accurate is your test at detecting Bartonella?

The diagnostic specificity of our Bartonella ePCR is approximately 99% or more. We use genus-level primers that work well for a broad number of Bartonella species, and we sequence verify every positive PCR result to confirm the species of infection.

Single Draw vs. Triple Draw: which one should I pick?

Our basic test involves the collection of one sample. We call this a Single Draw.

The Triple Draw includes three blood sample sets (whole blood & serum) drawn over the course of a 7-8 day period (e.g., M-W-F). Research shows that testing multiple samples drawn over the course of this period increases the sensitivity of Bartonella detection. Bartonella reside in the cells that line blood vessels and enter the bloodstream at cyclical intervals. The Triple Draw collection method increases the odds of collecting a sample with a higher bacterial load, to increase the likelihood of detection.

What samples do you test for besides blood?

In addition to blood, we can also test fresh/frozen tissue, joint fluid, cerebrospinal fluid, pericardial effusions and lymph node aspirates. We can also perform Bartonella PCR on paraffin-embedded tissue. Testing for specimens other than blood are not currently validated in our lab by a regulatory agency; results will be reported as RUO (Research Use Only) and should not be used for diagnostic purposes. Click below for specific information for tissue and fluid collection.

Tissue and fluid collection

Are your laboratory tests approved by the FDA or CDC?

We offer laboratory-developed tests (LDTs) as a service. These tests are not currently regulated by the FDA or the CDC. The FDA currently regulates the sale and use of diagnostic test kits and in vitro diagnostic devices (IVDs), such as blood collection tubes, PCR machines, etc. The CDC does not regulate tests but does make recommendations regarding the diagnostic standard of care for specific disease areas.
Following federal regulations, our laboratory operations are accredited under the Clinical Laboratory Improvement (CLIA) Program by COLA. We outsource DNA sequencing to an accredited service provider. Please see our Quality Assurance page for licenses and additional detail.


How to Order

Do I need a doctor to order this testing?

Yes, any licensed medical practitioner from an eligible state can order testing from Galaxy. If you are a patient, please talk to your medical practitioner about ordering a Bartonella test. NPI numbers are required to be submitted by practitioners when placing an order for kits.

Who is considered a licensed healthcare practitioner?

Licensed Physicians (MD, DO), NPs and NDs with active NPI numbers.

How do I order sample kits?

Physicians can order kits online at Online Kit Request for Providers or by filling out our Kit Request Form and submitting it to us by fax/email.

Can patients order kits?

Only licensed healthcare providers can order 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 (in process).

Do you accept orders from outside the United States?

Yes. The ordering process is the same, but shipping instructions involve a couple of extra steps. 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. Please email us for more information at contact@galaxydx.com.


Billing and Insurance claims

How much do the tests cost?

List prices are shown here: Test Pricing.

When do I pay?

Prepayment by personal check, money order, VISA, MasterCard American Express or Discover is required for all testing, excluding Medicare (see Insurance & Billing for more information on sample submission for Medicare patients).

Do you accept insurance?

Pre-payment is required; however, we will file an insurance claim on the patient’s behalf once testing is complete.

How much will my insurance provider reimburse?

Insurance reimbursement rates vary by carrier. If you would like to check with your insurance provider for coverage in advance of ordering, you can find the relevant CPT codes on our Test Pricing form.

Can I file my own insurance claim?

You can file your own insurance claim for testing. If you wish to do so,  CPT codes are provided on our payment receipts for claims submission.


Specimen collection

How do I send my samples to your lab?

Detailed sample collection and shipping instructions are included on our Specimen Collection Form and Shipping Instructions forms.

Serum is needed for the test I am ordering. Does this sample need to be spun down in a centrifuge?

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.

What information should be written on the sample collection tube?

Name, date of birth and collection date matching the test request form must be noted on each sample collection tube submitted for testing. Missing or incorrect information may result in rejection of the sample for testing.


Test Results, Interpretation and Treatment

How long is the testing process, and when can I expect my results?

Bartonella ePCR is 3 weeks, due to the patented BAPGM process. All serology tests and PCR for other vector-borne organisms are 2 weeks.

Can patients receive results directly?

Yes, for patients to receive results directly, please fill out the attached Patient Results Request Form and return it to Galaxy by fax or mail.

Can results be sent by email?

No, regulations currently prohibit us from sending results to providers or patients by email.

How can I better understand my results?

We provide a detailed test interpretation sheet with all reported results. Click the links below to view interpretations for each test.

Bartonella ePCR Test Interpretation

Tick Panel PCR Test Interpretation

Bartonella IFA Test Interpretation

Borrelia (Lyme) ELISA Test Interpretation

Borrelia (Lyme) Western blot Test Interpretation

I tested positive for Bartonella. Should I get retested after treatment?

Yes, we do recommend periodic retesting for treatment follow-up. Please see our recommended Bartonella Test Protocol for details and discuss with your healthcare provider.

I tested negative for Bartonella with the Bartonella ePCR™ test. Do you recommend retesting?

Failure to detect Bartonella in a patient sample does not rule out infection. Bartonella ePCR™ was designed to reduce false-negative results; however, this bacterium is elusive and infects different parts of the body at very low levels. Repeat testing prior to and/or after initiation of antibiotic therapy may be necessary to detect the bacterium.

Do you have a referral list of doctors?

We currently do not have a referral list of doctors.