A positive result does not necessarily rule out infection with a different Flavivirus
spp. The best evidence of current infection is a significant change on two appropriately timed specimens with both tests performed in the same laboratory at the same time.
Compliance Statement D
: 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.