Our Laboratory Director is a CLIA-qualified High Complexity Laboratory Director, with a PhD in Immunology, a BS in Medical Technology, a MS in Biology, over 20 years of high complexity laboratory testing experience and 17 years as a CLIA-qualified High Complexity Laboratory Director. Our Medical Advisors include experts in diagnosis and treatment of borreliosis, bartonelloses, and other hard to diagnose infections. Our minimum educational standard for laboratory personnel is either MLT certification or a BS in a laboratory science and all personnel are formally trained on Standard Operating Procedures, Blood-borne Pathogens/Laboratory Safety, Patient Confidentiality, and Quality Assurance Procedures regarding sample handling, processing, and reporting.
Our laboratory and equipment are maintained according to COLA/CLIA standards, including temperature and humidity monitoring, routine calibration of instruments and equipment, the use of biosafety cabinets for microbial culture, and use of dedicated PCR hoods for pre- and post-PCR processing.
To establish the performance characteristics of each CLIA-validated assay, we assess test accuracy and precision and measure both analytical and clinical sensitivity and specificity. Our test methods are classified as “validated in house” following standards set by CLIA regulations and other best practice standards in molecular microbiology and immunology: (1) ongoing documentation of internal or inter- laboratory performance using known reference standards for the species and/or diagnostic specimens of interest; (2) publication of novel methods in a peer-reviewed journal with sufficient documentation to establish diagnostic performance and interpretation of results; and (3) documentation of internal or inter-laboratory comparison to an accepted methodology or protocol.
Digital PCR Culture (BAPGMTM Enrichment using dPCR)
In order to pre-enrich samples for Bartonella species, we use a novel enrichment medium called Bartonella alpha- Proteobacteria Growth Medium (BAPGMTM), developed and described in peer-reviewed literature by researchers with an established global expertise in the field of emerging vector-borne disease, most notably Bartonella spp infection, at North Carolina State University College of Veterinary Medicine. BAPGMTM serves as the foundation for a novel testing platform which combines enrichment culture with pre- and post-culture dPCR testing for confirmation of infection. This novel test platform provides enhanced detection of Bartonella DNA missed by conventional PCR detection methods and is currently the most effective means of Bartonella spp. DNA detection offered anywhere in the world. Cultured Bartonella organisms are used for culture positive standards and for extraction controls. Quality assurance for BAPGMTM liquid culture is verified for each test run by consistent use of both positive and negative control samples in addition to positive and negative controls for dPCR.
Digital PCR (dPCR)
Validated diagnostic dPCR assays currently offered include those for genus-level detection of Bartonella, Borrelia, and Babesia species. This technology offers highly sensitive direct detection of low-abundance, slow-growing microorganism DNA through sample partitioning. Test samples are processed into 26,000 partitions prior to performing PCR on each, reducing inhibition from host DNA. Quality assurance for dPCR is verified with each testing run by consistent use of standardized, qualified positive control samples for each pathogen and negative control samples including no template controls and naive human blood DNA samples.
Borrelia Nanotrap® Antigen Test
The Nanotrap® Antigen Test is an enhanced direct detection method that confirms the presence of Lyme Borrelia pathogen within human urine samples. Nanotrap® particles (manufactured by Ceres Nanosciences) capture and concentrate the Borrelia OspA antigen shed within urine prior to confirmation using a highly sensitive Western blot. Cultured Borrelia organisms are used to generate standardized positive control samples. Quality assurance for Nanotrap® particle performance is verified for each test run by consistent use of standardized, qualified positive and negative control samples.
Bartonella Serology
Indirect immunofluorescence assay (IFA) testing for bartonellosis determines the presence or absence of antibodies to a single Bartonella species within human serum. Clinically, measured antibody levels are generally considered to be indicative of an individual’s prior or current immune response against a specific pathogen. The presence of antibodies indicates that a patient has been exposed to a particular species of Bartonella. IFA serology tests have been approved as a useful tool for identifying patient exposure to B. henselae, B. quintana, B. vinsonii berkhoffii, and B. koehlerae. Quality assurance for B. henselae, B. quintana, B. vinsonii berkhoffii, and B. koehlerae IgG IFA performance is verified for each test run by consistent use of standardized, qualified positive and negative control serum samples.
For questions, please contact the lab at 919-313-9672 or email [email protected].
