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SKU Number : 30298-01

For Use on VIDAS® and miniVIDAS® Platforms 60 Tests per Box

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The VIDAS® Lyme IgG and IgM (LYT) assay is intended for use on the instruments of the VIDAS family (VITEK® ImmunoDiagnostic Assay System) as an automated qualitative enzyme-linked fluorescent immunoassay (ELFA) for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection.

Positive or equivocal results should be supplemented by using a secondstep assay method to increase specificity. Positive supplemental results provide serological evidence of infection with B. burgdorferi. The diagnosis of Lyme disease must be made based on history, signs (such as erythema migrans), symptoms, and other laboratory data, in addition to the presence of antibodies to B. burgdorferi. Negative results (either first-or second-step) should not be used to exclude Lyme disease.