Thermo Scientific™ ImmunoCAP™ Mold and Yeast Allergens

Catalog No.	Quantity	Code	Common Name	Regulatory Status
14-411-901P	16 Tests	m3	Aspergillus fumigatus	FDA Cleared
14-410-601P	16 Tests	m6	Alternaria alternata	FDA Cleared
14-410-501P	16 Tests	m2	Cladosporium herbarum	FDA Cleared
14-412-001P	16 Tests	m5	Candida albicans	FDA Cleared
14-414-501P	16 Tests	m4	Mucor racemosus	FDA Cleared
14-416-001P	16 Tests	m1	Penicillium chrysogenum (P. notatum)	FDA Cleared
14-425-801P	16 Tests	m7	Botrytis cinerea	FDA Cleared
14-426-001P	16 Tests	m9	Fusarium proliferatum (F. moniliforme)	FDA Cleared
14-425-901P	16 Tests	m8	Setomelanomma rostrata (Helminthosporium halodes)	FDA Cleared
14-426-101P	16 Tests	m10	Stemphylium herbarum (S. botryosum)	FDA Cleared
14-426-201P	16 Tests	m11	Rhizopus nigricans	FDA Cleared
14-426-401P	16 Tests	m13	Phoma betae	FDA Cleared
14-426-301P	16 Tests	m12	Aureobasidium pullulans	FDA Cleared
14-426-601P	16 Tests	m15	Trichoderma viride	FDA Cleared
14-426-501P	16 Tests	m14	Epicoccum purpurascens	FDA Cleared
14-426-701P	16 Tests	m16	Curvularia lunata	FDA Cleared
14-448-301P	16 Tests	m205	Trichophyton rubrum	FDA Cleared
14-483-001P	10 Tests	m202	Acremonium kiliense	FDA Cleared
14-483-101P	10 Tests	m207	Aspergillus niger	FDA Cleared
14-488-901P	10 Tests	m80	Staphylococcal enterotoxin A	FDA Cleared
14-489-001P	10 Tests	m81	Staphylococcal enterotoxin B	FDA Cleared
14-494-010P	10 Tests	Rm46	Bipolaris spicifera	ASR
14-502-910P	10 Tests	Rm201	Tilletia tritici	ASR
14-502-810P	10 Tests	Rm204	Ulocladium chartarum	ASR
14-520-210P	10 Tests	Rm208	Chaetomium globosum	ASR
14-520-310P	10 Tests	Rm209	Penicillium glabrum	ASR
14-522-410P	10 Tests	Rm211	Trichophyton mentagrophytes var. interdigitale	ASR
14-530-110P	10 Tests	Rm226	Staphylococcal enterotoxin TSST	ASR
14-434-901P	10 Tests	m70	Pityrosporum orbiculare (syn. Malassezia)	FDA Cleared

Catalog No. 14-411-901P Supplier Thermo Scientific™ Supplier No. 14411901

Description

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

Quantify specific IgE antibodies with ImmunoCAP™ Mold and Yeast Allergens, essential tools to aid in the diagnosis of allergic conditions. IgE antibodies appear in human serum and plasma as a result of sensitization to a specific allergen. Measurement of circulating IgE antibodies provides an objective assessment of sensitization to an allergen. In general, low IgE antibody levels indicate a low probability of allergic disease, whereas high antibody levels to an allergen show a higher correlation with an allergic disease.

ImmunoCAP Specific IgE offers the laboratory:

• Truly quantitative measuring range from 0.1 to 100 kUA/L
• Intra-assay CV (%) comparable to routine clinical chemistry immunoassays
• Excellent consistency over time, and between countries, systems, labs and persons

Expected test values
ImmunoCAP Specific IgE detects IgE antibodies in the range 0.1 to 100 kUA /l, where A represents allergen-specific antibodies. The result is reported quantitatively. In clinical practice, 0.35 kUA /l has commonly been used as a cut-off. A large number of studies have been performed to evaluate the clinical performance of ImmunoCAP Specific IgE tests in allergy diagnosis. Clinical performance is expressed as sensitivity, ranging from 84 to 95%, and specificity, ranging from 85 to 94%. Sensitivity and specificity were reported from multi-center studies including several hundred patients tested for a range of different allergens.

• Specimen collection and preparation
• Use serum and plasma (EDTA or heparin) samples from venous or capillary blood
• 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

Note: Blood samples for testing ImmunoCAP drugs and venom should be collected during or close to the event, preferably not later than 6 months after exposure. If the test result is negative and an IgE-mediated reaction is still strongly suspected, it is advisable to draw a new sample and repeat the test at 5 to 6 weeks.

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:

• The allergy march – a progression of skin symptoms to respiratory symptoms
• 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
• Common Name: Aspergillus fumigatus
• Quantity: 16 Tests
• Code: m3