Allergen results of 0.10-0.34 kU/L are intended for specialist use as the clinical relevance is undetermined. Even though increasing ranges are reflective of increasing concentrations of allergen-specific IgE, these concentrations may not correlate with the degree of clinical response or skin testing results when challenged with a specific allergen. The correlation of allergy laboratory results with clinical history and in vivo
reactivity to specific allergens is essential. A negative test may not rule out clinical allergy or even anaphylaxis.
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.