Thermo Scientific™ ImmunoCAP™ Mold and Yeast Allergens

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
14-410-601P	Thermo Scientific™ 14410601	Alternaria alternata	m6	16 Tests	FDA Cleared
14-410-501P	Thermo Scientific™ 14410501	Cladosporium herbarum	m2	16 Tests	FDA Cleared
14-411-901P	Thermo Scientific™ 14411901	Aspergillus fumigatus	m3	16 Tests	FDA Cleared
14-412-001P	Thermo Scientific™ 14412001	Candida albicans	m5	16 Tests	FDA Cleared
14-414-501P	Thermo Scientific™ 14414501	Mucor racemosus	m4	16 Tests	FDA Cleared
14-416-001P	Thermo Scientific™ 14416001	Penicillium chrysogenum (P. notatum)	m1	16 Tests	FDA Cleared
14-425-801P	Thermo Scientific™ 14425801	Botrytis cinerea	m7	16 Tests	FDA Cleared
14-426-001P	Thermo Scientific™ 14426001	Fusarium proliferatum (F. moniliforme)	m9	16 Tests	FDA Cleared
14-425-901P	Thermo Scientific™ 14425901	Setomelanomma rostrata (Helminthosporium halodes)	m8	16 Tests	FDA Cleared
14-426-101P	Thermo Scientific™ 14426101	Stemphylium herbarum (S. botryosum)	m10	16 Tests	FDA Cleared
14-426-201P	Thermo Scientific™ 14426201	Rhizopus nigricans	m11	16 Tests	FDA Cleared
14-426-401P	Thermo Scientific™ 14426401	Phoma betae	m13	16 Tests	FDA Cleared
14-426-301P	Thermo Scientific™ 14426301	Aureobasidium pullulans	m12	16 Tests	FDA Cleared
14-426-601P	Thermo Scientific™ 14426601	Trichoderma viride	m15	16 Tests	FDA Cleared
14-426-501P	Thermo Scientific™ 14426501	Epicoccum purpurascens	m14	16 Tests	FDA Cleared
14-426-701P	Thermo Scientific™ 14426701	Curvularia lunata	m16	16 Tests	FDA Cleared
14-448-301P	Thermo Scientific™ 14448301	Trichophyton rubrum	m205	16 Tests	FDA Cleared
14-483-001P	Thermo Scientific™ 14483001	Acremonium kiliense	m202	10 Tests	FDA Cleared
14-483-101P	Thermo Scientific™ 14483101	Aspergillus niger	m207	10 Tests	FDA Cleared
14-488-901P	Thermo Scientific™ 14488901	Staphylococcal enterotoxin A	m80	10 Tests	FDA Cleared
14-489-001P	Thermo Scientific™ 14489001	Staphylococcal enterotoxin B	m81	10 Tests	FDA Cleared
14-494-010P	Thermo Scientific™ 14494010	Bipolaris spicifera	Rm46	10 Tests	ASR
14-502-910P	Thermo Scientific™ 14502910	Tilletia tritici	Rm201	10 Tests	ASR
14-502-810P	Thermo Scientific™ 14502810	Ulocladium chartarum	Rm204	10 Tests	ASR
14-520-210P	Thermo Scientific™ 14520210	Chaetomium globosum	Rm208	10 Tests	ASR
14-520-310P	Thermo Scientific™ 14520310	Penicillium glabrum	Rm209	10 Tests	ASR
14-522-410P	Thermo Scientific™ 14522410	Trichophyton mentagrophytes var. interdigitale	Rm211	10 Tests	ASR
14-530-110P	Thermo Scientific™ 14530110	Staphylococcal enterotoxin TSST	Rm226	10 Tests	ASR
14-434-901P	Thermo Scientific™ 14434901	Pityrosporum orbiculare (syn. Malassezia)	m70	10 Tests	FDA Cleared

Description

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

• Code Type: Mold/Yeast