Kenota 1 CWS Method Comparison Validation Study

The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. The main questions it aims to answer are:Are the Kenota 1 Devices easy to use by untrained operators at a clinic environment?Do tIgE results provided by the Kenota 1 Devices match the results provided by the FDA-cleared Phadia ImmunoCAP System?Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.

Inclusion Criteria:Ages <80 yearsFrom all Ethnic/Racial backgroundsExclusion Criteria:Individuals older than 80 years of ageIndividuals with skin damage, burns or scars at the site of venipuncture on both arms