A revolutionary test method to confirm active Borrelia infection.
This urine-based test provides more sensitive direct detection for Borrelia burgdorferi infection at all stages of Lyme disease than standard methods.
- Identifies positive cases missed by conventional Two-Tiered Testing (TTT)
- Reduces concern for false positive results by direct detection of OspA antigen
- Confirms active infection with easy to collect urine samples
Some patients never develop Lyme disease antibodies
How it works
The Lyme Nanotrap® Urine Antigen Test provides more reliable confirmation of active Borrelia burgdorferi infection. Capture and concentration of Outer surface protein A in urine is confirmed by Western blot. Clinical utility data documented 100% sensitivity/98% specificity in 24/24 patients with EM rash and showed 41% positive rate in post-treatment patients monitored for persistent infection (Magni et al 2015 J Translational Medicine). Our proprietary reimbursement codes now reduce the out-of-pocket expense for patients.
Research
Prior research shows that a small amount of Outer surface protein A (OspA) antigen is detectable in the urine of Lyme disease patients. Nanotrap® particle sample enrichment greatly increases the likelihood of direct detection of these low abundance proteins. Based on preliminary studies, Nanotrap® sample enrichment can increase the concentration of low-abundance targets by 10,000-fold.
Data
Published data shows the Nanotrap® Antigen Test is very effective for confirmation of early stage Lyme borreliosis in patients with EM rashes (24/24). Galaxy validation data (unpublished) shows it is able to detect active infection in patients with negative TTT results.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.
Experts recommend combining direct detection test methods with indirect antibody testing to maximize the diagnostic data for low abundance infections, like Lyme borreliosis. We recommend ordering both the Nanotrap® Antigen Test and Two-Tier Testing (ELISA with reflex to Western blot) for confirmation of a Lyme disease diagnosis.
How does the Lyme Borrelia Nanotrap® Antigen Test compare to serology tests?
The Nanotrap® Antigen Test is a direct detection test method that captures and concentrates OspA antigen to more accurately confirm Lyme disease diagnosis. Serology tests are indirect, detecting the presence of antibodies to Borrelia burgdorferi, only confirming prior exposure.
The Center for Disease Control (CDC) recommends using two-tier testing (TTT). This platform combines two test methods (ELISA and Western blot) aimed at detecting antibodies specific to Borrelia species. However, antibody (IgM and IgG) testing for Lyme borreliosis faces multiple challenges including:
- Limited sensitivity in the absence of a robust immune response.
- Delayed antibody response up to 4-6 weeks after transmission.
- False positive diagnosis based on antibodies detected after an infection is actually cleared.
- False positive test result due to antibody cross-reactivity with other microbes who share similar proteins.
- Complicated and controversial interpretation of Western blot results with an important trade off between false positive and false negative risks depending on interpretation criteria.
FAQS
What Borrelia species can be detected?
The Nanotrap® test is targeting the OspA protein, which can be found on the surface of Borrelia species belonging to both major groups (sensu stricto and sensu lato). The test will only determine if OspA is present, not which Borrelia species was detected.
How do I order the Nanotrap®test?
A licensed healthcare provider can order a urine kit using our online order form. The kit can be shipped to the provider’s office, or directly to the patient. It will include a urine cup, the necessary paperwork, specimen collection instructions, and packing/shipping materials.
How much urine is needed?
The Nanotrap® test requires at least 40 mL of urine. The cup provided in Galaxy’s specimen collection kit has a sticker marking the required amount. We recommend collecting as much as possible in case some sample is spilled during transit.
Can the urine be stored?
We recommend shipping samples the same day that the urine is collected. If necessary, the urine can be stored in the refrigerator for 24-48 hours. Please do not ship on Fridays or prior to holidays.
How should the urine be shipped?
We recommend shipping the urine the same day it is collected. It should be shipped overnight with a completely frozen ice pack. Please do not ship on Fridays.
Is the Nanotrap® Urine Test covered by private insurance/Medicare/Medicaid?
Due to the novelty of the Nanotrap® sample enrichment technology, the test has not been assigned a specific CPT code. This means that it is self-pay only at this time. We are working with insurance reimbursement professionals to create a CPT/PLA code that will allow for insurance filing. More information about billing and insurance can be found here.