Thermo Scientific™ ImmunoCAP™ Mold and Yeast Allergen Mixes

Measure specifc IgE antibodies using ImmunoCAP™ allergens, an essential tool to aid in the diagnosis of allergic conditions.

Catalog Number	Mfr. No.	Common Name	Code	Quantity	Regulatory Status
14-420-401P	Thermo Scientific™ 14420401	m1, m2, m3, m6	mx1	16 Tests	FDA Cleared
14-432-001P	Thermo Scientific™ 14432001	m1, m2, m3, m5, m6, m8	mx2	16 Tests	FDA Cleared

Description

Identify specific IgE antibodies to broad categories of allergens with ImmunoCAP™ Mold and Yeast Allergen Mixes, essential tools to aid in the diagnosis of allergic conditions. IgE antibodies appear in human serum and plasma as a result of sensitization to specific allergens. Qualitative measurement of circulating IgE antibodies to allergen mixes provide an assessment of sensitization to group of related allergens. Reflex testing to the individual whole allergens that make up an allergen mix is generally recommended to identify the allergen specific IgE.

ImmunoCAP Specific IgE Mixes offers the laboratory:

• Detection limit ≥ 0.35 kUA/L
• Qualitative results
• Ability to detect specific IgE to multiple allergens in one test
• Excellent consistency over time, and between countries, systems, labs and persons

Expected test values
Test results for ImmunoCAP Allergen Mixes are derived from multiple allergens and are reported as qualitative values (positive or negative). A cut-off value of 0.35 kUA/L is recommended for ImmunoCAP multiple allergens. Values between limit of quantification and 0.35 kUA/L may represent very low levels of IgE antibodies. Values ≥0.35 kUA/L indicate specific IgE antibodies to one or more of the allergens coupled to ImmunoCAP multiple allergen. Reinvestigation with appropriate ImmunoCAP single allergen is recommended when there is a need to further identify and obtain a quantitative result for the specific allergen(s). A value below 0.35 kUA/L indicates undetectable or very low levels of allergen specific IgE antibodies towards all of the allergens bound to ImmunoCAP multiple allergen but deviations from results obtained with single ImmunoCAP allergens may occur. The interpretation of results obtained with ImmunoCAP multiple allergen cannot be compared with the results with ImmunoCAP single allergen. The degree of positivity of ImmunoCAP multiple allergen cannot be considered the cumulative degree of positivity of the respective ImmunoCAP single allergen.

Specimen collection and preparation

• Serum and plasma (EDTA or heparin) samples from venous or capillary blood can be used
• Collect blood samples using standard procedures
• Keep specimens at room temperature (RT) for shipping purposes only
• Store at 2-8°C up to one week, otherwise store at -20°C
• Avoid repeated freezing and thawing

The presence of specific IgE antibodies is useful to identify the allergens that elicit symptoms and signs of allergy in patients with respiratory allergic diseases including asthma, food allergy, and anaphylactic sensitivity.

Knowing IgE antibody levels provides guidance to clinicians to:

• Identify offending allergens
• Tailor advice to individual patients
• Indicate development of tolerance (food allergy, specific immunotherapy)
• Inform optimized individual medical treatment plans
• Refer to specialists appropriately
• Evaluate whether or not specific immunotherapy is an option

Specific IgE testing also aids in the identification of patients at risk of:

• Severe symptoms including asthma exacerbations—a progression of mild symptoms to severe symptoms
• Progression of recurrent symptoms to persistent symptoms

As in all diagnostic testing, a definitive clinical diagnosis should be made by the clinician after evaluation of all clinical and laboratory findings.

Specifications

• Regulatory Status: FDA Cleared
• Code Type: Mold/Yeast
• Quantity: 16 Tests