R-Biopharm AG. Product Catalogue. Clinical Diagnostics. R-Biopharm for reliable diagnostics.

Transcription

1 R-Biopharm AG Product Catalogue Clinical Diagnostics 2014 R-Biopharm for reliable diagnostics.

2 R-Biopharm AG Product Catalogue

3 Introduction Editorial Page 4 Overview of R-Biopharm test systems Page 6 Allergy Diagnostics Introduction Page 8 Products Page 9-15 Infectious Diseases / Antigen Detection Introduction Page 16 Products Page Infectious Diseases / Antibody Detection Introduction Page 20 Products Page Molecular Diagnostics Introduction Page 26 Products Page Tumor Diagnostics Introduction Page 30 Products Page 31 Gastroenterology Introduction Page 32 Products Page 33 Instruments / Software / Accessories Introduction Page 34 Products Page 35 Vitamin Detection Page 35 R-Biopharm Contacts Page 37 General Terms of Sale and Delivery of R-Biopharm AG Page 38 3

4 R-Biopharm AG Comprehensive solutions from a single source reliable and approved R-Biopharm is a leading developer of test solutions for Clinical Diagnostics and Food & Feed Analysis. The high standards of R-Biopharm test solutions in both sectors are a requisite of high value, for both patient and consumer. R-Biopharm s future projects will offer further exciting prospects in the areas of Clinical Diagnostics and Food & Feed Analysis. The foremost challenge is to advance the development of new and versatile fast tests to enable our customers to answer a broad variety of analytical questions in a short period of time. Awards R-Biopharm has earned numerous awards for its business performance: Entrepreneur of the Year in 2004, 2005, and 2006, Technology Fast 50, a ranking of Germany s 50 fastest-growing companies in 2004, 2005 as well as Deloitte Sustained Excellence Award in 2012 and R-Biopharm worldwide Today, the German parent company R-Biopharm AG is represented by subsidiaries in USA, UK, France, Italy, Latin America*, Brazil*, China, Spain* and Australia as well as by a worldwide extensive network of more than 100 distributors. In addition, Switzerland*, Austria* and the Netherlands are represented by local sales managers. * Only Food & Feed Analysis R-Biopharm AG Product Catalogue

5 R-Biopharm History and Milestones employees 1988 Foundation by Röhm GmbH Darmstadt, Germany First products on the market distribution by Riedel de Haën Management buyout by Dr. Ralf M. Dreher Own distribution of Food & Feed Analysis Start distribution Clinical Diagnostics ISO 9001 and DIN EN Foundation R-Biopharm Inc. USA Merger with Innova Labordiagostik GmbH Worldwide exclusive distribution rights for the enzymatic BioAnalysis Testkits 91 of Roche Diagnostics 2001 Acquisition of Rhône Diagnostics Technologies Ltd (90 %) Foundation of R-Biopharm France Foundation of R-Biopharm Italia Srl Move to new facilities (Landwehrstraße, Darmstadt) ISO Foundation of R-Biopharm Analysis Systems Trading Co Ltd, China Acquisition of R-Biopharm Latinoamérica and R-Biopharm Brasil Ltda Acquisition of R-Biopharm España S.A. and R-Biopharm Australia Pty Ltd Foundation of bioavid Diagnostics GmbH Move to new facility (An der neuen Bergstraße, Darmstadt) Acquisition of Trilogy Analytical Laboratory (USA) and RefLab (Denmark) 400 Acquisition of CTL & Ortholabor GmbH Foundation of Evomed Diagnostics AG 2011 Acquisition of Central Testing Laboratory Ltd (Canada), 477 GWK Präzisionstechnik GmbH (Munich), CONGEN Biotechnologie GmbH and Humatrix AG Foundation of Biotech-Park Pfungstadt GmbH & Co. KG 2012 Acquisition of BIOSERV Diagnostics GmbH 514 Acquisition of Progen Biotechnik GmbH 2013 Opening of the Biotech-Park Pfungstadt R-Biopharm AG Headquarters Darmstadt 5

6 An overview of R-Biopharm test systems The products of both departments, Clinical Diagnostics as well as Food & Feed Analysis, have been designed and developed primarily for the immunoassay platform. Nonetheless, today there is also a great demand for other test formats like lateral flow tests, immunoblots, immunofluorescence assays, PCR or card tests. RIDASCREEN, RIDA and PentoCheck are worldwide registered trademarks of R-Biopharm AG. In Clinical Diagnostics R-Biopharm possesses many years of sound experience, particularly in the field of infectiological stool diagnostics but also in the field of serological infection diagnostics and allergy diagnostics. In 2006 the clinical product portfolio was extended by innovative test systems in the product lines tumor diagnostics and gastroenterology. R-Biopharm AG has been a successful market player worldwide and is constantly developing new and partly groundbreaking test systems in different areas. In this process automation is a main focus from the beginning. All R-Biopharm tests are validated and CE-marked. All products are not intended for use in diagnostic procedure in the US, except products marked FDA-cleared. R-Biopharm AG Product Catalogue

7 RIDASCREEN ELISA for antigen and antibody detection Ready-to-use reagents Simple realization of tests Standardized incubation period Possibility of processing on automated ELISA-systems Evaluation by the software RIDA SOFT Win RIDA QUICK 2 test formats Reliable rapid test for antigen detection High sensitivity and specificity Agents distinguished by color RIDA GENE Real-time PCR Contains all necessary components High sensitivity and specificity Can be run on commonly used real-time PCR instruments RIDA BLOT und RIDA LINE Western blots and Line blots for antibody detection Usage for the confirmation of positive results or in case of unclear findings by other serological methods Immunoblot (RIDA AllergyScreen ) for specific antibody detection (IgE) in serum RIDA FLUOR Immunofluorescence assays for antibody detection (IgG) in serum Test set consisting of slides, controls and reagents RIDA PentoCheck Highly specific primary mouse antibody for immunohistochemistry Directed against human transketolase-like 1 protein (TKTL1) 7

8 Allergy Diagnostics The use of different laboratory tests beside the anamneses and in-vivo tests are commonly accepted when investigating immediate-type allergies. R-Biopharm offers different laboratory tests for both IgE and IgG determination in human serum as well as histamine release assay. In-vitro diagnostics are frequently the only possibilities to confirm an atopic sensitization especially for children under the age of six, in case of suspected extreme sensibility and in patients with skin dermatosis in the testing area (neurodermitis, urticaria etc.). RIDASCREEN ELISA single and panel testing RIDASCREEN ELISA is an enzyme immunoassay for the detection of total/specific IgE and specific IgG antibodies. The system is based on a cellulose disc bound single allergen determination either in microwell plates or strips. R-Biopharm offers the allergen discs inserted in both 8-well breakable strips and 16-well solid microwell blocks (panel). With the possibility to order different individual panels, the high flexibility of single allergens is combined elegantly with the economic efficiency and the simple handling of the customized plate. R-Biopharm offers also customized plates assembled with allergen discs by R-Biopharm according to the client s order. This offers full flexibility in diagnostics, cost management and storage. RIDASCREEN spec. IgG Foodscreen The specific IgG Foodscreen is an enzyme immunoassay for the quantitative determination of specific IgG antibodies against food allergens and can be used in cases of suspected non-ige mediated food allergy. For more information please ask R-Biopharm AG or your local distributor. RIDA AllergyScreen panel testing RIDA AllergyScreen is an immunoblot especially designed for IgE mediated allergy screening purposes. With only 250 µl serum per panel 20 allergens can be tested simply and quickly in one work cycle, an efficient and highly economic system for the diagnostic confirmation of allergies. The evaluation of the panels is done either manually by comparing the bands with a color card or automatically by way of digital picture evaluation in the RIDA X-Screen or RIDA quadro-screen. Histamine-Release-Test (HR-Test) single and panel testing The HR-Test is an in-vitro method to detect allergen induced histamine release from basophil leukocytes by the use of a patented glass fiber method. As the HR-Test detects the symptom causing agent the histamine directly, it completes the present in-vitro allergy diagnostics. Allergy in vitro tests provided by R-Biopharm RIDA AllergyScreen spec. IgE screening test RIDASCREEN ELISA spec. IgE and IgG single test Histamine-Release-Test functional cellular allergy diagnostics R-Biopharm AG Product Catalogue

9 Allergy Diagnostics ELISA Single Allergen Format RIDASCREEN Allergen Disc Spec. IgE, Allergen Disc Spec. IgE, Reagents Spec. IgE, Reagents Spec. IgE, Set of Standards and Controls Total IgE Spec. IgG, Allergen Disc Spec. IgG, Reagents Spec. IgG, Reagents Enzyme immunoassay for antibody detection 1 allergen disc for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgE/IgG in serum Without reagents Order units: Allergy Basic (3 x 8-well strips per allergen) Allergy Advance (12 x 8-well strip per panel of 8 allergens) 1 allergen disc for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgE in serum Incl. Reagents Order units: Allergy Active (individually precoated plate; minimum number of allergens: 42) Set of reagents for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgE in serum Incl. standards and controls Set of reagents for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgE in serum Incl. standards and controls Set of 4 x 5 standards (each in double determination) and 4 x positive/negative controls for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgE in serum Sufficient for 4 approaches in double determination Enzyme immunoassay for the quantitative determination of circulating total-ige in serum Incl. standards and controls 1 allergen disc for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgG in serum Incl. Reagents Set of reagents for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgG in serum Incl. standards and controls Set of reagents for an enzyme immunoassay For the quantitative determination of circulating allergen-specific IgG in serum Incl. standards and controls 1 A A0249 A A A A A0629 A A0020 Accessories for RIDA AllergyScreen and RIDASCREEN Spec. IgE, Total IgE and Spec. IgG see: Instruments / Software / Accessories 9

10 Allergy Diagnostics ELISA Panel Format RIDASCREEN Spec. IgE, Allergy Panel 1, Atopy Spec. IgE, Allergy Panel 2, Inhalative Spec. IgE, Allergy Panel 3, Food Spec. IgE, Allergy Panel 4, Pediatric Spec. IgE, Allergy Panel, Customized* Spec. IgG, Allergy Panel, Customized* Enzyme immunoassay for antibody detection Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgE in serum 10 panels with 16 atopical allergens each Incl. reagents Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgE in serum 10 panels with 16 respiratory allergens each Incl. reagents Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgE in serum 10 panels with 16 food allergens each Incl. reagents Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgE in serum 10 panels with 16 pediatric allergens each Incl. reagents Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgE in serum 10 panels with 16 customized allergens each Incl. reagents Enzyme immunoassay for the quantitative determination of circulating allergen-specific IgG in serum 10 panels with 16 customized allergens each Incl. reagents 10 A A A A A A0630 * Minimum order of customized panels is 10 kits R-Biopharm AG Product Catalogue

11 Allergy Diagnostics Immunoblots RIDA Immunoblots for antibody analysing AllergyScreen Panel 1 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum 7 food allergens / 13 respiratory allergens Test membranes (nitrocellulose membrane) in reaction troughs AllergyScreen Panel 2 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum 20 respiratory allergens Test membranes (nitrocellulose membrane) in reaction troughs AllergyScreen Panel 3 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum 20 food allergens Test membranes (nitrocellulose membrane) in reaction troughs AllergyScreen Panel 4 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum 20 allergens / pediatric panel Test membranes (nitrocellulose membrane) in reaction troughs 10 A A A A2442 Individual panals on request. Please ask your local distributor Solution for automatisation available, please ask the local distributor Accessories for RIDA AllergyScreen and RIDASCREEN Spec. IgE, Total IgE and Spec. IgG see: Instruments / Software / Accessories 11

12 Allergy Diagnostics Delayed Food Allergy Diagnostics RIDASCREEN Spec. IgG Foodscreen Starter Kit Spec. IgG Foodscreen Customized Plate** Spec. IgG Foodscreen Plate 1 Spec. IgG Foodscreen Plate 2 Spec. IgG Foodscreen Plate 3 Spec. IgG Foodscreen Plate 6 Spec. IgG Foodscreen Prescreen 1 Spec. IgG Foodscreen Prescreen Customized** Enzyme immunoassay for detection of spec. IgG against food Enzyme immunoassay for the determination of circulating allergen-specific IgG Quantitative determination of specific IgG against food allergens Kit includes Spec. IgG Foodscreen, Plate 1-3 à 5 plates 1 plate is designed for 1 patient Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Quantitative determination of specific IgG against food allergens Up to 91 allergens per plate 1 plate is designed for 1 or more patients Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Quantitative determination of specific IgG against 90 common food allergens 1 plate is designed for 1 patient Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Quantitative determination of specific IgG against 90 common alternative food allergens 1 plate is designed for 1 patient Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG Quantitative determination of specific IgG against 91 rare food allergens and spices 1 plate is designed for 1 patient Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Quantitative determination of specific IgG against 44 food allergens 1 plate is designed for 2 patients Without reagents* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Semi-quantitative determination of specific IgG against 22 common food allergens for screening purposes 1 plate is designed for 4 patients Incl. Cut-Off control* Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum Semi-quantitative determination of specific IgG against up to 23 food allergens for screening purposes 1 plate is designed for 4 patients Incl. Cut-Off control* 15 plates / capillary 510 plates / capillary 15 plates / capillary 15 plates / capillary 15 plates / capillary 15 plates / capillary 15 plates / capillary 510 plates / capillary A8021 A8101 A A A A A8921 A8931 * Required set of reagents: A8020. Please see Accessories Foodscreen ** Minimum order is 510 plates R-Biopharm AG Product Catalogue

13 Allergy Diagnostics Delayed Food Allergy Diagnostics RIDASCREEN Spec. IgG Foodscreen Reagents Foodscreen Blood Collection Kit Foodscreen Blood Collection Card Foodscreen Elution buffer Accessories for Foodscreen Set of reagents for an enzyme immunoassay for the determination of circulating allergenspecific IgG in serum Sufficient for 15 plates Tool for collection and transport of human capillary sample Kit includes 1 Blood Collection Card, 2 lancets, 2 bandages, 2 alcohol swabs 1 Kit is designed for 1 patient Tool for collection and transport of human capillary sample Kit includes 100 Blood Collection Cards 1 Card is designed for 1 patient 100 ml of elution buffer to eluate capillary from the Blood Collection Card Accessory for A8025 and A8025-BCC 3.5 ml are needed for one circle of the Blood Collection Card filled with capillary 1 Set of reagents / capillary 1 Capillary 100 Capillary Capillary A8020 A8025 A8025-BCC A8025-EB 13

14 Allergy Diagnostics Cellular Allergy Diagnostics Plate format INHALATION PANEL Plate format FOOD PANEL Plate format DERMA PANEL Plate format FOOD ASIA PANEL Plate format INHALATION ASIA PANEL Plate format CUSTOMER DESIGNED Plate format CUSTOMER MATERIAL Plate format HISTAMINE Fluorometric detection of basophil histamine release Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 respiratory allergens in 6 diff. concentrations Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 food allergens in 6 diff. concentrations Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 dermatological related allergens in 6 diff. concentrations Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 food allergens in 6 diff. concentrations Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 respiratory allergens in 6 diff. concentrations Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and 10 customized allergens Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with histamine standards and anti-ige For the usage of own prepared allergens Incl. reagents and preparation vials (IL-3) Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and histamine standard Incl. reagents FOR REASEARCH PURPOSES ONLY! 10 Heparinized 10 Heparinized 10 Heparinized 10 Heparinized 10 Heparinized 10 Heparinized 10 Heparinized 10 Heparinized RLA212- INH RLA213- FOOD RLA214- DER RLA223- FOOD RLA222- INH RLA800-CD RLA211-CM RLA210 Plate format QUANTITATIVE HISTAMINE DETECTION* Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers and histamine standards (7) Incl. reagents 10 Heparinized RLA218 FOR REASEARCH PURPOSES ONLY! Plate format FIBER Fluorescence assay for allergen induced histamine release from human basophils Microtiter plates coated with glassfibers Incl. reagents 10 Heparinized RLA200 FOR REASEARCH PURPOSES ONLY! R-Biopharm AG Product Catalogue

15 Allergy Diagnostics Cellular Allergy Diagnostics Strip format VARIOUS ALLERGENS** Strip format VARIOUS ALLERGENS** Strip format CUSTOMER MATERIAL Strip format CUSTOMER MATERIAL Preparation vial HR-Test Reagent Kit HISTAREADER Fluorometric detection of basophil histamine release Fluorescence assay for allergen induced histamine release from human basophils 8-well strips coated with glassfibers and 1 allergen** 1 allergen** in 4 concentrations Histamine standard and anti-ige Incl. reagents and preparation vials (IL-3) Immunofluorescence assay for allergen induced histamine release from human basophils 8-well strips coated with glassfibers and up to 10 allergens** 120 strips/kit and up to 10 different allergens a 12 strips/kit Histamine standard and anti-ige Incl. reagents (Please remember to order min. 10 of art. no. RLA500) Immunofluorescence assay for allergen induced histamine release from human basophils 8-well strips coated with glassfibers, histamine standards and anti-ige For the usage of own prepared allergens Incl. reagents and preparation vials (IL-3) Immunofluorescence assay for allergen induced histamine release from human basophils 8-well strips coated with glassfibers, histamine standards and anti-ige For the usage of own prepared allergens Incl. reagents (Please remember to order min. 10 of art. no. RLA500) IL-3 coated preparation vial for activation of human basophil histamine release**** For detection of released histamine Necessary only in combination with a HISTAREADER Sufficient for 10 plates 5 Heparinized 120 Heparinized 5 Heparinized 120 Heparinized RLA- Xxxx*** RLA120 RLA5CM RLA120CM 5 RLA RLA700 * Available soon ** For available allergens please ask R-Biopharm AG *** For detailed art. no. please ask R-Biopharm AG **** Minimum order = 10 kits (= 50 vials) 15

16 Infectious Diseases / Antigen Detection Infections of the gastrointestinal tract belong to the most common diseases of our modern society. In the industrialized nations they are by now the second frequent disease in childhood. The diagnostics of infectious intestinal diseases belongs to the most frequent requirements in a medical microbiological lab. Knowledge of pathogenesis, epidemiology and diagnostics of these diseases has grown considerably over the last years, along with the list of possible agents. Besides the classical methods of microbiology, immunological tests like ELISA and immunochromatographic rapid tests play an increasingly important role in the microbiological lab. Their advantage over culturing methods is the possibility of detecting also those germs that are no longer able to multiply. Usually, an infection caused by enteropathogenic microorganisms disturbs the normal barrier function of the intestinal mucosa, however normally only temporarily. Such enteropathogenic species are found among bacteria, viruses and protozoans. As far as infants are concerned, Rotaviruses are among the most important causes of infectious enteritis. In addition to Astro- and Adenoviruses, Norovirus in particular plays an important role among those viral agents as it cannot be cultivated. Among the protozoans, Giardia lamblia, Entamoeba histolytica and Cryptosporidia are the most important causative agents of diarrhoea. As far as bacteria are concerned, Campylobacter causes by now just as many diseases as Salmonella, besides a large number of other pathogenic bacteria species. R-Biopharm offers a wide range of test kits for the specific detection of antigens of the different pathogenic agents in stool specimens. The ELISA systems are available under the trade name RIDASCREEN, the immunochromatographic rapid tests under the trade name RIDA QUICK respectively. The rapid tests are offered as dipsticks as well as in the practical cassette format. Available parameters for the detection of: Bacteria Campylobacter Clostridium difficile GDH (Glutamat dehydrogenase) E. coli O157 Toxins Clostridium difficile Toxin A/B Clostridium perfringens Enterotoxin Verotoxins (Shigatoxins) Parasites Cryptosporidium Entamoeba Giardia Viruses Adenovirus Astrovirus Norovirus Rotavirus R-Biopharm AG Product Catalogue

17 Infectious Diseases / Antigen Detection ELISA RIDASCREEN Adenovirus Astrovirus Campylobacter Enzymee immunoassays for antigen detection Enzyme immunoassay for the detection of Adenoviruses Enzyme immunoassay for the detection of Astroviruses Enzyme immunoassay for the detection of Campylobacter Clostridium difficile GDH Enzyme immunoassay for the detection of glutamate dehydrogenase of Clostridium difficile Clostridium difficile Toxin A/B Clostridium perfringens Enterotoxin Cryptosporidium Entamoeba Giardia Norovirus Rotavirus Verotoxin Enzyme immunoassay for the detection of toxin A and B of Clostridium difficile Enzyme immunoassay for detection of enterotoxin of C. perfringens Enzyme immunoassay for the detection of Cryptosporidium parvum and Cryptosporidium hominis Enzyme immunoassay for the detection of Entamoeba histolytica/dispar Enzyme immunoassay for the detection of Giardia lamblia Enzyme immunoassay for the detection of Noroviruses Enzyme immunoassay for the detection of Rotaviruses Enzyme immunoassay for the detection of verotoxins 1 and 2 (Shigatoxins 1 and 2) of E. coli bacteria stool C1001 stool C1301 stool C2401 stool C0701 stool C0801 stool C0601 stool C1201 stool C1701 stool C1101 stool C1401 C1401US* stool C0901 stool mtsb- Bouillon C2201 * Only for sale in US Please contact R-Biopharm AG for automatic solution RIDA Enrichment broth mtsb-bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria Z1000 Z

18 Infectious Diseases / Antigen Detection Rapid RIDA QUICK Campylobacter Clostridium difficile GDH Clostridium difficile Toxin A/B Cryptosporidium Rapid assays for antigen detection Single pouched cassettes immunochromatographic Lateral flow rapid assay for the detection of Campylobacter Single pouched cassettes immunochromatographic Lateral flow rapid assay for the detection of GDH Single pouched cassettes immunochromatographic Lateral flow rapid assay for the detection of toxins A and B Box with strips immunochromatographic rapid assay for the detection of Cryptosporidium parvum and Cryptosporidium hominis 25 stool N stool N stool N stool N1202 Cryptosporidium Single pouched cassettes 20 stool N1203 Cryptosporidium/ Giardia Combi Cryptosporidium/ Giardia Combi Cryptosporidium/ Giardia/Entamoeba Combi Cryptosporidium/ Giardia/Entamoeba Combi Entamoeba Box with strips immunochromatographic rapid assay for the detection of Cryptosporidium parvum, Cryptosporidium hominis and/or Giardia lamblia 25 stool N1122 Single pouched cassettes 20 stool N1123 Box with strips immunochromatographic rapid assay for the detection of Cryptosporidium and/or Giardia and/or Entamoeba 25 stool N1722 Single pouched cassettes 20 stool N1723 Box with strips immunochromatographic rapid assay for the detection of Entamoeba histolytica and Entamoeba dispar 25 stool N1702 Entamoeba Single pouched cassettes 20 stool N1703 Giardia Box with strips immunochromatographic rapid assay for the detection of Giardia lamblia 25 stool N1102 Giardia Single pouched cassettes 20 stool N1103 Norovirus Rotavirus Single pouched cassettes immunochromatographic Lateral flow rapid assay for the detection of Noroviruses Box with strips immunochromatographic rapid assay for the detection of Rotaviruses 25 stool N stool N0902 Rotavirus Single pouched cassettes 20 stool N0903 Rotavirus/Adenovirus Combi Rotavirus/Adenovirus Combi Verotoxin/0157 Combi Verotoxin/0157 Combi Box with strips immunochromatographic rapid assay for the detection of Rotaviruses and/or Adenoviruses 25 stool N1002 Single pouched cassettes 20 stool N1003 Box with strips immunochromatographic rapid assay for the detection of verotoxins and/or E. coli O mtsb- Bouillon Single pouched cassettes 20 mtsb- Bouillon N2202 N2203 R-Biopharm AG Product Catalogue

19 Infectious Diseases / Antigen Detection Controls RIDA Enrichment broth mtsb-bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria Controls for RIDA QUICK Rapid assays 25 Z1003 Campylobacter Positive control 1.8 ml NP2404 Clostridium difficile Toxin A/B Clostridium difficile GDH Positive control 1.8 ml NP0804 Positive control 1.8 ml NP0704 Norovirus Positive control 1.8 ml NP1404 Parasite Combi Control Rotavirus/Adenovirus Combi Control Verotoxin/O157 Combi Control Positive control 1.8 ml NP1704 Positive control 1.8 ml NP1904 Positive control 1.8 ml NP2204 Accessories for RIDASCREEN and RIDA Antigen Detection tests see: Instruments / Software / Accessories RIDA QUICK Sample diluent for stool specimens Sample diluent tubes with 1.5 ml sample diluent 25 stool ZN

20 Infectious Diseases / Antibody Detection Requirements for the modern serological diagnostics. The R-Biopharm test systems for infectious diseases cover all important areas of modern serological diagnostics. All test kits are highly specific and sensitive for the respective pathogens. RIDASCREEN Sero ELISA: Individual patient analysis leads to multiple determinations which must be tested in parallel. Test specific reagents and different incubation times require an amount of time and work that can hardly be handled. In our RIDASCREEN Sero ELISA product group the number of reagents is reduced to a minimum by offering common buffers and conjugates. Identical incubation times also make the simultaneous analysis of different tests easier. Thus, RIDASCREEN Sero ELISA fulfil the essential requirements for an automatic processing on modern ELISA systems that help to facilitate procedures in the laboratory. A single-point calibration of the standard curve reduces the number of standards to a single one and therefore keeps costs to a minimum. Interpretation of results is quick and easy by using RIDA SOFT Win.net software. For international comparability of the test results, R-Biopharm uses WHO-standards for several parameters (IU/ml). In addition to the RIDASCREEN Sero ELISA product line, R-Biopharm offers three more groups for infectious serological diagnostics: RIDASCREEN ELISA for Chlamydia diagnostics: Identification of species-specific antibodies is the decisive factor in the diagnosis of Chlamydia. The high cross reactivity of most antigens poses an immense problem for this diagnostic test. Only certain components of the outer membrane protein complex allow the differential identification of antigens RIDASCREEN ELISA for parasite diagnostics: R-Biopharm offers six ELISAs for the most important serological parameters in parasitology. To ensure quality of antibody detection in parasite diagnostics the selection of appropriate antigens is crucial. against C. trachomatis and C. pneumoniae. By using these proteins in the RIDASCREEN ELISA we offer highly specific tests for Chlamydia diagnostics. Common reagents and incubation times allow simultaneous analysis of these parameters that are of high importance for infectious serology. Therefore, we place a special focus on the selections of antigens used in our RIDASCREEN ELISA for parasite diagnostics. Also in this product line, all tests share common buffers and incubation times. PROGEN ELISA: R-Biopharm offers 5 highly specific and sensitive Progen ELISA for the diagnosis of Hantavirus, Haemophilus influenzae type B and Tick-borne Encephalitis. Enzyme immunoassays for the detection of: Respiratory tract infections: Adenovirus, Bordetella, Chlamydophila pneumoniae, EBV (VCA, EBNA), Influenza A, Influenza B, Mycoplasma pneumoniae, Parainfluenza 1 2 3, RSV Parasitic infections: Entamoeba histolytica, Taenia solium (cysticercosis), Echinococcus, Leishmania, Toxocara, Trichinella Herpes virus infections: EBV (VCA, EBNA), HSV 1, HSV 2, HSV 1+2, VZV Child diseases: Bordetella, Measles virus, Mumps virus, Parvovirus B19, VZV Sexually transmitted diseases: Chlamydia trachomatis, HSV 1, HSV 2, HSV 1+2 Grave infections in pregnancy: HSV 1, HSV 2, HSV 1+2, Parvovirus B19, VZV Zoonosis: Borrelia burgdorferi, Taenia solium (cysticercosis), Echinococcus, Leishmania, Toxocara, Trichinella Gastrointestinal infections: Helicobacter pylori, Entamoeba histolytica Vaccination control: Diphtheria, Tetanus, VZV R-Biopharm AG Product Catalogue Fungal infection: Candida albicans

21 Infectious Diseases / Antibody Detection Sero ELISA RIDASCREEN Adenovirus lga Adenovirus lgg Bordetella lga Bordetella lgg Bordetella lgm Bordetella PT IgA Bordetella PT lgg Borrelia lgg Borrelia lgm Candida lga Candida lgg Candida lgm Diphtherie lgg EBV EBNA lgg EBV VCA lgg EBV VCA lgm Helicobacter lga Helicobacter lgg HSV 1 lgg (glycoprotein G1) HSV 1 lgm (total antigen) HSV 2 lgg (glycoprotein G2) HSV 2 lgm (total antigen) HSV 1+2 lgg (total antigen) HSV 1+2 lgm (total antigen) Influenza A lga Influenza A lgg Influenza B lga Influenza B lgg Enzyme immunoassays for antibody detection Enzyme immunoassays for specific detection of IgA or IgG antibodies against Adenoviruses. The test can be used for the detection of antibodies against the different subtypes Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Bordetella pertussis and Bordetella parapertussis. Differentiation between infections and immune status after vaccination Enzyme immunoassays for specific detection of IgA or IgG antibodies against toxin of Bordetella pertussis Enzyme immunoassays for specific detection of IgG or IgM antibodies against Borrelia burgdorferi sensu lato Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Candida albicans and other antigenetically related Candida species Enzyme immunoassay for specific detection of IgG antibodies against the diphtheria toxoid. Differentiation between infections and immune status after vaccination. Analysis in international units (IU/ml) Enzyme immunoassay for specific detection of IgG antibodies against the Epstein-Barr-Virus nuclear antigen (EBNA) of Epstein-Barr-Virus (EBV). Documentation of the transition to the state of latency under use of EBNA-1 Enzyme immunoassays for specific detection of IgG or IgM antibodies against structure proteins (VCA = virus capsid antigen) of the Epstein-Barr- Virus (EBV) Enzyme immunoassays for specific detection of IgA or IgG antibodies against Helicobacter pylori Enzyme immunoassays for specific detection of IgG and IgM antibodies against the Herpes- Simplex-Viruses (HSV) type 1 and type 2. Detection of type-specific IgG antibodies by use of glycoprotein G (gg). Recombinant gg1 of HSV 1 and purified gg2 of HSV 2. Differentiation between a primary infection (IgG antibody negativ) and a recurrence (IgG antibody positive) Screening tests for specific detection of IgG or IgM antibodies against Herpes-Simplex-Viruses type 1 and type 2 (HSV 1, HSV 2) Enzyme immunoassays for specific detection of IgA or IgG antibodies against Influenza viruses of type A or B K1011 K1021 K2511 K2521 K2531 K2611 K2621 K3221 K3231 K9011 K9021 K9031 K3821 K6621 K6721 K6731 K2311 K2321 K5121 K5131 K5221 K5231 K5021 K5031 K6311 K6321 K6411 K

22 Infectious Diseases / Antibody Detection Sero ELISA RIDASCREEN Masern/Measles Virus lgg Masern/Measles Virus lgm Mumps Virus lgg Mumps Virus lgm Mycoplasma pneumoniae lga Mycoplasma pneumoniae lgg Mycoplasma pneumoniae lgm Parainfluenza 1, 2, 3 lga Parainfluenza 1, 2, 3 lgg Parvovirus B19 lgg Parvovirus B19 lgm RSV lga RSV lgg RSV lgm Tetanus lgg VZV lga VZV lgg VZV lgm Enzyme immunoassays for antibody detection Enzyme immunoassays for specific detection of IgG or IgM antibodies against Measles virus. IgG-analysis in international units (miu/ml) Enzyme immunoassays for specific detection of IgG or IgM antibodies against Mumps virus Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Mycoplasma pneumoniae Screening test for specific detection of IgA or IgG antibodies against Parainfluenza viruses of type 1, 2 and 3 Enzyme immunoassays for specific detection of IgG or IgM antibodies against Parvovirus B19 Detection of antibodies against recombinant VP1 and VP2. Differentiation between acute and past infection with Parvovirus B19 IgG-analysis in international units (IU/ml) Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Respiratory Syncytial Virus (RSV) Enzyme immunoassay for specific detection of IgG antibodies against the tetanus toxoid. Analysis in international units (IU/ml) Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Varicella-Zoster-Virus (VZV). Use of purified glycoprotein for IgG-detection IgG-analysis in international units (miu/ml) K5421 K5431 K5521 K5531 K4311 K4321 K4331 K5811 K5821 K6021 K6031 K5911 K5921 K5931 K3721 K5611 K5621 K5631 Please contact R-Biopharm AG for automatic solutions Also see: Instruments / Software / Accessories R-Biopharm AG Product Catalogue

23 Infectious Diseases / Antibody Detection Parasite diagnostics RIDASCREEN Echinococcus lgg Entamoeba histolytica IgG Leishmania Ab Taenia solium lgg Toxocara lgg Trichinella lgg Enzyme immunoassays for antibody detection Enzyme immunoassay for specific detection of IgG antibodies against Echinococcus granulosus and Echinococcus multilocularis Enzyme immunoassay for specific detection of IgG antibodies against Entamoeba histolytica Enzyme immunoassay for specific detection of IgG antibodies against Leishmania Enzyme immunoassay for specific detection of IgG antibodies against the larval forms of Taenia solium (cysticercosis) Enzyme immunoassay for specific detection of IgG antibodies against Toxocara canis Enzyme immunoassay for specific detection of IgG antibodies against Trichinella spiralis K7621 K1721 K7121 K7721 K7421 K7521 Chlamydia diagnostics RIDASCREEN Chlamydia IgG/IgM Chlamydia trachomatis IgA Chlamydia trachomatis IgG/IgM Chlamydophila pneumoniae lga Chlamydophila pneumoniae lgg Chlamydophila pneumoniae lgm Enzyme immunoassays for antibody detection Enzyme immunoassay for specific detection of IgG or IgM antibodies against LPS antigen (LPS = lipopolysaccharide) of Chlamydia Enzyme immunoassay for specific detection of IgA, IgG or IgM antibodies against outer membrane protein complex (COMP = Complexes of Outer Membrane Proteins) of Chlamydia trachomatis Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against outer membrane protein complex (COMP = Complexes of Outer Membrane Proteins) of Chlamydophila pneumoniae KGM3101 K2911 KGM2901 K2811 K2821 K2831 Please contact R-Biopharm AG for automatic solutions Also see: Instruments / Software / Accessories 23

24 Infectious Diseases / Antibody Detection PROGEN ELISA IMMUNOZYM FSME (TBE) IgG IMMUNOZYM FSME (TBE) IgM IMMUNOZYM HiB IgG Hantavirus (Puumala) IgG/IgM Hantavirus Dobrava / Hantaan IgG/IgM Enzyme immunoassays for antibody detection Enzyme Immunoassay for the specific detection of IgG or IgM antibodies against the TBE Virus Enzyme immunoassay for the specific detection of IgG antibodies against polyribosylribitolphosphate (PRP) of Haemophilus influenzae type B Enzyme immunoassay for the specific detection of IgG and IgM antibodies against the Puumala serotype of Hantavirus Enzyme immunoassay for specific detection of IgG- und IgM-antibodies against Hantavirus Dobrava and Hantaan serotypes of Hantavirus / Plasma/ CSF / Plasma K1621 K1631 K1821 KGM6901 KGM6801 Accessories for RIDASCREEN and RIDA Antibody Detection tests Enzyme immunoassays for antibody detection RF-Absorbens Anti-human IgG for absorption of rheumatoid factors (RF) and IgG antibodies in human serum or plasma 50 Z0202 R-Biopharm AG Product Catalogue

25 Infectious Diseases / Antibody Detection Western blots and Line blots for specific antibody detection RIDA BLOT and RIDA LINE Western blots and Line blots Helicobacter lga Helicobacter lgg Parvovirus B19 lgg Parvovirus B19 lgm Parvovirus B19 lgg / IgM Line blots for specific detection of IgA or IgG antibodies against Helicobacter pylori with recombinant antigens. Differentiation between Helicobacter pylori type I and II Line blots for specific detection of IgG or IgM antibodies against Parvovirus B19 with prokaryotic and eukaryotic recombinant antigen. World-wide distributed, except for USA, Canada, Australia and Israel. Line blots allow differentiation between acute and past infection with Parvovirus B19. Indicative for a probably persistent Parvovirus B19 infection Western blot for specific detection of IgG or IgM antibodies against Parvovirus B19 with prokaryotic recombinant antigens LB2313 LB2323 LB6023 LB L6003 Aviditätsreagenz for avidity testing in Line blots 25 LB0023 Immunofluorescence assays for antibody detection RIDA FLUOR Legionella IgG Negative control Legionella IgG Positive control Legionella IgG Slides (3 Pools) RIDA FLUOR Legionella lgg (3 Pools) Controls for immunofluorescence assays Negative control IgG 0.2 ml I8521C00 Positive control IgG 0.2 ml I8521C01 Slides for immunofluorescence assays Row 1: SG 1-6 Row 2: SG 7-14 Row 3: L. boz-dum-gor-jord-longb-mic Immunofluorescence assays Row 1: SG 1-6 Row 2: SG 7-14 Row 3: L. boz-dum-gor-jord-longb-mic Immunofluorescence assay for detection of IgG antibodies against Legionella pneumophila serogroup 1-14 and six non-pneumophila species of Legionella 10 x 30 I x 30 I

26 Molecular Diagnostics Molecular detection methods have revolutionized medical diagnosis and are an essential part of today s laboratory diagnostics. In many areas of infectious diseases the classical detection methods have been replaced or supplemented by polymerase chain reaction (PCR) assays. The earlier a disease is discovered and diagnosed, the better it can be treated. Molecular diagnostics allow for an early and specific diagnosis by direct detection of DNA or RNA of the pathogen thus leading to a selective and therapeutic treatment of the individual patient. R-Biopharm RIDA GENE kits are based on real-time PCR technology for detection of gastrointestinal infections, hospital acquired infections (HAI), respiratory infections and other infections. This highly sensitive and specific method provides rapid results. A variety of commercial manual or automated extraction systems can be used to obtain the DNA or RNA of the pathogen from different specimens. RIDA GENE kits can be run on commonly used real-time PCR instruments, such as the LightCycler, SmartCycler, CFX, ABI 7500/7500 FAST or Mx series. This allows a flexible use of the RIDA GENE kits for routine diagnostics. R-Biopharm RIDA GENE kits include all necessary components required for the specific detection of pathogens. An included internal control detects PCR inhibition, monitors reagent integrity and confirms that nucleic acid extraction was sufficient. All R-Biopharm RIDA GENE kits are CE marked and are regularly evaluated by participation in the QCMD (Quality Control for Molecular Diagnostics) quality assessment. Hospital Acquired Infections Gastrointestinal Infections Respiratory Infections Other Infections Real-time PCR instruments 1 RIDA GENE Color Compensation Kit I required 2 RIDA GENE Color Compensation Kit II required 3 RIDA GENE Color Compensation Kit IV required CD Toxin A/B Clostridium difficile HyperTox Clostridium difficile Hospital Stool Panel MRSA Clostridium difficile LC2.0 MRSA LC2.0 Viral Stool Panel I Viral Stool Panel II Bacterial Stool Panel EHEC/EPEC ETEC/EIEC STEC Roche LightCycler Norovirus EAEC Entamoeba histolytica Norovirus I & II Rotavirus/Adenovirus Duplex Parasitic Stool Panel LightCycler LightCycler Cepheid SmartCycler Applied Biosystems ABI 7500/7500 FAST Abbott m2000rt Stratagene MX3005P Qiagen Rotor-Gene Q Biorad CFX TM Norovirus I & II LC2.0 STEC LC2.0 Flu Bordetella Flu LC2.0 P. jirovecii PVL Advantages of the R-Biopharm RIDA GENE kits: High sensitivity and specificity Contains all necessary components Reliable due to extraction control Efficient Only one PCR profile for RNA or DNA assays Flexible compatible with various real-time PCR instruments Validated CE marked & QCMD quality assessment participation R-Biopharm AG Product Catalogue

27 Molecular Diagnostics Gastrointestinal infections RIDA GENE EHEC/EPEC EAEC ETEC/EIEC STEC STEC LC2.0 Bacterial Stool Panel Norovirus Norovirus I & II Norovirus I & II LC2.0 Rotavirus/Adenovirus Duplex Viral Stool Panel I Viral Stool Panel II Parasitic Stool Panel Entamoeba histolytica Real-time PCR Real-time multiplex PCR for the direct qualitative detection and differentiation of EHEC, STEC, EPEC and EIEC/Shigella spp. in human stool samples and cultures Real-time PCR for the direct qualitative detection of enteroaggregative E. coli (EAEC) in human stool samples and cultures Real-time multiplex PCR for the direct qualitative detection and differentiation of ETEC and EIEC/ Shigella spp. in human stool samples and cultures Real-time multiplex PCR for the direct qualitative detection and differentiation of Shiga-toxin genes (stx1 and stx2) of Shiga-toxin producing E. coli (STEC) in human stool samples and cultures Real-time multiplex PCR for the direct qualitative detection and differentiation of Shiga-toxin genes (stx1 and stx2) of Shiga-toxin producing E. coli (STEC) in human stool samples and cultures on the LightCycler 2.0 Real-time multiplex PCR for the direct qualitative detection and differentiation of Salmonella spp., Campylobacter spp. and Yersinia enterocolitica in human stool samples Real-time RT-PCR for the direct, qualitative detection of Norovirus (genogroup I and II) in human stool samples Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of Norovirus genogroup I and genogroup II in human stool samples Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of Norovirus genogroup I and genogroup II in human stool samples on the LightCycler 2.0 Real-time multiplex RT-PCR for the qualitative detection and differentiation of Rotavirus and Adenovirus in human stool samples Real-time multiplex RT-PCR for the qualitative detection and differentiation of Norovirus, Rotavirus, Adenovirus and Astrovirus in human stool samples Real-time multiplex RT-PCR for the qualitative detection and differentiation of Rotavirus, Adenovirus and Astrovirus in human stool samples Real-time multiplex PCR for the qualitative detection and differentiation of Giardia lamblia, Entamoeba histolytica, Cryptosporidium parvum and Dientamoeba fragilis in human stool samples Real-time PCR for the direct, qualitative detection of Entamoeba histolytica in human stool samples and liver abscess puncture 100 stool/ cultures 100 stool/ cultures 100 stool/ cultures 100 stool/ cultures 100 stool/ cultures PG2205 PG2215 PG2225 PG2255 PG stool PG stool PG stool PG stool PG stool PG stool PG stool PG stool PG stool/ liver abscess puncture PG

28 Molecular Diagnostics Hospital acquired infections RIDA GENE MRSA MRSA LC2.0 Hospital Stool Panel Clostridium difficile Clostridium difficile LC2.0 CD Toxin A/B Clostridium difficile HyperTox Real-time PCR Real-time multiplex PCR for the direct qualitative detection of MRSA from human swab specimens (nose, nose/throat, axilla/groin/perineum, wound) and cultures Real-time multiplex PCR for the direct qualitative detection of MRSA from human swab specimens (nose, nose/throat, axilla/groin/perineum, wound) and cultures on the LightCycler 2.0 Real-time multiplex PCR for the direct qualitative detection and differentiation of Norovirus (genogroup I and II), Rotavirus and Clostridium difficile toxin genes A (tcda) and B (tcdb) in human stool samples Real-time multiplex PCR for the direct qualitative detection of Clostridium difficile and Clostridium difficile toxin genes A (tcda) and B (tcdb) in human stool samples and from cultures Real-time multiplex PCR for the direct qualitative detection of Clostridium difficile and Clostridium difficile toxin A (tcda) and toxin B (tcdb) genes in human stool samples and from cultures on the LightCycler 2.0 Real-time PCR for the direct qualitative detection of Clostridium difficile toxin genes A (tcda) and B (tcdb) in human stool samples and from cultures Real-time multiplex PCR for the direct qualitative detection and differentiation of the hypervirulent Clostridium difficile ribotype 027 and the 078-likegroup in human stool samples and from cultures 100 swab specimens (nose, nose/ throat, axilla/groin/ perineum, wound)/ cultures 100 swab specimens (nose, nose/ throat, axilla/groin/ perineum, wound)/ cultures PG0605 PG stool PG stool/ cultures 100 stool/ cultures 100 stool/ cultures 50 stool/ cultures PG0835 PG0845 PG0825 PG0855 R-Biopharm AG Product Catalogue

29 Molecular Diagnostics Respiratory infections RIDA GENE Flu Flu LC2.0 Bordetella Pneumocystis jirovecii Real-time PCR Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of Influenza A, Influenza B and H1N1v in human nasal swabs and throat swabs Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of Influenza A and Influenza B in human nasal swabs and throat swabs on the LightCycler 2.0 Real-time multiplex PCR for the direct qualitative detection and differentiation of Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii from human nasopharyngeal swabs and aspirates Real-time PCR for the direct, qualitative or quantitative detection of Pneumocystis jirovecii in human bronchoalveolar lavage fluid samples 100 nasal swab/ throat swab 100 nasal swab/ throat swab 100 nasopharynageal swabs/ nasopharynageal aspirates 100 bronchoalveolar lavage fluid PG0505 PG0525 PG2505 PG1905 Other infections RIDA GENE Real-time PCR PVL Real-time PCR for the direct qualitative detection of the PVL-gene (Panton-Valentine leukocidine) from human swab specimens (nose, wound) and cultures 100 swab specimens (nose, wound)/ cultures PG0645 Nucleic Acid Extraction Accessories for RIDA GENE RIDA Xtract Spin-filter based extraction kit for the simultaneous isolation and purification of DNA and RNA Matrix: serum / plasma / cerebral fluid / cell culture supernatant / other cell free body fluids (e.g. urine) / swabs / tissue biopsies / stool 250 preparations see Description PGZ001 Color Compensation RIDA GENE Color Compensation Kit I RIDA GENE Color Compensation Kit II RIDA GENE Color Compensation Kit IV Accessories for RIDA GENE For generating a Color Compensation File for 3- and 4-plex RIDA GENE real-time PCR experiments on the LightCycler 480II For generating a Color Compensation File for RIDA GENE real-time PCR experiments on the LightCycler 1.5/2.0 For generating a Color Compensation File for 5-plex RIDA GENE real-time PCR experiments on the LightCycler 480II 3 PG PG PG

30 Tumor Diagnostics The transformation of normal to cancerous cells is accompanied by changes in metabolism. Malignant cells exhibit increased glucose consumption as well as increased glycolysis compared to normal cells. The observation that glycolysis is preferred also under aerobic conditions was already noticed and published in the 1920s by the German Nobel laureate Otto Warburg and is known as the Warburg effect. The Warburg effect is still a topic of intensive research. The involved scientists hope that they will be able to find new diagnostics and therapeutics to fight cancer. In general cancer patients do not die because of a primary tumor but because of the metabolic consequences of uncontrolled tumor growth and expansion (metastasis). It is of utmost importance to identify these aggressive tumors early and to treat them with specific therapies. Transketolase dependent reactions regulate the non-oxidative part of the pentosephosphate-pathway (PPP) in glucose metabolism. This pathway generates NADPH and pentose phosphates. The latter are important for nucleic acid metabolism. Recent publications show, that beside the ubiquitous transketolase (TKT) other transketolase-like proteins exist. In 19 Coy et al. reported that transketolase-like 1 (TKTL1) is a transketolase-like protein with a 38 amino acid deletion compared to TKT. Since 19 TKTL1 is a matter of active research and many studies appeared on the role of TKTL1 in tumor metabolism. Expression studies on transketolase-like 1 show that the protein is found in aggressive tumors of different entities. The detection of TKTL1 is furthermore correlated with poor patient prognosis and metastasis. Furthermore published functional data is available. It has been shown, that the inhibition of TKTL1 expression by RNA interference results in reduced growth of tumor cells, while overexpression of TKTL1 promotes cell proliferation. Latest publications suggest an important role of TKTL1 in the metabolism of tumor cells. TKTL1 can be detected by immunohistochemistry in patient biopsies with RIDA PentoCheck IHC. R-Biopharm AG Product Catalogue

31 Tumor Diagnostics Primary Antibodies RIDA PentoCheck RIDA PentoCheck IHC mab JFC12T10 (IgG2b) Primary antibody for immunhistochemistry monoclonal mouse antibody for the detection of human transketolase-like 1 protein (TKTL1) 200 µg Tissue Samples T001 RIDA PentoCheck IHC for breast cancer: System for evaluation of TKTL1 staining intensity in micro-array sections (AEC and hematoxylin) Score 0 Score 1 Score 2 Score 3 31

32 Gastroenterology R-Biopharms Gastroenterology product portfolio is dedicated to the advanced diagnosis of gut-related diseases. The ELISA tests are suited for single plate or medium-high-throughput analysis on automated readers. Here at a glance the markers and their diagnostic relevance: Calprotectin A highly specific marker for gastrointestinal inflammation, which can be used to differentiate between irritable bowel disease (IBD) and irritable bowel syndrome (IBS), and for treatment monitoring. Haemoglobin and Haemo-/Haptoglobin Complex Two efficient markers for colon cancer screening which are superior in sensitivity and specificity compared to the commonly used Guaiac based tests. Pancreatic Elastase and Pankrin Two markers for the detection of Pancreas insufficiency and pancreatitis. Accessories: Stool collection and preparation tubes RIDASCREEN Stuhlröhrchen tubes allow for easy, rapid and clean sampling of the matrix stool. α 1 -Antitrypsin and siga Two markers which indicate the integrity of the gut wall, and which are relevant in monitoring and diagnosing the Leaky-Gut- Syndrome. ELISAs for diagnostic focus on Colon Cancer Prevention RIDASCREEN Haemoglobin RIDASCREEN Haemo-/Haptoglobin Complex Pancreatic Diagnostics Pankreatic Elastase ELISA Pankrin ELISA Inflammatory Bowel Disease / Leaky-Gut-Syndrome RIDASCREEN Calprotectin RIDASCREEN α 1 -Antitrypsin RIDASCREEN siga R-Biopharm AG Product Catalogue

33 Gastroenterology ELISA RIDASCREEN Haemoglobin Haemo-/Haptoglobin Complex α 1 -Antitrypsin siga Calprotectin Pancreatic Elastase ELISA Pancreatic Elastase ELISA Pankrin ELISA Enzyme immunoassays Enzyme immunoassay for the detection of haemoglobin Enzyme immunoassay for the detection of haemoglobin/haptoglobin complex Enzyme immunoassay for the detection of α 1 -Antitrypsin Enzyme immunoassay for the detection of secretoric IgA Enzyme immunoassay for the detection of calprotectin Enzyme immunoassays Enzyme immunoassay for the detection of pancreatic elastase Enzyme immunoassay for the detection of pancreatic elastase; additional standard (SK15) Enzyme immunoassay for the detection of pancreatic elastase and other pancreatic enzymes stool G09030 stool G09031 stool G09034 stool G09035 stool G09036 stool G09038 stool G09040 serum G09039 Accessories Accessories for RIDASCREEN RIDASCREEN Stuhlröhrchen For collection and preparation of stool samples, only use with RIDASCREEN Haemoglobin G09030 RIDASCREEN Haemo-/Haptoglobin Complex G09031 only use with RIDASCREEN Calprotectin G09036 unfilled; to use after internal validation GZ3002 GZ3006 GZ3003 Stool Preparation Set For collection and preparation of stool samples, only use with Pancreatic Elastase ELISA G09038 and G GZ3008 Also see: Instruments / Software / Accessories 33

34 Instruments / Software / Accessories The majority of ELISA test kits, especially the kits for detection of infectious diseases, are validated for use with most current laboratory instruments. We provide detailed flyers containing all important data for daily laboratory work. Furthermore the application specialists of R-Biopharm will always be at your disposal, answering your questions and finding solutions to your individual problems. Concerning allergy diagnostics we offer tools corresponding perfectly to the use of the RIDA AllergyScreen panels: the RIDA X-Screen, the RIDA quadro-screen and the ScreenShaker. The shaker is optimized for the incubation of the RIDA AllergyScreen membranes. The measuring tools RIDA X-Screen and RIDA quadro-screen combined with the corresponding evaluation software make a fast and precise evaluation possible. RIDA SOFT A.M.Sys is an optimized software for our allergy diagnostics customers, who perform allergy in vitro diagnostics with our single allergen disc system (specific IgE/IgG and Total IgE) RIDASCREEN ELISA. For Molecular Diagnostics we offer the Mx3005P, a real-time PCR platform for the reliable and accurate detection of nucleic acids. All RIDA GENE kits are validated on Mx3005P and their PCR profiles are preinstalled on the system. R-Biopharm AG Product Catalogue

35 Instruments / Software / Accessories Instruments for RIDASCREEN ELISA GEMINI Fully automated 2-plate ELISA processor on request RIDA X-Screen RIDA quadro-screen ScreenShaker for RIDA AllergyScreen Panels Instrument for single measurement and evaluation of RIDA AllergyScreen Panels including software for documentation/archiving Instrument for measurement and semiautomatic evaluation/documentation of up to four RIDA AllergyScreen Panels in parallel ZG1101 ZG1104 ZG2501 Incubation box Mx3005P for RIDA GENE real-time PCR Real-time PCR instrument with notebook computer ZG0701 MX3005P1 Mx3005P Real-time PCR instrument with desktop computer MX3005P2 Software RIDA SOFT Win.net RIDA SOFT A.M.Sys Software for measurement, evaluation and documentation of RIDASCREEN ELISA tests Allergy Management System; software for management of the allergen database, the patient database and for measurement, evaluation and documentation of RIDASCREEN ELISA allergy diagnostics (total IgE, spec. IgE and IgG) Z99 Z9997 Accessories for sampling and preparation PE-Pipets One way pipets for stool dilutions 500 Z0001 Stool collectors Paper collection strips for easy and clean stool sampling 100 Z3002 Vitamin Detection RIDASCREEN Enzyme binding assays for vitamin detection Biotin Quantitative detection of biotin in serum H

36 The R-Biopharm Group R-Biopharm AG R-Biopharm Inc. R-Biopharm España S.A. R-Biopharm Rhône Ltd. R-Biopharm France R-Biopharm Italia Srl. R-Biopharm China R-Biopharm Latinoamérica R-Biopharm Brasil Ltda. R-Biopharm Australia subsidiaries R-Biopharm AG An der neuen Bergstraße Darmstadt, Germany Phone: +49 (0) Fax: +49 (0) R-Biopharm AG Product Catalogue