Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Lyme Disease
Science Leader in the Testing of Flea and Tick Borne Illness Introduces the Nanotrap® Urine Test for Lyme Borreliosis
News provided by
Galaxy Diagnostics, Inc.
Nov 10, 2020, 09:01 ET
DURHAM, N.C., Nov. 10, 2020 /PRNewswire/ -- Galaxy Diagnostics, Inc., the science leader in sample enrichment powered testing solutions for elusive flea and tick-borne pathogens, today announced the launch of the Nanotrap® Urine Test for Lyme Borreliosis. This urine-based Lyme antigen test provides the most sensitive direct detection of Borrelia burgdorferi infection at all stages of the disease. The test provides advantages antibody testing does not, namely:
The revolutionary test greatly increases the likelihood of Lyme disease confirmation via innovative Nanotrap® technology developed by Ceres Nanosciences. Nanotrap® particles capture and concentrate low abundance Outer surface protein A (OspA) in urine samples confirmed by a highly sensitive Western blot.
- Identifies positive cases missed by CDC-recommended Two-Tiered Testing (TTT)
- Reduces concern for false positive results via direct detection of OspA proteins
- Uses easy-to-collect urine sample
Published data shows that the Nanotrap Urine Test is very effective for confirmation of early stage Lyme borreliosis in patients with EM rashes (24/24). Galaxy validation data (unpublished) shows that the Nanotrap® Urine Test will often confirm active infection in patients with negative TTT results. Further research is needed to confirm clinical utility for other presentations of Lyme borreliosis, including Lyme arthritis, Lyme carditis, and neuroborreliosis.
"The addition of the Nanotrap® test aligns with our mission to bring the most scientifically advanced, most sensitive and most accurate sample enrichment testing to the forefront of flea and tick borne disease", said Galaxy CEO Amanda Elam. "Lyme disease is the fastest growing tick-borne illness in the United States. We are committed to improving the standard of care around detection of these elusive, underlying pathogens to catalyze improved clinical protocols for millions of patients globally."
Galaxy advocates for a new standard of care in Lyme Borreliosis testing and recommends a combination diagnostic protocol with Nanotrap® Urine test to confirm active infection and the CDC recommended TTT to detect the presence of antibodies.
You can order here and learn more at galaxydx.com.
About Galaxy Diagnostics
Galaxy Diagnostics offers the only testing solutions powered by revolutionary sample enrichment technologies for elusive flea and tick borne pathogens. The company's mission is to "Go Beyond" the limits of conventional detection by driving scientific innovation, creating new clinical knowledge through research and publication and providing medical education and excellent customer support to healthcare providers, veterinarians, patients, and research customers in this important area of emerging infectious disease.
About Ceres Nanosciences
Ceres Nanosciences is a privately held company, located in Northern Virginia, focused on incorporating its novel Nanotrap® particle technology into a range of diagnostic products and workflows. The Nanotrap® particle technology can improve diagnostic testing by capturing, concentrating, and preserving low abundance analytes from biological samples. The Nanotrap® particle technology was developed with support from the National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (DARPA), the Bill and Melinda Gates Foundation, Schmidt Futures, the Defense Threat Reduction Agency (DTRA), and the Commonwealth of Virginia.
Press release distributed by PRLog
SOURCE Galaxy Diagnostics, Inc.
Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis
Ruben Magni 1 2 , Benjamin H Espina 3 , Ketul Shah 4 , Benjamin Lepene 5 , Christine Mayuga 6 , Temple A Douglas 7 , Virginia Espina 8 , Sally Rucker 9 , Ross Dunlap 10 , Emanuel F Iii Petricoin 11 , Mary Frekko Kilavos 12 , Donald M Poretz 13 , Gilbert R Irwin 14 , Samuel M Shor 15 , Lance A Liotta 16 , Alessandra Luchini 17
Objectives: Prompt antibiotic treatment of early stage Lyme borreliosis (LB) prevents progression to severe multisystem disease. There is a clinical need to improve the diagnostic specificity of early stage Lyme assays in the period prior to the mounting of a robust serology response. Using a novel analyte harvesting nanotechnology, Nanotrap particles, we evaluated urinary Borrelia Outer surface protein A (OspA) C-terminus peptide in early stage LB before and after treatment, and in patients suspected of late stage disseminated LB.
Method: We employed Nanotrap particles to concentrate urinary OspA and used a highly specific anti-OspA monoclonal antibody (mAb) as a detector of the C-terminus peptides. We mapped the mAb epitope to a narrow specific OspA C-terminal domain OspA236-239 conserved across infectious Borrelia species but with no homology to human proteins and no cross-reactivity with relevant viral and non-Borrelia bacterial proteins. 268 urine samples from patients being evaluated for all categories of LB were collected in a LB endemic area. The urinary OspA assay, blinded to outcome, utilized Nanotrap particle pre-processing, western blotting to evaluate the OspA molecular size, and OspA peptide competition for confirmation.
Results: OspA test characteristics: sensitivity 1.7 pg/mL (lowest limit of detection), % coefficient of variation (CV) = 8 %, dynamic range 1.7-30 pg/mL. Pre-treatment, 24/24 newly diagnosed patients with an erythema migrans (EM) rash were positive for urinary OspA while false positives for asymptomatic patients were 0/117 (Chi squared p < 10(-6)). For 10 patients who exhibited persistence of the EM rash during the course of antibiotic therapy, 10/10 were positive for urinary OspA. Urinary OspA of 8/8 patients switched from detectable to undetectable following symptom resolution post-treatment. Specificity of the urinary OspA test for the clinical symptoms was 40/40. Specificity of the urinary OspA antigen test for later serology outcome was 87.5 % (21 urinary OspA positive/24 serology positive, Chi squared p = 4.072e(-15)). 41 of 100 patients under surveillance for persistent LB in an endemic area were positive for urinary OspA protein.
Conclusions: OspA urinary shedding was strongly linked to concurrent active symptoms (e.g. EM rash and arthritis), while resolution of these symptoms after therapy correlated with urinary conversion to OspA negative.
Urinary OspA in patients suspected of having “chronic” LB
...In this study, we evaluated the level of urinary OspA protein in 100 previously or currently treated patients with joint, neurologic, and other objective symptoms (Additional file 1: Table S6). This group of patients were being evaluated for the potential of recurrent or persistent infection with Borrelia. Our analysis was blinded to outcome. 41 of 100 (41 %) patients were positive for urinary OspA protein. This percentage of positive urinary OspA, assuming that it reflects a specific infection by Bb that is shedding OspA C-terminal fragments, is in keeping with prior studies...
...Most, if not all, of these patients have a negative Lyme serology by the 2 tier criteria.
The mAb epitope used herein (red rectangle) is conserved in common pathogenic species of Borrelia.
BAA22342.1 in Borrelia garinii Taxonomy ID 29519, ADD14639.1 in Borrelia burgdorferi taxonomy ID 139,
WP_012665647.1 in Borrelia valaisiana taxonomy ID 62088, WP_012665647.1 in Borrelia sp. SV1 taxonomy ID 498741
YP_003110622.1 in Borrelia burgdorferi 297 taxonomy ID 521009, NP_045688.1 in Borrelia burgdorferi B31 taxonomy ID
224326, WP_014023199.1 in Borrelia bissettii taxonomy ID 64897, ADG02035.1 in Borrelia afzelii taxonomy ID 29518,
AAN65460.1 in Borrelia spielmanii taxonomy ID 88916.
Galaxy Diagnostics offers this test for $295 at the time of writing.