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EU Lyme + VlsE IgG

Technology : Western Blot

Brand : MarDx®

Analyte : Infectious Diseases ~ Lyme

Intended Use

The Trinity Biotech EU Lyme + VlsE IgG Enzyme Immunoassay (EIA) Test System is a qualitative test intended for use in the presumptive detection of human IgG antibodies to Borrelia afzelii, Borrelia garinii, and Borrelia burgdorferi(B-31) including the VlsE Protein in human serum. This EIA system should be used to test serum from patients with a history and symptoms of infection with Borrelia. All positive and equivocal specimens should be re-tested with a highly specific, second-tier test such as Western blot. Positive second-tier results are supportive evidence of infection with Borrelia. The diagnosis of Lyme disease should be made based on history and symptoms (such as erythema migrans), and other laboratory data, in addition to the presence of antibodies to Borrelia afzelii, Borrelia garinii and B. burgdorferi(B-31) including the VlsE protein. Negative results (either first or second-tier) should not be used to exclude Lyme disease.

Principle

The Trinity Biotech EU Lyme Disease IgG Test System is an indirect enzyme immunoassay (EIA) technique utilizing the purified native antigens of Borrelia afzelii (PKO), Borrelia garinii (G2) and B. burgdorferi (B 31) including the specific VlsE protein which are bound to polystyrene microwells. The antibody from the patient sample, which is added to the microwells in the first step of this procedure, binds with the antigen. Following a rinsing period which removes unbound antibody, a peroxidase labeled anti-human IgG is added to each microwell. The conjugate will attach during the second incubation step only if bound human IgG antibody is present from the first step reaction. Following a second rinsing period which removes unbound peroxidase conjugate, a color indicator solution is added to the microwells which will react only in the presence of bound peroxidase. An acid solution is added after a specified period of time in order to stop the enzymatic conversion of the indicator solution for spectrophotometric analysis.

Product Code : 44-8696G

Format : 96 tests

Test/Kit : 96 tests

CE : Cleared

Package Inserts
EU Lyme + VIsE IgG (Multi-lingual)
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