This test identifies and quantifies the CD57+/CD3-NK cells. The significance of low CD57+NK values in diagnosing and monitoring chronic Lyme disease is not well established and should be used in conjunction with other diagnostic tests specified in the Centers for Disease Control Lyme Disease case definition.
Compliance Statement A
: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. 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. This test should not be regarded as investigational or for research use.