Untargeted Test for Targeted Treatment Plans
Tickborne diseases, such as Lyme disease, present unique challenges to accurate identification and targeted treatment. Targeted antibody tests often give false or confusing results, and symptoms are inconstant and influenced by co-infections.
CSI-Dx™ removes the guesswork by providing solid evidence of active infections and co-infections by identifying RNA and qualitatively reporting on all detected infections. Additionally, we provide more detail breaking down the percentage of each pathogen found within a urine sample. By using RNA instead of just DNA, we focus only on the pathogens and genetic code that carries the biomarker for life and ignore non-contributing cells.
How It Works
Patient supplies a urine sample which is mailed to the lab.
Wet Lab Processing
The sample undergoes CSI’s proprietary bacterial amplification technique and RNA extraction. At this stage, we detect any active genetic code present in the sample and weed out non-active code that could confuse the results.
After returning the RNA code to a stable DNA equivalent (reverse transcription), the sample is sequenced and streamed directly into our in-house, proprietary curated database for cutting-edge response time and accuracy. The results show only active pathogens and active antibiotic resistance.
All data is analyzed and filtered through our proprietary bioinformatic database. Reports are reviewed by our qualified lab director for verification before finalized reports are sent.
Within 24 hours, a report is automatically sent to a physician’s Electronic Medical Records (EMR) system or faxed to the medical office. The report details the presence or absence of tick-borne pathogens, with a limit of detection of only 3 pathogenic cells per milliliter of urine, giving physicians actionable data for diagnosis and treatment decisions.
What We Test For
The CSI-Dx™ test utilizes Next Generation Sequencing (NGS) technology and CSI’s validated RAPID-Dx™ analysis pipeline to directly detect microbial DNA and RNA in urine from active bacteria, fungi, viruses, and protozoa. CSI-Dx™ can simultaneously detect 43 unique tickborne-associated pathogens in a single sample, with a database that is comprised of over 500 pathogenic genomes. Sequencing of nucleic acids directly from clinical samples has allowed for the detection of a wide array of pathogens and circumvents many of the limitations seen in previous methods of diagnostics such as culture or PCR.
The CSI-Dx™ test has been analytically validated to report the presence of pathogenic microbial nucleic acid when present at levels above each microbe’s established Limit of Detection (LOD). The results included within the report display all tick-borne associated microbes that yielded normalized sequence counts in the clinical sample. Microbes that yield normalized sequence counts above their analytically validated LOD are considered to be detected, whereas species that yield normalized RNA sequence counts below the LOD are considered to be incidental findings.