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.
Statement A: Compliance Statement A
: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay.
Analyte Specific Reagent. 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, the FDA has determined that such clearance or approval is not necessary.