B. burgdorferi IgM Test System

Intended Use

The ZEUS ELISA Borrelia burgdorferi IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease.  

Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following approaches: 

1. Standard two-tier test methodology (STTT) using IgM Western blot testing following current guidelines; or
2. Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System. 

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data. 

Registration / Clearance

FDA Cleared

CE Marked

Health Canada Licensed