Nanotrap® Lyme Antigen Test (Nanotrap® LA Test)
A GAME CHANGING TOOL FOR LYME DISEASE DIAGNOSIS
The Nanotrap® Lyme Antigen Test is powered by the novel Nanotrap® nanoparticle technology. Orinigally invented to detect cancer at the earliest stages, these nanoparticles have been adapted to many areas of infectious disease detection, including malaria, tuberculosis, Ebola, and Zika.
This technology is patented and widely published in scientific journals and has been developed for over a decade with funding from the Department of Defense, the National Institutes of Health, and the Bill and Melinda Gates Foundation.
The Nanotrap® nanoparticles capture and enrich the Lyme antigen present in a patient's urine sample and make it available for routine measurement with great accuracy.
The results of the clinical study to develop this test were published in the Journal of Translational Medicine:
“Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis”
Lyme Antigen = Outer Surface Protein A (OspA), a protein shed by the spirochetal bacteria, Borrelia, and may be present at all stages of Lyme infection, especially in the early stages of transmission.
High Sensitivity and Specificity
Direct test for Lyme infection
Urine test (non-invasive)
Collect sample at home or office
High accuracy of detection
Patient urine samples are collected and shipped to a CAP/CLIA laboratory in Virginia where they are processed under clinical grade quality controls. All test results are reviewed by a certified clinical pathologist before being reported out to physicians.
Watch video demonstration of test processing in clinical lab
I want to offer this test to my patients
Depending on how you plan to order this test for your patients, there are a few options to consider for getting kits to your patients and delivering collected specimens back to our lab.
1) The patient cannot come to your office for sample collection
We can send a single collection kit directly to your patient and they will be able to collect sample and ship back to our lab. For this, we ask that the patients order a kit directly through our website order form and reference your clinic in the order.
2) The patient can come to your office but prefers to collect a sample at home
We can send your office a batch of 6 individual collection kits (they come in sixes). You can provide kits and order forms to patients at your office and they can self-collect and ship back to our labs or you can ship to our lab directly from your office.
3) Your office prefers to collect samples and ship directly to Ceres
You can ship individual kits as samples are collected. If you plan to perform more than 2 tests per week, we recommend that you batch the samples and orders for shipment. Please contact us to discuss options. Depending on anticipated volumes and other factors, there are several ways to facilitate this process.
For options 1, 2, and 3, your office or the patient will be required to prepare the shipment and package the samples with the provided ice pack. All completed/signed forms must be included with the shipment. For option 4, we can discuss the best way to prepare and ship batched samples, based on anticipated volumes and what works best for your office.
Disclaimer: The performance characteristics of this test have been developed and validated through George Mason University and Ceres Nanosciences, and are published (Magni et al. J Transl Med (2015) 13:346), and have not been cleared or approved by the FDA or the CDC. The FDA has determined that at this time such clearance or approval is not currently necessary. This laboratory developed test should be regarded as investigational or research use.
It is validated by George Mason University and Ceres Nanosciences pursuant to and in compliance with the Clinical Laboratory Improvements Amendments and accompanying regulations (“CLIA”) and pursuant to compliance under the College of American Pathologists (“CAP”) regulations. The results must be considered within the clinical context and history of the patient. Decisions on patient care and treatment must be based on the independent discretion of the treating physician. Ceres will not transmit test results directly to a patient. All results will be reported to the treating physician.