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 this new 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 this 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 time period increases the sensitivity of Bartonella detection. Bartonella reside in the cells that line blood vessels, and enter into 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. The NCSU Bartonella research team relies exclusively on the Triple Draw collection method for research purposes.
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.
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 bacteria 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.
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. Please contact us for further details.
How many species of Bartonella are there?
There are over 25 named species of Bartonella, of these about 17 have been associated with a wide spectrum of human diseases, most of them zoonotic. Bartonella henselae is the most common Bartonella species detected in our lab.
Are your laboratory tests approved by the FDA or CDC?
We offer laboratory-developed tests (LDTs) as a service, which are not currently regulated by the FDA or by CDC. The FDA currently regulates the sale and use of diagnostic test kits and in vitro diagnostic devices (IVDs), like 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 Program (CLIA) by COLA. We outsource DNA sequencing to an accredited service provider. Please see our Quality Assurance Statement for licenses and additional detail.
How much do the tests cost?
How does billing and insurance work for the cost of testing?
We can set up institutional accounts, bill physicians’ offices directly, or direct bill the patient. Prepayment by credit card is required for all direct billing patient arrangements. We will file an insurance claim for human health testing that will reimburse the patient according to the policy benefit. 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 Bartonella Test Descriptions for Human Health. For your convenience, CPT codes are also provided on our payment receipts for claims submission purposes.
Do I need a doctor to order this testing?
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. We currently do not have a referral list of doctors.
What states are you currently offering testing in?
Galaxy is approved for testing samples from all U.S. states except NY (in process).
How do I order sample kits?
Please fill out a Kit Order Form and submit it to us by fax/email.
How do I send my samples to your lab?
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. Contact us for details.
How long is the testing process, and when can I expect my results?
Final test results can take up to 3 weeks, due to the patented BAPGM process.
How can I better understand my results?
We provide a detailed test interpretation sheet with all reported results.