Intended Use
Enzyme immunoassay (microtiter strips) for the quantitative determination of IgG antibodies against 88 Food Allergens in human serum and plasma.
Contents of Kit
Microtiter Plate:Break apart strips. Coated with 88 different nutritional allergens and 8 x reference allergen. Ready to use. Quantity: 1 x 12 x 8
Enzyme Conjugate IgG:Ready to use. Contains goat-a-human-IgG-AP in proteinacious buffer solution. Quantity: 1 x 15 mL
Calibrator A - F:0.35, 0.70, 3.5, 17.5, 50, 100 U/mL Ready to use. Contains: IgG antibodies against reference allergen, human plasma diluted with PBS/BSA, 0.05% sodium azide. Quantity: 1 x 6 x 0.5 mL
Control 1+2:Ready to use. Contains: IgG antibodies. Addition of 0.05% sodium azide. Quantity: 1 x 2 x 0.5 mL
Diluent Buffer:Ready to use. Contains: Tris/BSA buffer, 0.05% sodium azide. Quantity: 1 x 40 mL
Wash Buffer, Concentrate (10x), Contains: PBS + Tween 20. Quantity: 1 x 60 mL
PNPP Substrate Solution: Paranitrophenylphosphate (PNPP), Ready-to-use. Quantity: 1 x 15 mL
PNPP Stop Solution: 1 M sodium hydroxide. Ready-to-use. Quantity: 1 x 15 mL
Adhesive Foil, Quantity: 2 x
Storage
The kit is shipped at ambient temperature and should be stored at 2-8°C. Keep away from heat or direct sun light. The storage and stability of specimen and prepared reagents is stated in the corresponding chapters. The strips and solutions have to be stored at 2-8°C. The expiry date is mentioned on the labels.
Performance Characteristics
General Description
Lucretius once said that one man's food may be another man's poison. Individuals with allergies and other types of food sensitivities react adversely to certain foods and food ingredients that others can consume with no problems. Many different types of reactions are involved in these individual adverse reactions. Adverse food reactions may include IgE and non-IgE-mediated primary immunological sensitivities, non immunological intolerances (such as an enzyme deficiency or reactions to certain chemicals), as well as secondary sensitivities.
Adverse immune reactions to foods which are not IgE mediated are often called food "intolerances". The absence of IgE does not make them any less real; instead, other immune mechanisms, such as IgG or IgG4 antibodies are involved. IgG or IgG4-mediated adverse reactions to food are characterized by less severe reactions, are much more common (affecting approx. 45 % of the population) and have delayed onset (2 to 72 hours) after ingestion of an offending substance. Avoiding ingestion of such food (exclusion or rotation diet) is the best treatment to decrease symptoms.
There are several evidences for the involvement of IgG or IgG4 in food "intolerances" e.g.:
• Allergic reactions may occur independently of antigen-specific IgE
• Subsequent decrease of IgG when the offending food is removed from the diet
• Specific serum IgG has been reported in cases of celiac disease, dermatitis, or atopic eczema, as well as in diseases with increased intestinal permeability, and inflammatory bowel disease (IBD)
This evidence leads to the recommendation that IgG or IgG4-specific testing should be considered in cases where the patient shows unclear and chronic disorders, and in cases where classical diagnostics show no evidence.