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R-Biopharm AG Product Overview Allergen Analysis 2011

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R-Biopharm AG

Product OverviewAllergen Analysis

2011

2R-Biopharm AG – Allergen Analysis 2011

Allergens

Allergen Lateral-Flow ELISA real-time PCR Enzymatic

Almond

Brazil Nut

Casein

Cashew Kernel

Celery

Coconut

Crustacean

Egg

Fish

Gliadin/Gluten

Glutamic Acid

Hazelnut

Histamine

ß-Lactoglobulin

Lactose

Lupine

Lysozyme

Macadamia nut

Milk

Mollusc

Mustard

Peanut

Pistachio

Sesame

Soya

Sulfite

Walnut

R-Biopharm‘s Test Kit Portfolio

3

Allergens

Advantages of ELISA:

• quantitative results using certified standards (e.g. NIST CRM)• unique method to dectect milk and egg protein• simple sample preparation (20 min) and test procedure (3 x 10 min)• possibility of using automates (e.g. Chemwell)• evaluation with the software RIDA®SOFT Win

RIDASCREEN®FAST TestsQuantify allergenic protein

bioavid Lateral Flow TestsSwab for on-site testing

SureFood® Allergenreal-time PCR

GlutenReaction Mix 1Store at -20°C

Lot No: 04449

SureFood® Allergenreal-time PCR

GlutenInhibitionControl Mix 2Store at -20°C

Lot No: 04449

SureFood® Allergenreal-time PCR

GlutenPositiveControl DNA 3Store at -20°C

Lot No: 04449

SureFood® Allergenreal-time PCR

GlutenTaqPolymerase 4Store at -20°C

Lot No: 04449

SureFood® Allergenreal-time PCR

Gluten

FDE 5Store at -20°C

Lot No: 04449

SureFood® TestsUniform sample preparation

Surface and hygiene control

Clean and controlled allergen production conditions are a prerequisite for allergen-free food products. Therefore, swabs within production sites should be carried out regularly with test strips from bioavid or RIDA®QUICK. No lab equipment is required and results from these immunochromatographic tests are available within 5 - 10 min.

Product testing

For food testing different analytical methods exist: ELISA and PCR. While an ELISA detects proteins; PCR is detecting DNA. These two methods are ideal for reciprocal confirmation of screening results.RIDASCREEN® ELISAs detect directly allergenic proteins using a microtiter-plate-photometer. SureFood® Allergen from Congen is based on real-time PCR. For sample preparation SureFood® PREP (S1012) is used to extract DNA.

Advantages of real-time PCR:

• robust, stable target molecule (DNA) in highly processed food samples• highly specific system with minimum tendency to cross reactions• sensitivity in “low ppm” range• one sample preparation (90 min) for 15 parameters • standardized handling and test procedure (1 - 2 hrs)• in development: real-time PCR allowing quantification

Your turn-key solution to ensure allergen free food

Allergen Analysis on Surfaces and in Foodwith highly specific and sensitive test kits using ready-to-use reagents

Even small traces of allergenic substances in food can provoke allergic reactions in sensitized persons. Therefore, monitoring of cross contaminations in raw materials and production lines as well as correct labelling of food products are an important part of quality control in the food industry.

4R-Biopharm AG – Allergen Analysis 2011

Allergens

Product Description No. of Tests/Amount Code No.Enzyme immunoassay for quantitative analysis

RIDASCREEN® Gliadin AOAC-RI certified Codex Alimentarius Method (Type 1)

Official R5 Mendez method: Sandwich ELISA to quan-tify prolamines from wheat, rye and barley in e.g. food declared as gluten-free. Sample extraction with R7006 or R7099 (not contained in the kit). Detection limit: 1.5 mg/kg (ppm) gliadin or 3 mg/kg (ppm) gluten

96 determinations Incubation time: 1 hr 30 min

R7001

RIDASCREEN®FAST Gliadin R5 sandwich ELISA to quantify prolamines from wheat, rye and barley in e.g. food declared as gluten-free. Sample extraction with R7006 or R7099 (not contained in the kit). Detection limit: 2 mg/kg (ppm) gliadin or 4 mg/kg (ppm) gluten

48 determinations Incubation time: 30 min

R7002

RIDASCREEN® Gliadin competitive (2nd generation)

R5 competitive ELISA to quantify potential toxic peptide sequences from prolamines from wheat, rye and barley in fermented and hydrolyzed food (e.g. beer, starch, starch syrup, malt extracts). The standard material is a hydrolysate (mixture of wheat, rye and barley); the results can be related to the limit values of the Codex Alimentarius. Detection limit: 1.36 mg/kg (ppm) Gliadin

96 determinations Incubation time: 40 min

R7021

Cocktail Solution Extraction solution for all e.g. heat treated food samples in conjunction with R7001 and R7002. The extraction with Cocktail Solution is the official recommended method (Mendez).

105 ml R7006

RIDA® Extraction Solution Alternative to the Cocktail Solution: The extraction is faster (35 min compared to 1 hr 50 min with the Cocktail). It is used for all e.g. heat treated samples in conjunction with R7001 and R7002. R7099 is also used for Casein extraction of bakery goods and sausages (see R4612).

105 ml R7099

Set of 3 Gliadin Assay Controls

Three control materials: 1 negative, 2 positive (homogenized flour samples)

3 x 1.5 g R7010

RIDASCREEN®FAST Milk Sandwich ELISA to quantify milk proteins (casein and ß-lactoglobulin) in food containing traces of milk components. The assay is calibrated to NIST SRM 1549 non fat milk powder. Detection limit: 0.7 mg/kg milk protein

48 determinations Incubation time: 30 min

R4652

RIDASCREEN®FAST Casein (2nd generation)

Sandwich ELISA to quantify casein in food containing traces of milk or casein/caseinates. Detection limit: 0.24 mg/kg (ppm) casein in ice cream, chocolate, beverages. Detection limit: 1.36 mg/kg (ppm) casein in bakery goods and sausages (extraction with R7099, not contai-ned in the kit)

48 determinations Incubation time: 30 min

R4612

RIDASCREEN®FAST ß-Lactoglobulin

Sandwich ELISA to quantify native and processed ß-lactoglobulin in food containing traces of milk or whey. Detection limit: 0.19 mg/kg (ppm) ß-lactoglobulin

48 determinations Incubation time: 30 min

R4902

RIDASCREEN® ß-Lactoglobulin

Competitive ELISA to quantify native and processed ß-lactoglobulin in hydrolyzed milk products (e.g. hypoallergenic baby food). Detection limit: 0.115 mg/kg (ppm) ß-lactoglobulin

96 determinations Incubation time: 2 hr 45 min

R4901

5

Allergens

Product Description No. of Tests/Amount Code No.Enzyme immunoassay for quantitative analysis

RIDASCREEN® FAST Ei/Egg Protein

Sandwich ELISA to quantify traces of egg in food. The assay is calibrated to NIST SRM 8445 whole egg powder. No cross-reactivity to chicken meat (raw and cooked). Detection limit: 0.27 mg/kg (ppm) whole egg powder

48 determinations Incubation time: 30 min

R6402

RIDASCREEN®FAST Lysozym

Sandwich ELISA to quantify traces of lysozyme in wine, cheese and sausage. Detection limit: 0.02 mg/kg (ppm) lysozyme

48 determinations Incubation time: 30 min

R6452

RIDASCREEN®FAST Peanut AOAC-RI certified

Sandwich ELISA to quantify traces of peanut in food. The assay is calibrated to NIST SRM 2387 peanut butter. Detection limit: 1.5 mg/kg (ppm) peanut

48 determinations Incubation time: 30 min

R6202

RIDASCREEN®FAST Hazelnut

Sandwich ELISA to quantify traces of hazelnut in food. Detection limit: 1.5 mg/kg (ppm) hazelnut

48 determinations Incubation time: 30 min

R6802

RIDASCREEN®FAST Mandel/Almond

Sandwich ELISA to quantify traces of almond in food. Detection limit: 1.7 mg/kg (ppm) almond

48 determinations Incubation time: 30 min

R6901

RIDASCREEN®FAST Senf/Mustard

Sandwich ELISA to quantify traces of mustard in food. The assay detects yellow, white, brown and black mustard. Detection limit: 0.22 mg/kg (ppm) mustard powder

48 determinations Incubation time: 30 min

R6152

RIDASCREEN®FAST Lupine Sandwich ELISA to quantify traces of lupin in food. Detection limit: 0.6 mg/kg (ppm) lupin protein

48 determinations Incubation time: 30 min

R6102

RIDASCREEN® Histamin Competitive ELISA to quantify histamine in food. Detection limit: 0.1 - 100 mg/kg (ppm) histamine depending on matrix

96 determinations 48 determinations Incubation time: 1 hr 15 min

R1601 R1604

RIDA®QUICK Histamin

Colourimetric assay to quantify histamine in fishmeal and fresh fish. Detection limit: 20 mg/kg (ppm) (fresh fish) Detection limit: 125 mg/kg (ppm) (fish meal)

48 determinations Incubation time: 5 min

R1603

RIDA® Sampling Tools for Swab Tests

Plastic tubes and swabs 100 of each Z0010

Test Strips (immunochromatographic tests)

RIDA®QUICK Gliadin The immunochromatographic test is based on the R5 antibody and detects prolamines from wheat, rye and barley. The strips can be used directly for swabs on surfaces or for analysis of e.g. gluten-free raw materials. Detection limit: 0.5 μg gliadin/100 cm2 on surfacesDetection limit: 2.5mg/kg (ppm) gliadin in e.g. gluten-free raw materials

25 strips Incubation time: 5 min

R7003

RIDA®QUICK Hazelnut Immunochromatographic test to detect traces of hazelnut in food e.g. chocolate. Detection limit: 5 mg/kg hazelnut

25 strips Incubation time: 10 min

R6803

RIDA®QUICK Peanut Immunochromatographic test to detect traces of peanut in food e.g. chocolate. Detection limit: 5 mg/kg peanut

25 strips Incubation time: 10 min

R6203

6R-Biopharm AG – Allergen Analysis 2011

Allergens

Product Description No. of Tests/Amount Code No.bioavid Diagnostics Lateral Flow Tests (immunochromatographic tests)

Coconut Qualitative detection of coconut Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL600-10 BL600-25

Almond Qualitative detection of almond Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL601-10 BL601-25

Brazil Nut Qualitative detection of brazil nut Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL602-10 BL602-25

Mustard Qualitative detection of mustard Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL603-10 BL603-25

Hazelnut Qualitative detection of hazelnut Detection limit: 5 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL604-10 BL604-25

Macadamia Nut Qualitative detection of macadamia nut Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL605-10 BL605-25

Peanut Qualitative detection of peanut Detection limit: 5 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL606-10 BL606-25

Walnut Qualitative detection of walnut+pecan nut Detection limit: 10 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 15 min

BL607-10 BL607-25

Egg Qualitative detection of egg Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL608-10 BL608-25

Sesame Qualitative detection of sesame Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL609-10 BL609-25

Cashew Kernel Qualitative detection of cashew kernel Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL610-10 BL610-25

Pistachio Qualitative detection of pistachio Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL611-10 BL611-25

Milk Qualitative detection of milk Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL613-10 BL613-25

Soy Qualitative detection of soy Detection limit: 1 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL615-10 BL615-25

Crustacean Qualitative detection of crustacean Detection limit: 10 mg/kg (ppm) depending on matrix

10 test strips 25 test strips Incubation time: 10 min

BL616-10 BL616-25

Combi Kit Individual 10 x combinations of above-named allergens 50 test strips Incubation time: 10 min

BLC6-50

bioavid Diagnostics Accessories

Swabbing Kit Kit for sampling of allergen residues in environmental surfaces (e.g. in food production lines) in combination with bioavid lateral flow test strips

25 swabs, vials, pipettes, 10 ml buffer concentrate

BS800-25

Absorption Buffer Buffer for preparation of polyphenol containing samp-les (e.g. coffee, red wine) for bioavid lateral flow kits

25 vials (9 ml buffer each)

BS810-25

7

Allergens

Product Description No. of Tests/Amount Code No.SureFood® PREP DNA Preparation

Allergen DNA preparation from foods 50 preparations S1012

SureFood® ALLERGEN Qualitative real-time PCR

Soya Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 2 ppm depending on matrix and DNA preparation

100 reactions* S3101

Hazelnut Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 2 ppm depending on matrix and DNA preparation

100 reactions* S3102

Peanut Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 2 ppm depending on matrix and DNA preparation

100 reactions* S3103

Almond Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 3 ppm depending on matrix and DNA preparation

100 reactions* S3104

Celery Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3105

Gluten Qualitative DNA detection for spelt, barley, oats, kamut, rye, wheat Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3106

Walnut Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3107

Sesame Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3108

Mustard Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 2 ppm depending on matrix and DNA preparation

100 reactions* S3109

Fish Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3110

Lupin Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3111

Crustaceans Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation . Cross reactivity with abalone

100 reactions* S3112

Molluscs Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3113

Pistachio Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 1 ppm depending on matrix and DNA preparation

100 reactions* S3114

Cashew Qualitative DNA detection Detection limit: < 5 DNA copies, ≤ 2 ppm depending on matrix and DNA preparation

100 reactions* S3115

* includes additional 100 reactions of Inhibition Control Mix (ICM)

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R-Biopharm AGAn der neuen Bergstraße 1764297 DarmstadtPhone: +49 (0) 61 51 - 81 02-0Fax: +49 (0) 61 51 - 81 [email protected]