Bacterial infectious disease IVDs

Intended purpose

The intended use of Borrelia ViraStripe IgM and IgG test kits are for the confirmation of Lyme disease. It is generally used as a secondary test to support the findings of a Lyme immunofluorescence assay or enzyme-immunoassay. It is used for the qualitative detection of IgM and IgG antibodies against specific Borrelia antigens in human serum. The testing is performed in the diagnostic laboratory environment. Limitations include possible cross-reaction with other spirochetes.