This test is intended to be used as a semi-quantitative means of detecting St. Louis virus-specific IgM in CSF samples in which there is a clinical suspicion of St. Louis virus infection. A positive result for IgM may suggest current or recent 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 West Nile virus, show extensive cross-reactivity with St. Louis virus, serologic testing specific for these species should also be performed.
See Compliance Statement B
Statement B: 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.