Finally the Ceres Lyme test has come to market. This new test will benefit everyone. Not only does it reliably detect early Lyme disease, but it is able to detect chronic cases of Lyme disease as well.The target of the Nanotrap® LA Test measurement, Outer surface protein A (OspA), was identified as a valid biomarker for detecting Lyme disease based on the following findings from highly regarded scientific publications: OspA is a protein found only on the surface of Borrelia burgdorferi (Bb), and OspA antibodies are detectable in patients in early and late stage disease (Infect. Immun. 1995, 63:2228-2235) and in antibiotic resistant Lyme (Arthritis Rheum. 1999 42:1809-1812); Bb expresses high levels of OspA in the mammalian host in an inflammatory environment (Infect. Immun. 2003, 71,7; 4003-4010); OspA has inflammatory properties (stimulation of neutrophils, The Journal of Immunology, 1997, 4838); OspA and surface lipoproteins provide protective shielding against mammalian host innate immunity (Mol Microbiol. 2008; 69(1): 15–29); OspA has been found in Lyme patient urine, cerebrospinal fluid and synovial fluid.
George Mason University set up its own trial, in partnership with Ceres Nanosciences, Inc, and multiple infectious disease clinics and internal medicine practices to further develop this finding into a reliable diagnostic test.
Over 300 patients participated in the clinical trial. Urine samples were collected from every patient and both the current standard of care serological testing and the Nanotrap® LA Test were run for each patient sample and analyzed in conjunction with the physician’s report of symptoms and history with Lyme disease. This study has been published in a peer reviewed scientific journal, 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.
The study demonstrates the following key findings: Bb antigen OspA is present in the urine of patients at early stage disease (sensitivity < 1.7 pg/mL); Patients who were asymptomatic following treatment were noted to revert from positive to negative; For patients under treatment for Lyme disease, the presence of antigen in the urine correlates strongly with the presence of symptoms; Bb antigen is shed in the urine only in presence of active infection producing symptoms.
This new test is available through labs for about $400 as of this writing.