The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IgG II and must have a positive titer (≥ 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (≤ 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy. VIDAS TOXO IgG Avidity assay performance has not been established for prenatal screening, for newborn testing, for use in immunocompromised patients and in cases of endogenous or exogenous reinfection by Toxoplasma gondii. This assay has not been cleared or approved by the FDA for blood/plasma donor screening.