Galaxy - Lyme Borrelia Nanotrap Antigen Test Kit

• 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

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.

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 Galaxy validation data (unpublished) shows it is able to detect active infection in patients with negative TTT results.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.

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.