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This test was developed, and its performance characteristics determined, by LabCorp. This test has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. This test should not be regarded as investigational or for research.
Quantitative allergen-specific IgE test results should be interpreted in the context of all available clinical and laboratory findings. High levels of total IgE (>3000 IU/mL may be seen due to parasitic infestation or other conditions) may result in nonspecific binding. Testing in these patients should be reëvaluated once the medical condition has been eliminated.
Thermo Fisher ImmunoCAP®