Instruction for use. 1. Intended use 2. Clinical value 3. Materials 4. Reservations 5. Storage and stability 6. List of biotinylated allergens

Transcription

1 Catalogue of biotinylated allergens Produced by Ramintec IPC for use with ELISA kit «Vitrotest Specific-IgE» Instruction for use 1. Intended use 2. Clinical value 3. Materials 4. Reservations 5. Storage and stability 6. List of biotinylated allergens For in vitro diagnostic use ТК 071

2 Biotinylated allergens for use with the test-kit «Vitrotest Specific-IgE» 1. Intended use Biotinylated allergens are intended for the quantitative determination of the content of specific IgE class antibodies in serum or plasma. Allergens are used alongside with ELISA test-kit «Vitrotest Specific-IgE», therefore, the conditions of the analysis see the manual of the test-kit. 2. Clinical value According to WHO, at present in 30-40% of the world there are one or more allergic diseases, about 250 thousand people die of asthma only every year. Allergy is increased sensitivity to a substance (allergen) that occurs when the body's repeated contact with this allergen. In Ukraine there is no actual statistics of allergic diseases. However, when focus on the data of domestic and foreign sources, distribution of allergies in our country is 20-30% (not less than 10 million citizens). The rapid growth in the number of allergic diseases associated with increased allergenic load per person. Hypersensibilization can be caused by pollen, foods (cow's milk, fish, eggs, cereals, vegetables and fruit orange or red, seafood), house dust, fur and particles epithelium of animals, molds and yeasts, drugs, synthetic materials, etc. WHO experts emphasize that the extent of allergy will increase due to air pollution and global warming. These changes in the environment affect the content of pollen in the air, size of stinging insects and molds population that cause allergies. The most common manifestations of allergy, according to WHO, is allergic rhinitis (10-30% of the population), allergic conjunctivitis, rhinosinusitis, asthma (20%), food allergy ( million people), anaphylaxis, urticaria and angioedema, allergic to poison stinging insects (often fatal) medical and occupational allergy. Children allergic disease ranks first among chronic diseases, with most of them is food allergy (5 to 15% of children). For an effective desensitization of body it should be identify allergens that caused some allergic condition. Today with this purpose are used methods of diagnosis of allergy in vitro; one of them is enzyme immunoassay (ELISA) for the determination of total IgE which allows determining the content of total IgE and allergen-specific IgE in serum or plasma. This method has several advantages: no contraindications to survey and age restrictions, does not cause additional sensitization and anaphylactic reactions. It should be noted that the choice of biotinylated allergens allows in individual laboratories to create unique allergic panel depending on regional characteristics (eg, on what plants are in the region and time of flowering) and use the most relevant food allergens that result will best meet the demands of doctors and patients. 3. Materials Biotinylated allergens each vial containing 1,8 ml buffer solution of biotinylated allergens with stabilizers and preservatives (yellow). Ready to use. The contents of one vial is sufficient for 16 determinations. The labels of bottles specified code numbers and names of allergens. Catalogue numbers are in line with international practice. Biotinylated allergens are listed in point 6. Please note that the list of allergens may be extended upon request. 4. Reservations: do not use expired biotinylated allergens; protect biotinylated allergens from straight sun rays. Biotinylated allergens produced by Ramintek IPC are intended for use in the test-kit «Vitrotest Specific-IgE». Responsibility for usafe of these allergens in other commercial test kits fully relies on consumer. 5. Storage and stability Biotinylated allergens are stable up to the expiry date on the label, when stored at 2-8 С. Transport biotinylated allergens at 2-8 ºС. Disposable transportation at temperature not higher than 20ºС during two days is allowed. For questions and suggestions regarding the kit, contact the manufacturer: Ramintek Innovation-Production Company Ukraine, Kiev, 7 October 40th Anniversary Av., of. 227 (registered address) Vishgorod, Kiev region, 19 Sholudenko Str. (factual address) Tel

3 6. List of biotinylated allergens Domestic allergens D1 House dust mites Dermatophagoides pteronyssinus D2 House dust mites Dermatophagoides farinae Н1 Code E1 E2 E3 E5 E6 E70 E83 E85 E86 E89 Code F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12 F13 F14 House Dust Mixture Name of allergen Cat (еpithelial) Dog (еpithelial) Horse Hair and Dander Dog (hair and dander) Guinea Pig (epithelial) Goose (feathers) Dog (hair) Chicken (feathers) Duck (feathers) Turkey (feathers) Name of allergen Egg White Cow milk Сod Wheat flour Rye flour Barley flour Oats flour Corn flour Rice Sesamе Buckwheat flour Pea Peanut Soybean Epidermal allergens Food allergens

4 F15 White beans F16 Walnut F17 Hazelnut F20 Almond F23 Crab meat F24 Shrimp F25 Tomato F26 Pork F27 Beef F31 Carrot F33 Orange F34 Mandarin F35 Potato F37 Mussel F40 Tuna F41 Salmon F44 Strawberry F45 Baker s yeast F49 Apple F61 Cauliflower F67 Ovalbumin F75 Egg yolk F76 Alpha-lactalbumin F77 Beta-lactoglobulin F78 Caseine F79 Gluten F81 Cheese Cheddar F83 Chicken meat F84 Kiwi F85 Celery F87 Melon F92 Banana F93 Kakao F94 Pear

5 F95 F205 F206 F208 F210 F212 F216 F221 F245 F247 F259 F262 F254 F284 Peach Herring Mackerel Lemon Pineapple Shampynon Cabbage Coffee Whole Egg Honey Grapes Eggplant Plaice Turkey meat Tree pollen T1 Maple Acer negundo T2 Alder Alnus glutinosa T3 Birch Betula verrucosa T4 Hazel Corylus avellana Т5 Beech Fagus sylvatica T7 Oak Quercus robur Т8 Elm Ulmus americana Т11 Sycamore Platanus acerifolia Т12 Goat willow Salix caprea T14 Cottonwood Populus deltoides T15 European Ash Fraxinus excelsior Weed pollen W1 Ragweed Ambrosia elatior W6 Wormwood Artemisia vulgaris W7 Oxeye daisy Chrysanthemum leucanthemum W8 Dandelion medicinal Taraxacum vulgare W9 Plantain Plantago lanceolata

6 W10 Pigweed Chenopodium album W11 Prickly saltwort Salsola kali W12 Goldenrod Solidago virgaurea Meadow grasses pollen G2 Bermuda grass Cynodon dactylon G3 Orchard grass Dactylis glomerata G4 Tall Fescue Festuca elatior G5 Perennial ryegrass Lolium perenne G6 Timothy Phleum pratense G8 Kentucky bluegrass Poa pratensis G12 Crop rye Secale cereale Mold fungi M1 Fungal mold Penicillium notatum M2 Fungal mold Cladosporium herbarum M3 Fungal mold Aspergillus fumigatus M4 Fungal mold Mucor racemosus M5 Fungal mold Candida albicans M6 Fungal mold Alternaria alternata (tenius) Insects I1 Bee poison Bee Venom (Apis mellifera) I3 Wasp poison Wasp Venom (Vespula species) I6 Cockroach Blatella germanica C1 C204 K82 Рenicillin G Аmoxycillin Latex Medications Others List of biotinylated allergens (mixtures): Code Name of mixture ЕМ1 A mixture of feathers: Goose (E70), Chicken (E85), Duck (E86), Turkey (E89) ЕМ2 A mixture of еpithelial: Cat (E1), Dog (E2), Horse (E3), Guinea Pig (E6) НDМ1 House Dust Mixture: Penicillium notatum(m1), Aspergillus fumigatus(m3), Candida albicans(m5), Alternaria alternata(m6), D.pteronyssinus(D1), D.farina(D2), домашній пил(h1) НDМ2 House Dust Mixture:

7 НDМ3 НDМ4 ІМ1 ММ1 FM1 FM2 FM3 FM4 FM5 FM6 FM7 FM8 FM9 FM10 FM11 FM12 FM13 FM14 FM15 FM16 FM17 GМ1 GМ2 ТМ1 ТМ2 ТМ3 ТМ4 ТМ5 ТМ6 House Dust (H1), D.pteronyssinus(D1), D.farinae(D2), Cockroach (I6) A mixture of household allergens: D.pteronyssinus(D1), Cat еpithelial (E1), Aspergillus fumigatus(m3), Cockroach (I6) A mixture of household allergens: D.pteronyssinus(D1), D.farinae(D2), Cat еpithelial (E1), Dog еpithelial (E2) A mixture of insects: Bee (I1), Wasp (I3), Cockroach (I6) A mixture of mold fungi: Penicillium notatum(m1), Cladosporium herbarum(m2), Aspergillus fumigatus(m3), Mucor racemosus(m4), Candida albicans(m5), Alternaria alternate(m6) Food mixture (nuts): Peanut (F13), Walnut (F16), Hazelnut (F17), Almond (F20) Food mixture (seafood): Cod (F3), Crab meat (F23), Shrimp (F24), Mussel (F37) Food mixture (crops): Wheat (F4), Oats (F7), Corn (F8), Sesame (F10), Buckwheat (F11) A mixture of fish: Cod (F3), Salmon (F41), Herring (F205), Mackerel (F206), Plaice (F254) Food mixture (pediatric): Egg White (F1), Cow milk (F2), Cod (F3), Wheat (F4), Peanut (F13), Soybean (F14) Food mixture: Almond (F20), Kiwi (F84), Melon (F87), Banana (F92), Grapes (F259) Food mixture: Almond (F20), Tomato (F25), Orange (F33), Strawberry (F44), Kiwi (F84), Melon (F87), Banana (F92), Peach (F95) Food mixture: Egg White (F1), Cow milk (F2), Wheat (F4), Rye (F5), Corn (F8), Egg yolk (F75), Alpha-lactalbumin (F76), Betalactoglobulin (F77), Caseine (F78), Gluten (F79), Cheese Cheddar (F81) A mixture of vegetables: Pea (F12), White beans (F15), Tomato (F25), Carrot (F31), Potato (F35) A mixture of fruits: Orange (F33), Apple (F49), Banana (F92), Peach (F95) A mixture of fruits: Apple (F49), Banana (F92), Pear (F94), Peach (F95) A mixture of fruits: Kiwi (F84), Melon (F87), Banana (F92), Peach (F95), Pineapple (F210) A mixture of fruits: Strawberry (F44), Pear (F94), Lemon (F208), Pineapple (F210) Food mixture (cow milk): Alpha-lactalbumin (F76), Beta-lactoglobulin (F77), Caseine (F78) Food mixture (seafood): Cod (F3), Shrimp (F24), Mussel (F37), Tuna (F40), Salmon (F41) Food mixture (pediatric): Egg white (F1), Cow milk (F2), Cod (F3), Wheat (F4), Soybean (F14), Tomato (F25), Egg yolk (F75) Food mixture (crops): Wheat (F4), Barley (F6), Oats (F7), Corn (F8), Rice (F9) A mixture of meadow grasses pollen: Orchard grass (G3), Tall Fescue (G4), Perennial ryegrass (G5), Timothy (G6), Kentucky bluegrass (G8) A mixture of meadow grasses pollen: Bermuda grass (G2), Orchard grass (G3), Tall Fescue (G4), Perennial ryegrass (G5), Timothy (G6), Kentucky bluegrass (G8), Crop rye (G12) A mixture of tree pollen: Oak (T7), Elm (T8), Sycamore (T11), Goat willow (T12), Cottonwood (T14) A mixture of tree pollen: Alder (T2), Hazel (T4), Elm (T8), Goat willow (T12), Cottonwood (T14) A mixture of tree pollen: Maple (T1), Alder (T2), Birch (T3), Hazel (T4), Oak (T7), Sycamore (T11), Goat willow (T12), Cottonwood (T14) A mixture of tree pollen (early flowering): Alder (T2), Birch (T3), Hazel (T4), European Ash (T15) A mixture of tree pollen (late flowering): Maple (T1), Oak (T7), Goat willow (T12), Cottonwood (T14) A mixture of tree pollen: Maple (T1), Birch (T3), Hazel (T4), Oak (T7), Elm (T8), Goat willow (T12), Cottonwood (T14)

8 WМ1 WМ2 WМ3 WМ4 WМ5 WМ6 Ragweed (W1), Wormwood (W6), Pigweed (W10), Prickly saltwort (W11) Ragweed (W1), Wormwood (W6), Oxeye daisy (W7), Dandelion medicinal (W8), Goldenrod (W12) Wormwood (W6), Plantain (W9), Pigweed (W10), Prickly saltwort (W11), Goldenrod (W12) Ragweed (W1), Wormwood (W6), Plantain (W9), Pigweed (W10), Goldenrod (W12) Ragweed (W1), Wormwood (W6), Oxeye daisy (W7), Pigweed (W10), Goldenrod (W12) Ragweed (W1), Wormwood (W6), Oxeye daisy (W7), Dandelion medicinal (W8), Plantain (W9)