Specific Level of Allergen
IgE Class kU/L Specific IGE Antibody
--------- ------------ ---------------------
0 <0.10 Absent/Undetectable
0/1 0.10 - 0.34 Very Low Level
1 0.35 - 0.69 Low Level
2 0.70 - 3.49 Moderate Level
3 3.50 - 17.4 High Level
4 17.5 - 49.9 Very High Level
5 50 – 100 Very High Level
6 >100 Very High Level
The clinical relevance of allergen results of 0.10 - 0.34 kU/L are undetermined and intended for specialist use. Allergens denoted with a ** include results using one or more analyte specific reagents. In those cases, the test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.