AgraStrip Allergens - Lateral Flow Devices The AgraStrip Allergen Test Kits are immunological rapid test in lateral flow format for the detection of allergens in food, rinse waters and environmental swabs. Lateral flow devices are a very fast and easy to use on-site detection method for traces of food allergens. The AgraStrip tests form a system allowing on-site detection of multiple food allergens. Each Testkit includes*: Package Insert Certificate of Performance 10 strip tests in tube 1 Dropper Bottle containing 35 ml Extraction Solution 10 Extraction Tubes and Caps 10 Incubation Vials ready to use antibodies 10 Extraction Tube dropper tips 10 Swabs 1 stand for incubation vials AgraStrip Allergen Test Kits available: Kit Order number AgraStrip Peanut Kit COKAL0110AS AgraStrip Kit COKAL0210AS AgraStrip G12 Kit COKAL0225AS AgraStrip Hazelnut Kit COKAL0310AS AgraStrip Almond Kit COKAL0710AS AgraStrip Walnut Kit COKAL0910AS AgraStrip Casein Kit COKAL1210AS AgraStrip Cashew/Pistachio Kit COKAL1310AS AgraStrip Macadamia Nut Kit COKAL1610AS AgraStrip Brazil Nut Kit COKAL1710AS AgraStrip Egg Kit COKAL1810AS AgraStrip Sesame Kit COKAL1910AS AgraStrip Mustard Kit COKAL2110AS 06/2011, Romer Labs *Test kit composition and procedure for AgraStrip G12 varies.
Assay Principles Immunological rapid test in lateral flow format for the detection of allergens in food, rinse waters and swab (environmental ). The extracted sample is transferred to an incubation vial that contains specific ready-to-use antibodies. If the sample contains the allergen, an antigen-antibody complex will form. This is subsequently detected by means of the test strip. Resulting in a visible testline. Hook-Effect If more than 1% of allergen (10 000 ppm) is present in the sample then this can lead to a false negative result! Therefore the test is designed for detection of allergen traces. Sampling Consideration must be taken that the food may contain an uneven distribution of allergens (spot contamination). It is important to test a representative portion of food as only a small amount of material is the AgraStrip Allergen test. So far there are no official regulations on sampling for food allergen testing. One reason for this is the different nature of for food allergens as they can vary from solid, dry powders to viscous and liquid form. A different approach is necessary for each type of sample matrix. Affordablility and ease of use of the AgraStrip Allergen kits allow that more can be taken and than in the past. This helps to identify these hot spots of contamination, thereby also reducing some of the largest variances in testing which arise from sampling and reduce the potential risk to consumers of hidden food allergens. Swabbing The AgraStrip Allergen Kit contains swabs for environmental sample collection. Advantages performing AgraStrip Allergen tests Fast 11 minutes total (including extraction) Sensitive LOD in low ppm range (see validation data for more details) Stable 12 months shelf life at room temperature Cost Effective 10 single sample tests User friendly ready to use components including extraction buffer in kit, no additional equipment NOTE: Please consult Package Inserts for detailed procedures, as they might vary slightly. Most products of the AgraStrip Allergen Kit range were developed in cooperation ifp (www.produktqualitaet.com) Page 2
AgraStrip Allergens - Lateral Flow Devices 06/2011, Romer Labs Validation data of AgraStrip Allergen Test Kits - Overview Hazelnut Almond Walnut Casein Cashew/ Pistachio Macadamia Nut G12 Peanut Casein ( skimmed milk powder) 10 ppm Walnut Almond Hazelnut 3 ppm Cashew Pistachio Macadamian Nut Brazil Nut Brazil Nut Egg Sesame Mustard dried whole egg 4 ppm Peanut Limit of Detection pecan nuts and rye rye rye Sesame Mustard wheat flour and rye rye and barley slight pecan nut and walut reacts 33mer peptide, known to be the toxic fragment in gliadin Specificity slight green peas, white beans, soy beans 20-40 ppm walnut cashew ( cashew) 2- pistachio (9.4-23.5 ppm pistachio) 0.5- (5.5-21.8 ppm macadamia) (14. brazil nut) (2. dried whole egg) 0.5- (2.8-27. sesame) 2-20 ppm (6-60 ppm mustard) ( almond) (8 ppm hazelnut) 3 ppm (4 ppm peanut) LOD in spiked Commodities Rinse water (plastic) (stainless steel) 1 µg 20 µg walnut (plastic) 50 µg walnut (stainless steel) 4 µg Swabbing Recovery (plastic and stainless steel) Page 3
Comparison of AgraStrip Allergen on-site method Limits of detection on spiked (ppm) Peanut Hazelnut Almond Casein Egg (as whole dried egg) Romer Comp.* Romer Comp.* Romer Comp.* Romer Comp.* Romer Comp.* Romer Comp.* Yoghurt 4 20 5 > 10 8 40 5 5 2.5 > 12.5 Biscuit 4 8 5 1 2.5 Dairy free spread 4 > 20 5 > 10 8 >40 5 5 1 > 5 2.5 12.5 Chocolate 4 > 20 5 > 10 8 5 > 25 1 > 5 2.5 > 12.5 Curry Sauce 4 > 20 5 > 10 8 > 40 5 25 1 > 5 2.5 > 12.5 Sausage** 4 > 20 > 10 8 40 5 25 1 > 5 2.5 > 12.5 Rice Flour*** 4 5 > 10 8 40 5 25 5 > 12.5 No matrix 4 5 8 5 1 2.5 Competitor Comparison unable to detect in chocolate, dairy free spread, curry sauce and sausage unable to detect 10 ppm in yoghurt, dairy free spread, chocolate, curry sauce and rice flour unable to detect 5 ppm in dairy free spread and curry sauce, false positive seen chocolate unable to detect in chocolate and in curry sauce and sausage unable to detect 5 ppm in dairy free spread, chocolate, curry sauce and sausage unable to detect in yoghurt, curry sauce, chocolate sausage and rice flours *Competition **containing wheat ***containing egg Page 4
AgraStrip Allergens - Lateral Flow Devices Overview Cross of AgraStrip Test Kits 06/2011, Romer Labs Peanut G12 Sweet low fat milk powder - - - - - - + - - - - - - Low fat milk powder - - - - - - + - - - - - - Sweet whey powder - - - - - - + - - - - - - Whey concentrate (35%) - - - - - - + - - - - - - Whey concentrate (85%) - - - - - - + - - - - - - Cream powder (42%) - - - - - - + - - - - - - Cashew - - - - - - - + - - - - - Pecan nut - - - + - + - - - - - - - Macadamia - - - - - - - - + - - - - Sesame - - - - - - - - - - - + - Hazelnut - - - + - - - - - - - - - Sunflower seed - - - - - - - - - - - - - Walnut - - - + - + - - - - - - - Linseed - - - - - - - - - - - - - Almond - - - - + - - - - - - - - Pistachio - - - - - - - + - - - - - Brazil nut - - - - - - - - - + - - - Peanut + - - - - - - - - - - - - Pine kernel - - - - - - - - - - - - - Whole egg powder - - - - - - - - - - + - - Red lentil - - - - - - - - - - - - - Green peas + - - - - - - - - - - - - Wheat flour - + + - - - - - - - - - + Dark chocolate 20 ppm almond - - - - + - - - - - - - - Lupin - - - - - - - - - - - - - White beans + - - - - - - - - - - - - Chick peas - - - - - - - - - - - - - Oat - - - - - - - - - - - - - Rice flour - - - - - - - - - - - - - Apricot - - - - - - - - - - - - - Soybean + - - - - - - - - - - - - Barley - + + - - - - - - - - - - Rye - + + - - + - - + + - - + Corn - - - - - - - - - - - - - Hazelnut Almond Walnut Casein Cashew/Pistacio Macadamia Nut Brazil Nut Egg Sesame Mustard Page 5
AgraStrip Allergens - Lateral Flow Devices Related Romer Labs Food Allergen Products AgraQuant ELISA Kits I Item No. Product Quantitation Range Limit of Detection* COKAL0148 AgraQuant Peanut 1-40 ppm 0. COKAL0200 AgraQuant G12 4-200 ppm COKAL0248 AgraQuant 4-120 ppm 0.6 ppm COKAL0348 AgraQuant Hazelnut 1-40 ppm 0.3 ppm COKAL0448 AgraQuant Soy 40-1000 ppb 16 ppb COKAL0748 AgraQuant Almond 0.4-10 ppm 0. COKAL0848 AgraQuant Egg White 0.4-10 ppm 0.0 COKAL0948 AgraQuant Walnut 2-60 ppm 0.3 COKAL1048 AgraQuant ß-Lactoglobulin 10-400 ppb 1.5 ppb COKAL1200 AgraQuant Casein 0.2-6 ppm 0.04 ppm COKAL1548 AgraQuant Lupin 2-30 ppm 0. COKAL1948 AgraQuant Sesame 2-30 ppm 0. COKAL2148 AgraQuant Mustard 2-60 ppm COKAL2248 AgraQuant Crustacea 20-400 ppb 0.9 ppb *determined in buffer AgraQuant Allergen Swabbing Item No. Product COOLS0120 AgraQuant Allergen Swabbing Kit (20 swabs) >> IMPRINT published by Romer Labs Division Holding GmbH. Technopark 1, 3430 Tulln, Austria Tel: +43 2272 615331 0 Fax: +43 2272 615331 11 e-mail: marketing@romerlabs.com Editors: Hannes Binder, Alois Fellinger For further information, please contact Romer Labs or your respective Romer Labs distributor. Romer Labs, Inc. 1301 Stylemaster Drive Union, MO 63084-1156, USA Tel. +1 636 583 8600 Fax +1 636 583 6553 Mail office@romerlabs.com Romer Labs Diagnostic GmbH Technopark 1, 3430 Tulln, Austria Tel. +43 2272 615 3310 Fax +43 2272 615 33111 Mail office-europe@romerlabs.com Romer Labs Singapore Pte. Ltd. 3791 Jalan Bukit Merah #08-08, e-centre@redhill Singapore 159471 Tel. +65 6631 8018 Fax +65 6275 5584 Mail salesasia@romerlabs.com Page 6