The LIAISON® Borrelia burgdorferi assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer (Model 15970) for the qualitative presumptive detection of IgG and IgM antibodies to VlsE (variable major protein-like sequence, expressed) protein antigen of Borrelia burgdorferi in human serum. This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Borrelia burgdorferi assay should not be used to exclude Lyme disease. Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed practitioner.