ILSI Workshop Romer Labs Food Allergen Testing solutions

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1 Romer Labs Experts in food allergen testing ILSI Workshop Romer Labs Food Allergen Testing solutions 8/10 AgraQuant Plus ELISA kits 22 AgraQuant ELISA kits 19 AgraStrip LFD kits Bangkok April Lukas FRANK next generation monoclonal Gluten antibody ISO accredited service laboratory for allergen testing AgraQuant (Plus) Test kits ELISA Method Quantitative Results Lab equipment needed (Reader, centrifuge, water bath) 48 (some 96) microwells AgraStrip Test kits Lateral Flow Strip Method Qualitative Results On site testing - No Lab equipment needed (all components included) 10 test strips & swabs Allergen detection with the AgraStrip

2 Why using a strip test for allergens? Why using AgraStrip Allergen Kits? ü Real time testing implement decisions quickly ü Trouble shooting abilities ü Simplicity of use less training ü Cost effective - single sample ü No additional equipment for AgraStrip Allergen Tests ü On-site testing ü Confidence through testing ü everything included in kit (completely on-site method) ü same procedure (ex. G12, soy) ü Time To Result: 11min ü sensitive - Low LOD ü storage at Room Temperature ü Certificate of Performance ü Validation reports On-site Testing for Trace Amounts of Allergens 2 extraction procedures Finished Products & Rinse Water Testing - Extraction Homogenize the sample (i.e. blend, crush, grind) Weigh 0.2g of sample (with Balance or estimate by filling up one of the extraction tube caps) and add to an extraction tube or just add 0.2 ml rinse water Fill Extraction Tube with Extraction Buffer to level shown below (blue arrow) Close tube with tube cap, and shake vigorously by hand for 1 minute. Remove cap from the Extraction Tube and replace with dropper tip. And transfer 12 drops (400ml) to an incubation vial.

3 Fill extraction tube with Extraction Buffer, take a swab and wet the end by dipping into the buffer Swabbing - Extraction Wipe an area of 5cmx5cm using side to side movements, rotating the swab tip as you go (we recommend the cross-hatch swabbing technique indicated below) Place the swab into the extraction tube. Carefully break off the end at the pre-scored point. Running the Assay for all sample types Shake Incubation Vial vigorously by hand for 15 seconds (ensuring liquid comes in contact with the lid of the vial) then leave to stand at room temperature for 5 minutes. Open the container of AgraStrips, remove the necessary number of strips and close the tube. Open the Incubation Vial and dip the bottom end of test strip into the vial. Close the tube with a cap and shake vigorously for 1 minute Remove cap from the Extraction Tube and replace with dropper tip. And transfer 12 drops (400ml) to a new tube (incubation Vial) Remove the test strip from the Incubation Vial after 5 minutes and read off the result immediately. Reading Results Video AgraStrip Allergen Procedure One single purple line in the central part of the test = negative result Two purple lines in the result zone = positive result No control line appears = invalid result

4 AgraStrip Allergens (19) iphone app AgraStrip Peanut (COKAL0110AS) AgraStrip Egg (COKAL1810AS) AgraStrip Walnut (COKAL0910AS) AgraStrip Sesame (COKAL1910AS) AgraStrip Soy (COKAL0410AS) AgraStrip Hazelnut (COKAL0310AS) AgraStrip Gluten G12 (COKAL0200AS) AgraStrip Lupin (COKAL1510AS) AgraStrip Macadamia (COKAL1610AS) AgraStrip Milk (COKAL2610AS) AgraStrip Almond (COKAL0710AS) AgraStrip Casein (COKAL1210AS) AgraStrip Mustard (COKAL2110AS) AgraStrip Brazil Nut (COKAL1710AS) AgraStrip Coconut (COKAL2610AS) AgraStrip Cashew/Pistachio (COKAL1310AS) AgraStrip BLG (COKAL1010AS) AgraStrip Crustacea (COKAL1010AS) AgraStrip Gluten (COKAL0210AS) In the pipeline: Chickpea, Lysozyme, alpha-lactalbumin, Celery AgraApp iphone app iphone app send results to your AgraApp AgraApp

5 iphone app iphone app compatible with AgraStrip Brazil nut, Almond, Cashew, Hazelnut, Macadamia nut, Peanut, Pistachio, Walnut for the interpretation of solid samples View previous results results to your PC Re-order kits about RL: Press releases, News, FAQs additional helpful features included in the app Contact RL future updates (prerequisite sucess of the app): compability for the whole AS portfolio app for Android users AgraApp AgraApp Romer Labs Allergen AgraQuant test kits Allergen detection with the AgraQuant and AgraQuant Plus 8/10 AgraQuant Plus ELISA kits 22 AgraQuant ELISA kits

6 Abs. Romer Labs Allergen AgraQuant test kits AgraQuant Allergens (20) 1) EXTRACTION (different AQ vs AQ Plus) AgraQuant Peanut (COKAL0148) AgraQuant Hazelnut (COKAL0348) AgraQuant Almond (COKAL0748) 2) DETECTION (mainly sandwich ELISA) Microplates coated with specific antibody Antibody-enzyme conjugates Substrate changing color in presence of enzyme AgraQuant Egg white (COKAL0848) AgraQuant Walnut (COKAL0948) AgraQuant Sesame (COKAL1948) AgraQuant Gluten G12 (COKAL0200) AgraQuant Lupin (COKAL1548) AgraQuant Pistachio (COKAL2748) AgraQuant Casein (COKAL1200) AgraQuant Mustard (COKAL2148) AgraQuant Crustacea (COKAL2248) Conc. Microwell Capture Antibody Conjugate Detection Antibody Sample (Antigen) AgraQuant Soy (COKAL0448) AgraQuant Cashew (COKAL3148) AgraQuant Ovalbumin (COKAL2948) AgraQuant Milk (COKAL2448) AgraQuant BLG (COKAL1048) AgraQuant Gluten (COKAL0248) AgraQuant Fish (COKAL2548) AgraQuant Lysozyme (COKAL2848) AgraQuant Plus Allergens AgraQuant Plus Allergens AgraQuant Plus Egg (COKAL1848F) AgraQuant Plus Almond (COKAL0748F) AgraQuant Plus Peanut (COKAL0148F) AgraQuant Plus Macadamia nut (COKAL1648F) Washbuffer Stop solution AgraQuant Plus Hazelnut (COKAL0348F) AgraQuant Plus Casein (COKAL1248F) 5 standards Substrate Conjugate AgraQuant Plus Cashew (COKAL3148F) AgraQuant Plus Mustard (COKAL2148F) Launched next: Pistachio, Sesame In the pipeline: BLG, Lupin, Soy, Walnut, Chickpea, Brazil nut Antibody coated wells Transfer wells Extraction additive 1 &2

7 AgraQuant Plus Customer benefits Protect your business and your brand Avoid costly recalls Fast product release Accurate results protect your image Largest Allergen Portfolio: Complete product portfolio Simple ordering process Fast support and close customer relationship Unique extraction capsules optimize your workflow Reduce individual errors No costly trainings Extraction Procedures: 1.Food 2.Environmental samples (swab and sponge) 3.Rinse water Save time, efforts and money Increase productivity in your lab through fastest Allergen ELISA method on the market (1min extraction + 30min ELISA) Analyse same sample extract for several allergens Extraction procedure: ELISA Assay: 1. Accurately weigh 1g (ml) of sample into a 50mL centrifuge tube and add one capsule each of extraction addititve 1 & 2 2. Bring destilled water to C and Add 20mL hot, but not boiling water to the tube 8000g 5min 3. Shake tube vigorously for 15 seconds (until sample and capsules are dissolved) 4. Transfer an aliquot to a 1.5 or 2 ml reaction vial and centrifuge OR alternatively, filtrate through a pleated filter and use the filtrate in the test. Running the assay: 30 min

8 The big advantages: fast extraction of up to 24 samples at the same time but also the extracts of the normal AQ kits can be used in different assays no need for preparing extraction buffer one extract can be used to measure several allergens (exception egg) 10 vs 70 samples Gluten G12 The G12 monoclonal antibody is raised against the 33-mer: The next generation Gluten Antibody a 2 -gliadin fragment of 33 amino acids (56 88) in length was identified as the primary initiator of inflammatory responses in Coeliac Disease (Shan et al., 2002) Sequence of the immunotoxic 33-mer: (L = Leucin, Q = Glutamine, P = Proline, F = Phenylalanine, Y = Tyrosine) Shan et al., Science 2002; 297: Anderson et al., Nat Med 2000;6: Arentz-Hansen et al., J Exp Med 2000; 191:

9 Gluten G12 Analytical Service ISO 17025:2005 accredited through the American Association for Laboratory Accreditation for allergens for mycotoxins AgraQuant Gluten G12 AOAC Official Method AgraStrip Gluten G12 à For customized validation à For confirmation of positives ROMER LABS, INC Stylemaster Drive Union, MO Laboratory Director: Christy Brewe Phone: ISO17025:2005 ISO 9001: :2005 ISO 17025:2005 Romer Labs supports you with: ü Broad Range of Allergen Solutions ü Custom based validations ü Confirmation of positives ü Customer service ü Technical service/support ü Trainings and Certification ü Check Sample Surveys Romer offers solutions for the whole process! Analytical Service Ingredients Certification Covering all Stages In-Process Finished Products Cleaning Validation

10 Thanks for your attention! Questions?

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