Intended for diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

Gold serum separator (SST) tube

• For more than one allergen, use this formula to calculate the amount of serum required:

50 µL X (# of allergens) + 250 µL = total amount serum needed

• Immediately following collection, mix sample by gently inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection

Gold serum separator (SST) tube

Red serum vial/tube - 5 mL

Red/grey serum separator (SST) vial/tube, 10 mL

1. Allow sample to clot
2. Spin
3. Transfer serum to a False bottom plasma/serum transport vial/tube (AHL), labelled as serum, within two (2) hours of sample collection

False bottom plasma/serum transport vial/tube (AHL)

Red/grey serum separator (SST) vial/tube, 10 mL

Ambient (preferred) - 3 days

Refrigerated - 7 days

Frozen (OK, one time)

• Improper labels (unlabeled or mislabeled)
• Hemolysis (some procedures)
• Improper anticoagulant or ratio
• Delay in transport
• Improper storage temperature affecting results
• Improper container
• Leaking container resulting in compromised specimen
• Quantity not sufficient (QNS)

Fluorescence Enzyme Immunoassay (FEIA)

< 0.35 kU/L

Allergy class severity values

ImmunoCAP IGE Class Reference Values:

Traditionally, allergen tests have been reported with an associated class value of zero to 6, with Class 0 indicating an undetectable allergen level, and Class 6 indicating a strong positive allergen level.

The following chart correlates ImmunoCAP IgE allergen results in kU/L to the associated class, with a suggested interpretation. This chart is applicable to all allergen-specific tests at Allina Health Laboratory, which are performed exclusively on ImmunoCAP assays. Note that the Class Reference Values provided are specific for ImmunoCAP assays and may not be used to interpret allergy tests performed by other (non-ImmunoCAP) methods.

Medical necessity