Cross reactivity with Brucella
antibodies may occur. Therefore, results should be interpreted with caution and correlated with clinical information. The best evidence for current infection is a significant change on two appropriately timed specimens, where both tests are performed in the same laboratory at the same time.
Statement D: Compliance Statement D
: For laboratory tests using a manufactured RUO kit.
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.