This test is intended to be used as a semi-quantitative means of detecting California Encephalitis Group virus-specific IgM in CSF samples in which there is a clinical suspicion of California Encephalitis Group 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. La Crosse virus is related within the California Encephalitis Group and generally is reactive with antibody to other viruses within this group.
Compliance 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.