The most sensitive test method available for direct detection of Bartonella, Babesia, and Borrelia spp infections.
These elusive pathogens often evade immune response and direct detection by hiding in cells and tissue. Many patients with detectable spp DNA never develop detectable antibodies, while others may only show very low titers. The result is many patients with active infection are missed by both conventional DNA and antibody testing.
Our solution is BBB Direct Detect multiplex, a DNA detection approach that increases the number of patients confirmed by up to 6 times compared to conventional detection methods, like qPCR, NGS, and other direct detection methods. Originally developed and used by North Carolina State University’s College of Veterinary Medicine, this advanced digital PCR (dPCR) assay has been instrumental in driving clinical discovery, uncovering previously underappreciated associations between Bartonella, Babesia, Borrelia, and chronic illness.
We use genus level primers in our lab that are designed to pick up a broad range of Bartonella, Borrelia, and Babesia species. This approach ensures that positive cases of infection with less common species are not missed.
How the Test Works
The BBB Direct Detect requires 5 ml of whole blood which is put into BAPGM liquid culture for one week. Bartonella-specific detection is enhanced through a one-week enrichment in BAPGM liquid culture, followed by digital PCR (dPCR) for precise spp identification. Borrelia and Babesia are identified directly from whole blood using the same cutting-edge dPCR technology, delivering comprehensive results in a single test run.
Our Bartonella approach can confirm up to 6x more infected patients than standard qPCR (n=38 high risk patients), supporting earlier diagnosis of infection.
Traditional testing methods may miss active infections due to low pathogen levels or antibody variability. Our multiplex addresses these challenges by combining two revolutionary technologies:
- Digital PCR (dPCR): Looking for microbial DNA in a blood sample is like looking for a need in a haystack. Conventional direct detection techniques often miss confirmation of low abundance pathogens due to inhibitory factors, like host DNA, that are also present. Digital PCR technologies overcome this limitation by partitioning the sample into ~20,000 droplets and performing a PCR reaction on each droplet. Based on our SBIR-funded research, this powerful technology increases the sensitivity of PCR detection by as much as 10 times.
- Bartonella Proprietary Sample Enrichment: Bartonella species are often able to evade detection by even the most sensitive test methods due to the low abundance of organisms present in blood samples. Utilizing our patented Bartonella Alpha Proteobacteria Growth Medium (BAPGM), we culture portions of the blood sample to amplify the bacterial load, enhancing detectability. This sample enrichment step increases the bacterial load in patient samples up to detectable levels for dPCR testing.
Test Recommendations
➜ Order BBB Direct Detect + Bartonella IgG Detect IFA
Along with a growing community of medical researchers worldwide, we recommend maximizing diagnostic data by testing for both antibodies and DNA evidence of infection, as each test provides critical support. Combining direct and indirect testing methods–specifically for Bartonella infection–enhances diagnostic accuracy, especially for patients with complex clinical presentations. Indirect methods, like serology tests, detect antibodies that indicate exposure to the pathogen, backing up a direct detection result.
➜ Order BBB Direct Detect + Lyme Borrelia Direct Detect
At Galaxy, we recommend the Lyme Borrelia (Nanotrap) Direct Detect assessing the current presence of a Borrelia infection. Concentrations of Lyme Borrelia are so low in the blood that a blood draw is unlikely to capture the pathogen in the test tube.
Why include Borrelia in the BBB assay? While the species associated with Lyme Borrelia often hide in tissues and don’t free-circulate in high copy numbers in blood, the species associated with Relapsing Fever Borrelia do replicate to high numbers in the blood.
As a result, combining the BBB assay with the Nanotrap® urine antigen test for Lyme provides optimal coverage for the top flea and tick-borne infections at the genus level.
FAQS
What is the recommended use of this test?
For newly infected patients, we recommend testing for both DNA and antibody evidence. For patients who have failed treatment or who have recently undergone aggressive antibiotic therapy, direct detection using this platform may not be as helpful.
Is Triple Draw testing still recommended?
Prior research suggests that serial testing on three samples collected in a one week period can increase the odds of confirming a positive case of Bartonella species infection. Future studies are required to quantify potential gains of serial testing for this more sensitive BBB Direct Detect 3 Day Draw.
Which species are detected?
The BBB Direct Detect platform will only confirm whether species of Bartonella, Babesia, and Borrelia were detected or not. As the test was validated on a genus-level, it will not differentiate between species. A genus-level approach ensures that positive cases of infection with less common species are not missed by more species-specific tests.
Does this test method confirm active infection?
Yes, a positive result indicates an active infection. However, the determination of whether the presence of the organism is causing the patient’s symptoms is up to the clinician.
