Bacterial infectious disease IVDs

Intended purpose

The Diagnostic Automation/ Cortez Diagnostics, Inc B. burgdorferi IgG/IgM IFA test system is designed for the qualitative and semi-quantitative presumptive detection of antibodies (IgG and IgM) to Borrelia burgdorferi in human serum. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. The testing is performed in the diagnostic laboratory environment. Limitations include possible cross-reaction with other spirochetes.