West Nile Detect™ IgM Capture ELISA

The West Nile Detect™ IgM Capture ELISA is designed for the qualitative detection of IgM antibodies to West Nile recombinant antigens in human serum. This test is intended for use for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test, or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors. Caution: IgM assay cross-reactivity has been noted with some West Nile IgM assays testing specimens containing antibody to enteroviruses. Reactive results reported from children must contain a caution statement regarding possible cross-reactivity with enteroviruses.