This assay is performed using the QuantiGlo® Chemiluminescent EIA kit. Values obtained with different assay methods or kits cannot be used interchangeably.
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.