Borrelia VlsE1/pepC10 IgG/IgM Test System

Intended Use

The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease.

Positive and equivocal test results with the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/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 IgG or IgM Western blot testing; or
2. Modified two-tier test methodology (MTTT) using one or more of the following three ELISA-based assays:

• ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
• ZEUS ELISA Borrelia burgdorferi IgM Test System
• ZEUS ELISA Borrelia burgdorferi IgG 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.  

Other Description

• Achieves superior clinical sensitivity for detecting early, acute Lyme disease
• Achieves superior clinical specificity, reducing false positive results
• Yields excellent assay reproducibility using highly purified synthetic, recombinant antigens

Registration / Clearance

FDA Cleared

CE Marked

Health Canada Licensed