This test is intended to be used as a semi-quantitative means of detecting West Nile virus-specific IgG and IgM in CSF specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered.
The detection of antibodies to West Nile virus in cerebrospinal fluid may indicate central nervous system infection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across the blood-brain barrier.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.