R-Biopharm Product Catalogue, Clinical Diagnostics 2012

2012

R-Biopharm AG

Product Catalogue Clinical Diagnostics

R-Biopharm – for reliable diagnostics.

2R-Biopharm AG – Product Catalogue 2012

3

IntroductionEditorial Page 4

Overview of R-Biopharm test systems Page 6

Allergy DiagnosticsIntroduction Page 8

Products Page 9

Infectious Diseases / Antigen DetectionIntroduction Page 14

Products Page 15-17

Infectious Diseases / Antibody DetectionIntroduction Page 18

Products Page 19-23

Molecular DiagnosticsIntroduction Page 24

Products Page 25-27

Tumor DiagnosticsIntroduction Page 28

Products Page 29

GastroenterologyIntroduction Page 30

Products Page 31

Instruments / Software / AccessoriesIntroduction Page 32

Products Page 33

Vitamin Detection Page 33

R-Biopharm Contacts Page 35

General Terms of Sale and Delivery of R-Biopharm AG Page 37


R-Biopharm AG

Comprehensive solutions from a single source – reliable, tried and tested

R-Biopharm is a leading developer of test solutions for Clinical Diagnostics and Food & Feed

Analysis. In both sectors, the R-Biopharm test kits offer high precision and accuracy, key

requirements where patient and consumer health is at risk.

R-Biopharm’s future projects will offer further exciting prospects in the fields of Clinical

Diagnostics and Food & Feed Analysis. The foremost challenge is to advance the

development of new and versatile fast tests. These will shorten the time it takes to obtain

results from a wide range of analytical procedures.

Awards

R-Biopharm has earned numerous awards for its business performance. In 2004 the company

achieved a double success, being nominated as a finalist for “Entrepreneur of the Year 2004,

2005 and 2006“ as well as it was placed in 2004 and 2005 in the “Technology Fast 50”,

a ranking of Germany’s 50 fastest-growing technology companies.

R-Biopharm worldwide

Today the German parent company R-Biopharm AG is represented by subsidiaries

in the UK, USA, Italy, France, Latin America, Brazil, China, Spain and Australia

as well as by a worldwide extensive network of more than 80 distributors.

In addition, Switzerland, Austria, and the Netherlands are represented by

local Country Managers.

5

employees

1988 Foundation by Röhm GmbH Darmstadt, Germany 6

1990 First products on the market Distribution by Riedel de Haën

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1991 Management Buy Out by Dr. Ralf M. Dreher 11

1992 Own distribution of Agri Diagnostics 14

1993 Start distribution Clinical Diagnostics 22

1996 ISO 9001 and DIN EN 46001 34

1998 Foundation R-Biopharm Inc. USA 50

1999 Merger with Innova Labordiagostik GmbH 70

2000 Worldwide exclusive distribution rights for the Enzymatic Testkits of Roche Diagnostics

91

2001 Acquisition of Rhône Diagnostics Technologies Ltd. 147

2002 Foundation of R-Biopharm Italia Srl 160

2003 Move to new facilities (Landwehrstraße, Darmstadt) 170

2005 Foundation of R-Biopharm China 205

2006 Foundation of R-Biopharm LA and R-Biopharm Brasil Ltda. 235

2007 Foundation of R-Biopharm Espana S.A. and R-Biopharm Australia 280

2009 Move to new facilities (An der neuen Bergstraße, Darmstadt) 300

2010 Aquisition of Trilogy Analytical Laboratory Inc. (USA) and RefLab (Denmark)

350

R-Biopharm – History and Milestones

R-Biopharm AG Headquarters Darmstadt


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 world-wide 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.

An overview of R-Biopharm test systems

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RIDA®FLUOR • Immunofluorescence assays for antibody detection

(IgG) in serum

• Test set consisting of microslides, controls and reagents

RIDA® PentoCheck® • Highly specific primary mouse antibody

for immunohistochemistry

• Directed against human transketolase-like 1

protein (TKTL1)

RIDA®BLOT and 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

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• Reliable rapid test for antigen detection

• High sensitivity and specificity

• Agents distinguished by color

• 2 test formats:

• dipstick

• cassette

RIDA®GENE • Real-time PCR

• Contains all necessary components

• High sensitivity and specificity

• Can be run on commonly used real-time PCR instruments


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.

Especially in 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.) in-vitro diagnostics are frequently the only

possibilities to confirm an atopic sensitization.

RIDASCREEN® ELISA – single and panel testing RIDASCREEN® ELISA is an enzyme immuno-assay 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 manage-ment and storage.

RIDASCREEN® spec. IgG Foodscreen The specific IgG Foodscreen is an enzyme immunoassay for the quantitative deter-mination 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, RIDA® quadro-Screen or RIDA® maXi-Screen 2.

Histamine-Release-Test (HR-Test) – single and panel testingThe HR-Test is an in-vitro method to detect allergen induced histamine release from basophil leukocytes by the use of a patented glassfiber 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 testing• Histamine-Release-Test – functional cellular allergy diagnostics

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Product Description Tests Matrix Art. No.

Allergy Diagnostics

RIDASCREEN® Enzym immunoassay for antibody detection

Allergenscheibe 1 allergen disc for an enzyme immunoassay for the determination of circulating allergen-specific IgE/IgG in serum • Quantitative determination of specific IgE/IgG• Positive and negative control• without reagents

1 Serum A0049

Spez. IgE Allergenscheibe 1 allergen disc for an enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • Quantitative determination of specific IgE• Positive and negative control• including reagents

1 Serum A0249

Spez. IgE Reagenziensatz Set of reagents for an enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • incl. standards and controls• sufficient for 0-96 determinations

96 Serum A0041

Spez. IgE Reagenziensatz Set of reagents for an enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • incl. standards and controls• sufficient for 0-192 determinations

192 Serum A0040

Spez. IgE Standard- und Kontrollsatz

Set of standards and controls for an enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • sufficient for 4 approaches in double

determination

4 A004006

Spez. IgG Allergenscheibe 1 allergen disc for an enzyme immunoassay for the determination of allergen-specific IgG in serum • quantitative determination of specific IgG• high and low control• including reagents

1 Serum A0629

Spez. IgG Reagenziensatz Set of reagents for an enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • incl. standards and controls• sufficient for 0-96 determinations

96 Serum A0021

Spez. IgG Reagenziensatz Set of reagents for an enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • incl. standards and controls• sufficient for 0-192 determinations

192 Serum A0020

Total IgE Enzyme immunoassay for the quantitative determination of circulating total-IgE in serum

96 Serum A0141

ELISA – Single Allergen Format



Allergy Diagnostics

RIDASCREEN® Enzym immunoassay for antibody detection

Spez. IgE Allergietest 1 Atopie

Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • 10 panels with 16 atopical allergens each• including reagents

10 Serum A0251

Spez. IgE Allergietest 2 inhalativ

Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • 10 panels with 16 respiratory allergens each• including reagents

10 Serum A0252

Spez. IgE Allergietest 3 Nahrungsmittel

Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • 10 panels with 16 food allergens each• including reagents

10 Serum A0253

Spez. IgE Allergietest 4 pädiatrisch

Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • 10 panels with 16 pediatric allergens each• including reagents

10 Serum A0254

Spez. IgE Allergietest modular

Enzyme immunoassay for the determination of circulating allergen-specific IgE in serum • 10 panels with 16 customized allergens each• including reagents

10 Serum A0250

Spez. IgG Allergietest modular*

Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • 10 panels with 16 customized allergens each• including reagents

10 Serum A0630

ELISA – Panel Format

* minimum order of customized panels is 10 kits

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ELISA – Foodscreen

Allergy Diagnostics

Enzym immunoassay for detection of spec. IgG against foodstuffs

spec. IgG Foodscreen, Customized Plate

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 sufficient for 1 or more patients

1 Serum A8101

spec. IgG Foodscreen, Plate 1


against 91 common food allergens• 1 plate is sufficient for 1 patient

5 Serum A8121


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 sufficient for 1 patient

5 Serum A8221


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 sufficient for 1 patient

5 Serum A8321



against 45 food allergens• 1 plate is sufficient for 2 patients

1 Serum A8621

spec. IgG Foodscreen, Prescreen 1

Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • Prescreen 1 • 1 plate is sufficient for 4 Patients• quantitative determination of specific IgG

against 23 common food allergens for screening purposes

1 Serum A8921

spec. IgG Foodscreen, Prescreen 2

Enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • Prescreen 2• 1 plate is sufficient for 4 Patients• quantitative determination of specific IgG

against 23 common food allergens for screening purposes

1 Serum A8929

spec. IgG Foodscreen, Reagents

Set of reagents for an enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • sufficient for 15 plates

15 Serum A8020

spec. IgG Foodscreen, Cut-off

Set of cut-off controls for an enzyme immunoassay for the determination of circulating allergen-specific IgG in serum • necessary for prescreen plates• sufficient for 15 plates

15 Serum A8926

CE certified ELISA against non IgE mediated food allergyNew!


Allergy Diagnostics


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

10 Serum A2142

AllergyScreen® Panel 2 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum • 20 respiratory allergens• Test membranes (nitrocellulose membrane)

in reaction troughs

10 Serum A2242

AllergyScreen® Panel 3 Immunoblot for semiquantitative determination of circulating allergen-specific IgE in serum • 20 food allergens• Test membranes (nitrocellulose membrane)

in reaction troughs

10 Serum A2342

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 Serum A2442

Solution for automatisation available, please ask the local distributor.

Accessories for RIDA® AllergyScreen and RIDASCREEN® Specific IgE, total IgE and Specific IgG see: Instruments / Software / Accessories

Immunoblots

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Allergy Diagnostics


Cellular Allergy Diagnostics

Functional allergy diagnostics by detecting the symptom causing agent: histamine

New!

Fluorometric detection of basophil histamine release

Plate format INHALATION PANEL

Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 respiratory

allergens in 6 diff. concentrations

10 Heparinized blood

RLA212-INH

Plate format FOOD PANEL Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 food allergens

in 6 diff. concentrations


RLA213-FOOD

Plate format DERMA PANEL Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 dermatological

related allergens in 6 diff. Concentrations


RLA214-DER

Plate format FOOD ASIA PANEL

Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 food allergens

in 6 diff. concentrations


RLA223-FOOD

Plate format INHALATION ASIA PANEL

Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 respiratory

allergens in 6 diff. concentrations


RLA222-INH

Plate format CUSTOMER DESIGNED*

Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with 10 customer

designed allergens


RLA800-CD

Plate format CUSTOMER MATERIAL

Fluorescence assay for allergen induced histamine release from human basophils • Microtiter plates coated with histamine and

anti-IgE• For the usage of own prepared allergens


RLA211-CM

Strip format VARIOUS ALLERGENS*

Fluorescence assay for allergen induced histamine release from human basophils • 8-well strips coated with 1 allergen*• 1 allergen per strip and 5 identical strips/kit

5 Heparinized blood

RLA-Xxxx**

Strip format VARIOUS ALLERGENS*

Immunofluorescence assay for allergen induced histamine release from human basophils • 8-well strips coated with up to 10 allergens*• 120 strips/kit and up to 10 different allergens a

12 strips/kit (Please remember to order min. 10 of Art. No. RLA500)


RLA120

Supplementary kits for HR-Test-Kit

HR-Test Reagent kit HISTAREADER™

• For detection of released histamine• Necessary only in combination with a

HISTAREADER™ 501-1

1 / RLA700

Preparation vial IL-3 coated preparation vial for activation of human basophil histamine release***

5 / RLA500

* Available allergens: please contact your local distributor for more information ** For detailed art. no. please contact your local distributor *** Min order = 10 kits


Infectious Diseases / Antigen Detection

The diagnostics of infectious intestinal dis-eases belongs to the most frequent require-ments 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 microbio-logy, immunological tests like ELISA and immunochromatographic rapid tests play an increasingly important role in the micro-biological lab. Their advantage over cultur-ing methods is the possibility of detecting also those germs that are no longer able to multiply.

Usually, an infection caused by enteropatho-genic 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 infec-

tious 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, Campylo-bacter 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 speci-mens.

The ELISA systems are available under the trade name RIDASCREEN®, the immuno-chromatographic rapid tests under the trade name RIDA®QUICK respectively. The rapid tests are offered as dipsticks as well as in the practical cassette format.

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.

Available parameters for the detection of:Bacteria

• Campylobacter• Clostridium difficile GDH (Glutamate dehydrogenase) • E. coli O157

Toxins

• Clostridium difficile Toxin A/B• Clostridium perfringens Enterotoxin• Verotoxins (Shigatoxins)

Parasites

• Cryptosporidium• Entamoeba• Giardia

Viruses

• Adenovirus• Astrovirus• Norovirus• Rotavirus

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RIDASCREEN® Enzym immunoassays for antigen detection

Adenovirus Enzyme immunoassay for the detection of Adenoviruses

96 stool C1001

Astrovirus Enzyme immunoassay for the detection of Astroviruses

96 stool C1301

Campylobacter Enzyme immunoassay for the detection of Campylobacter

96 stool C2401

Clostridium difficile Toxin A/B

Enzyme immunoassay for the detection of the toxins A and B of C. difficile

96 stool C0801

Clostridium difficile GDH Enzyme immunoassay for the detection of glutamate dehydrogenase of Clostridium difficile

96 stool C0701

Clostridium perfringens Enterotoxin

Enzyme immunoassay for detection of enterotoxin of C. perfringens

96 stool C0601

Cryptosporidium Enzyme immunoassay for the detection of Cryptosporidium parvum

96 stool C1201

Entamoeba Enzyme immunoassay for the detection of Entamoeba histolytica/dispar

96 stool C1701

Giardia Enzyme immunoassay for the detection of Giardia lamblia

96 stool C1101

Norovirus Enzyme immunoassay for the detection of Noroviruses

96 stool C1401 C1401US*

Rotavirus Enzyme immunoassay for the detection of Rotaviruses

96 stool C0901

Verotoxin Enzyme immunoassay for the detection of verotoxins 1 and 2 (Shigatoxins 1 and 2) of E. coli bacteria

96 stool mTSB-Bouillon

C2201

RIDA®

Enrichment broth mTSB-bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria

10025

Z1000 Z1003

* Only for sale in the US

ELISA


FDA cleared




RIDA®QUICK Rapid assays for antigen detection

Campylobacter Single pouched cassettes 25 stool N2403


Single pouched cassettes 25 stool N0803

Cryptosporidium Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium parvum

25 stool N1202

Cryptosporidium Single pouched cassettes 20 stool N1203

Cryptosporidium/ Giardia Combi

Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium parvum and/or Giardia lamblia

25 stool N1122

Cryptosporidium/ Giardia Combi


Cryptosporidium/ Giardia/Entamoeba Combi

Box with strips Immunochromatographic rapid assay for the detection of Cryptosporidium and/or Giardia and/or Entamoeba

25 stool N1722

Cryptosporidium/ Giardia/Entamoeba Combi


Entamoeba Box with strips Immunochromatographic rapid assay for the detection of Entamoeba histolytica/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 Single pouched cassettes Immunochromatographic Flow Through rapid assay for the detection of Noroviruses

20 stool N1403

Norovirus Single pouched cassettes Immunochromatographic Lateral Flow rapid assay for the detection of Noroviruses

25 stool N1402

Rotavirus Single pouched cassettes 20 stool N0903

Rotavirus/Adenovirus Combi

Box with strips Immunochromatographic rapid assay for the detection of Rotaviruses and/or Adenoviruses

25 stool N1002

Rotavirus/Adenovirus Combi


Verotoxin/0157 Combi

Box with strips Immunochromatographic rapid assay for the detection of verotoxins and/or E. coli O157

25 mTSB-Bouillon

N2202

Verotoxin/0157 Combi

Single pouched cassettes 20 mTSB-Bouillon

N2203

RIDA®

Enrichment broth mTSB-Bouillon with Mitomycin C for the enrichment of verotoxin (shigatoxin)-producing E. coli bacteria

25 Z1003

Rapid

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Controls for RIDA®QUICK Rapid assays

Campylobacter Positive control 1.8 ml NP2404


Positive control 1.8 ml NP0804

Norovirus Positive control 1.8 ml NP1404

Parasite Combi Control


Rotavirus/Adenovirus Combi Control


Verotoxin/O157 Combi Control


Accessories for RIDASCREEN® and RIDA® Antigen Detection tests see: Instruments / Software / Accessories


Product Description Volume Matrix Art. No.

Controls

RIDA®QUICK Sample diluent

Rotavirus/Adenovirus tubes with 1.5 ml sample diluent 25 stool ZN1004


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• Fungal infection: Candida albicans

Infectious Diseases / Antibody Detection

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.

For this reason we place a special focus on the selections of antigens used in our RIDASCREEN® ELISA for parasite diagnostics. Also in this product line all test share common buffers and incubation times.

RIDASCREEN® ELISA for parasite diagnostics:

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 mini-mum 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 the minimum. Interpretation of results is quick and easy by using RIDA®SOFT Win software.

In addition to the RIDASCREEN® Sero ELISA product line R-Biopharm offers two more groups for infectious serological diagnostics:

RIDASCREEN® Sero ELISA:

RIDASCREEN® ELISA for Chlamydia diagnostics:Identification of species-specific antibodies is the decisive factor in the diagnosis of Chlamydia. The high crossreactivity of most antigens poses an immense problem for this diagnostic test. Only certain components of the outer membrane protein complex allow the separate identification of antigens against C. trachomatis and

C. pneumoniae. By using these proteins in the RIDASCREEN® ELISA we offer two 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.

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.

All RIDASCREEN® Sero ELISA test kits contain two additional controls for

quality assurance purposes.

New!

19


Sero ELISA


RIDASCREEN® Enzyme immunoassays for antibody detection

Adenovirus lgA Adenovirus lgG

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

9696

Serum Serum

K1011 K1021

Bordetella lgA Bordetella lgG Bordetella lgM

Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Bordetella pertussis and parapertussis Differentiation between infections and immune status after vaccination

969696

Serum Serum Serum

K2511 K2521 K2531

Borrelia lgG Borrelia lgM

Enzyme immunoassays for specific detection of IgG or IgM antibodies against Borrelia burgdorferi sensu lato

9696

Serum Serum

K3221 K3231

Borrelia Liquor IgG Borrelia Liquor IgM

Set of reagents (without microplate) as supplement to test kits K3221 and K3231 For investigation of serum/CSF pairs

100100

CSF CSF

KLiq3221 KLiq3231

Candida lgA Candida lgG Candida lgM

Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Candida albicans and other antigenetically related Candida species

969696

Serum Serum Serum

K9011 K9021 K9031

Diphtherie lgG 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)

96 Serum K3821

EBV EBNA lgG 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

96 Serum K6621

EBV VCA lgG EBV VCA lgM

Enzyme immunoassays for specific detection of IgG or IgM antibodies against structure proteins (VCA = virus capsid antigen) of the Epstein-Barr- Virus (EBV)

9696

Serum Serum

K6721 K6731

Helicobacter lgA Helicobacter lgG

Enzyme immunoassays for specific detection of IgA or IgG antibodies against Helicobacter pylori

9696

Serum K2311 K2321

HSV 1 lgG (glycoprotein G1) HSV 1 lgM (total antigen) HSV 2 lgG (glycoprotein G2) HSV 2 lgM (total antigen)

Enzyme immunoassays for type-specific detection of IgG antibodies against the Herpes-Simplex- Viruses (HSV) by use of glycoprotein G (gG) Recombinant gG1 of HSV 1 and purified gG2 of HSV 2 Differentiation between a primary infection (IgG antibody negative) and a recurrence (IgG antibody positive)

96969696

Serum Serum Serum Serum

K5121 K5131 K5221 K5231

HSV 1+2 lgG (total antigen) HSV 1+2 lgM (total antigen)

Screening tests for specific detection of IgG or IgM antibodies against Herpes-Simplex-Viruses type 1 and type 2 (HSV 1, HSV 2)

9696

Serum Serum

K5021 K5031

Influenza A lgA Influenza A lgG Influenza B lgA Influenza B lgG

Enzyme immunoassays for specific detection of IgA or IgG antibodies against Influenza viruses of type A or B

96969696

Serum Serum Serum Serum

K6311 K6321 K6411 K6421

All RIDASCREEN® Sero ELISA test kits contain two additional controls for quality assurance purposes

New!




Sero ELISA

All RIDASCREEN® Sero ELISA test kits contain two additional controls for quality assurance purposes

New!

New!


Masern/Measles Virus lgG Masern/Measles Virus lgM

Enzyme immunoassays for specific detection of IgG or IgM antibodies against Measles virus IgG-analysis in international units (IU/ml)

9696

Serum Serum

K5421 K5431

Mumps Virus lgG Mumps Virus lgM

Enzyme immunoassays for specific detection of IgG or IgM antibodies against Mumps virus

9696

Serum Serum

K5521 K5531

Mycoplasma pneumoniae lgA Mycoplasma pneumoniae lgG Mycoplasma pneumoniae lgM

Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Mycoplasma pneumoniae

96

96

96

Serum Serum Serum

K4311 K4321 K4331

Parainfluenza 1, 2, 3 lgA Parainfluenza 1, 2, 3 lgG

Screening test for specific detection of IgA or IgG antibodies against Parainfluenza viruses of type 1, 2 and 3

9696

Serum Serum

K5811 K5821

Parvovirus B19 lgG Parvovirus B19 lgM

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)

9696

Serum Serum

K6021 K6031

RSV lgA RSV lgG RSV lgM

Enzyme immunoassays for specific detection of IgA, IgG or IgM antibodies against Respiratory Syncytial Virus (RSV)

969696

Serum Serum Serum

K5911 K5921 K5931

Tetanus lgG Enzyme immunoassay for specific detection of IgG antibodies against the tetanus toxoid Analysis in international units (IU/ml)

96 Serum K3721

VZV lgA VZV lgG VZV lgM

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 (IU/ml)

969696

Serum Serum Serum

K5611 K5621 K5631

21


Parasite Diagnostics



Echinococcus lgG Enzyme immunoassay for specific detection of IgG antibodies against Echinococcus granulosus and Echinococcus multilocularis

96 Serum K7621

Entamoeba histolytica IgG Enzyme immunoassay for specific detection of IgG antibodies against Entamoeba histolytica

96 Serum K1721

Leishmania Ab Enzyme immunoassay for specific detection of IgG antibodies against Leishmania

96 Serum K7121

Taenia solium lgG Enzyme immunoassay for specific detection of IgG antibodies against the larval forms of Taenia solium (cysticercosis)

96 Serum K7721

Toxocara lgG Enzyme immunoassay for specific detection of IgG antibodies against Toxocara canis

96 Serum K7421

Trichinella lgG Enzyme immunoassay for specific detection of IgG antibodies against Trichinella spiralis

96 Serum K7521

Please contact R-Biopharm AG for automatic solutions

Chlamydia Diagnostics


Chlamydia IgG/IgM Enzyme immunoassay for specific detection of IgG or IgM antibodies against LPS antigen (LPS = lipopolysaccharide) of Chlamydia

96 Serum KGM3101

Chlamydia trachomatis IgA Chlamydia trachomatis IgG/IgM

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

96 96

Serum Serum

K2911 KGM2901

Chlamydophila pneumoniae lgA Chlamydophila pneumoniae lgG Chlamydophila pneumoniae lgM

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

96

96

96

Serum Serum Serum

K2811 K2821 K2831

Please contact R-Biopharm AG for automatic solutions

Accessories

Accessories for RIDASCREEN® and RIDA® Antibody Detection tests

RF-Absorbens Anti-human IgG for absorption of rheumatoid factors (RF) and IgG antibodies in human serum or plasma

50 Serum Z0202

Accessories for RIDASCREEN® and RIDA® Antibody Detection tests see: Instruments / Software / Accessories



Western blots and Line blots for specific antibody detection


RIDA®BLOT and RIDA®LINE – Western blots and Line blots

Aviditätsreagenz for avidity testing in Line blots 25 Serum LB0023

Helicobacter lgA Helicobacter lgG

Line blots for specific detection of IgA or IgG antibodies against Helicobacter pylori Differentiation between Helicobacter pylori type I and II

2020

Serum Serum

LB2313 LB2323

Parvovirus B19 lgG Parvovirus B19 lgM

Line blots for specific detection of IgG or IgM antibodies against Parvovirus B19 with procaryotic and eucaryotic recombinant antigens 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

2020

Serum Serum

LB6023 LB6033

Parvovirus B19 lgG/lgM Western blot for specific detection of IgG or IgM antibodies against Parvovirus B19 with procaryotic recombinant antigens Western blots allow differentiation between acute and past infection with Parvovirus B19 Indicative for a probably persistent Parvovirus B19 infection

20 Serum L6003

New!

New!

23


RIDA®FLUOR Immunofluorescence assays

Legionella lgG (3 Pools)

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 Serum I8521

Slides for immunofluorescence assays

Legionella IgG Slides (3 Pools)

Row 1: SG 1 - 6 Row 2: SG 7 - 14 Row 3: L. boz-dum-gor-jord-longb-mic

10 x 30 Serum I8525

Immunofluorescence assays for antibody detection



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.

Advantages of the R-Biopharm RIDA®GENE kits:• High sensitivity• High specificity• Contains all necessary components• Reliable due to internal control• Flexible – can be run on commonly used real-time PCR instruments• Validated – CE marked & QCMD quality assessment participation

1 RIDA®GENE IAC Plus Accessory reagent is required for Norovirus, Norovirus LC, Norovirus I & II, Rotavirus/Adenovirus Duplex, EHEC/EPEC, ETEC/EIEC, STEC and EAEC.2 RIDA®GENE Color Compensation Kit I required 3 RIDA®GENE Color Compensation Kit II required

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 ofDNA or RNA of the pathogen thus leading to a selective and therapeutic treatment ofthe individual patient.R-Biopharm RIDA®GENE-kits are based on real-time PCR technology for detection of gastrointestinal infections, hospital acquired infections (HAI) and respiratory infections. This highly sensitive and specific method provides rapid results. A variety of commer-cial 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 LightCycler®, SmartCycler®, ABI series or Mx series. This allows for 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 potential PCR inhibition and ensures reliable results. 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.

Real-time PCR instrument

RIDA®GENEClostridium difficile & Toxin A/B LCCD Toxin A/B LCNorovirus LC

Clostridium difficile & Toxin A/B VCD Toxin A/B V Norovirus V

Clostridium difficile HyperTox

CD Toxin A/BEAECNorovirus

MRSAHospital Stool PanelEHEC/EPECETEC/EIECSTECBacterial Stool PanelFluNorovirus I & IIRotavirus/Adenovirus DuplexParasitic Stool Panel

MRSA LC2.0STEC LC2.0Flu LC2.0Norovirus I & II LC2.0

Roche LightCyler® 1.5

LightCyler® 2.0 3 3

LightCyler® 480 2

Cepheid SmartCycler ® 1 1 1

Applied Biosystems

ABI 7000

ABI 7300

ABI 7500

ABI 7700

ABI 7900 HT

StepOne

Abbott m2000rt

Stratagene Mx3000P

MX3005P

Qiagen Rotor-Gene Q

25

RIDA®GENE Real-time PCR

EHEC/EPEC Real-time multiplex PCR for the direct qualitative detection and differentiation of EHEC, STEC, EPEC and EIEC/Shigella spp. in human stool samples and culture

100 stool/culture

PG2205

EAEC Real-time PCR for the direct qualitative detection of enteroaggregative E. coli (EAEC) in human stool samples and culture

100 stool/culture

PG2215

ETEC/EIEC Real-time multiplex PCR for the direct qualitative detection and differentiation of ETEC and EIEC/Shigella spp. in human stool samples and culture

100 stool/culture

PG2225

STEC 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 culture

100 stool/culture

PG2255

STEC LC2.0 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) on the LightCycler® 2.0 in human stool samples and culture

100 stool/culture

PG2275

Bacterial Stool Panel Real-time multiplex PCR for the direct qualitative detection and differentiation of Salmonella spp., Campylobacter spp. and Yersinia enterocolitica in human stool samples

100 stool PG2405

Norovirus V Real-time RT-PCR for the direct, qualitative detection of norovirus (genogroup I and II) in human stool samples

100 stool PG1405V

Norovirus LC Real-time RT-PCR for the direct, qualitative detection of norovirus (genogroup I and II) in human stool samples

100 stool PG1405LC

Norovirus* Real-time RT-PCR for the direct, qualitative detection of norovirus (genogroup I and II) in human stool samples

100 stool PG1405

Norovirus I & II Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of norovirus genogroup I and genogroup II in human stool samples

100 stool PG1415

Norovirus I & II LC 2.0 Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of norovirus genogroup I and genogroup II on the LightCycler® 2.0 in human stool samples

100 stool PG1425

Rotavirus/Adenovirus Duplex

Real-time RT-PCR for the qualitative detection and differentiation of rotavirus and adenovirus in human stool samples

100 stool PG0905

Parasitic Stool Panel Real-time multiplex PCR for the qualitative detection and differentiation of Giardia lamblia, Entamoeba histolytica, Cryptosporidium parvum and Dientamoeba fragilis in human stool samples

100 stool PG1705



Gastrointestinal Infections

* soon available



MRSA Real-time multiplex PCR for the direct qualitative detection of MRSA in human nasal swabs and culture

100 nasal swab/culture

PG0605

MRSA LC2.0 Real-time multiplex PCR for the direct qualitative detection of MRSA on the LightCycler® 2.0 in human nasal swabs and culture

100 nasal swab/culture

PG0625

Hospital Stool Panel Real-time multiplex PCR for the direct qualitative detection and differentiation of rotavirus, norovirus and Clostridium difficile in human stool samples

100 stool PG0705

Clostridium difficile & Toxin A/B V

Real-time PCR for the qualitative detection of Clostridium difficile and Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes in human stool samples

2 x 100 stool PG0805V

Clostridium difficile & Toxin A/B LC

Real-time PCR for the qualitative detection of Clostridium difficile and Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes in human stool samples

2 x 100 stool PG0805LC

CD Toxin A/B V Real-time PCR for the qualitative detection of Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes in human stool samples

100 stool PG0825V

CD Toxin A/B LC Real-time PCR for the qualitative detection of Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes in human stool samples

100 stool PG0825LC

CD Toxin A/B Real-time PCR for the qualitative detection of Clostridium difficile toxin A (tcdA) and toxin B (tcdB) genes in human stool samples

100 stool PG0825

Clostridium difficile HyperTox

Real-time multiplex PCR for the direct qualitative detection and differentiation of the hypervirulent Clostridium difficile ribotype 027 and the 078-like-group in human stool samples

50 stool PG0855



Hospital Acquired Infections

27


Flu 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

100 nasal swab/ throat swab

PG0505

Flu LC2.0 Real-time multiplex RT-PCR for the direct qualitative detection and differentiation of Influenza A and Influenza B on the LightCycler® 2.0 in human nasal swabs and throat swabs

100 nasal swab/ throat swab

PG0525



Respiratory Infections


In general cancer patients do not die because of a primary tumor but because of the metabolic consequences of uncon-trolled 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 pentose-phos-phate-pathway (PPP) in glucose metabo-lism. This pathway generates NADPH and pentose phosphates. The latter are impor-tant for nucleic acid metabolism. Recent publications show, that beside the ubiqui-tous transketolase (TKT) other transketolase-like proteins exist. In 1996 Coy et al. reported that transketolase-like 1 (TKTL1) is a transketolase-like protein with a 38 amino acid deletion compared to TKT.

Since 1996 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 publica-tions 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.

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.

29


RIDA® PentoCheck® Primary Antibodies for immunohistochemistry

RIDA®PentoCheck® IHC mAb JFC12T10 (IgG2b)

monoclonal mouse antibody for the detection of human transketolase-like 1 protein (TKTL1)

200 Tissue Samples

T001

Primary Antibodies

Tumor Diagnostics

Score 0 Score 1 Score 2 Score 3

RIDA® PentoCheck® IHC for breast cancer:System for evaluation of TKTL1 staining intensity in micro-array sections (AEC and hematoxylin)

Analysis

Analysis can be performed using a light optical microscope or in an automated manner (e.g. Clariant Chromavision ACIS 11; automated digitalimage analysis system). Analysis may only be performed by sufficiently trained personnel under the supervision of an experienced pathologist.

The following (qualitative) scoring system is recommended for the non-automated analysis of micro-array samples(using the example of a series of micro-array samples from breast cancer patients)

RIDA® PentoCheck® IHC (T001)

The following (semi-quantitative) scoring system is recommended as a guideline for the non-automated analysis of tissue sections

– Score 0: 0 - 20 % of the tumor cells show TKTL1 staining– Score 1: 21 - 50 % of the tumor cells show TKTL1 staining– Score 2: 51 - 80 % of the tumor cells show TKTL1 staining– Score 3: > 80 % of the tumor cells show TKTL1 staining


Pento Check IHC (T001)_FINAL.qxp 22.11.2006 12:19 Seite 2

Analysis








Analysis








Analysis









RIDASCREEN® ELISA tests for specific detection of• Human haemoglobin and haemo-/haptoglobin complex in colorectal cancer screening (RIDASCREEN® Haemoglobin and RIDASCREEN® Haemo-/Haptoglobin Complex)• Changes of permeability in the gastrointestinal mucous membrane in various diseases (RIDASCREEN® a1-Antitrypsin)• Insight into the functional status of the gut associated lymphoid tissue (GALT) (RIDASCREEN® sIgA)• Reliable differentiation between IBD and IBS (RIDASCREEN® Calprotectin)

Gastroenterology

The analysis of stool matrix by using modern stool markers provides

numerous information on the gastrointestinal situation of a patient.

Until now these possibilities have either not been fully exploited or

not been adequately used in routine diagnostics. The significance of

the intestine, known to be the organ with the largest physiologically

effective surface area, is still completely underestimated with regards

to its importance for health in general.

In Germany, approximately 73.000 people are diagnosed each year as having bowel cancer. Colonoscopy is still the method of reference used for detecting carcinomas and adenomas. The detection of occult blood in stool samples is a frequently used screening method of detecting bowel cancer in its early stages. The commonly used guaiac tests are based on the pseudo-peroxidase activity of haemoglobin. These tests are highly sensitive to different food compounds and have therefore a limited significance for detecting bowel cancer.

Immunological test systems in contrast have a definite advantage by using specific antibodies exclusively directed against human haemoglobin respectively haemoglobin/haptoglobin complex: These tests can recognize human haemoglobin that is one hundred times lower in concentration compared to that in biochemical methods. False positive or false negative results due to interfering food compounds are nearly impossible.

More than 300.000 patients are suffering from inflammatory bowel disease (IBD) in Germany. In many cases, chronic inflamma-tory bowel disease shows symptoms that are very difficult to distinguish from those of irritable bowel syndrome (IBS). The recently developed new Calprotectin assay provided by R-Biopharm AG will further improve diag-nosis of CED.

Fecal calprotectin measurement provides a reliable differentiation between chronic inflammatory bowel disease and irritable bowel syndrome. In addition to this measurement of fecal calprotectin provides a means of objectively assessing the response to treatment of chronic inflammatory bowel disease and for monitoring these patients during clinical remission to enable the early detection and treatment of relapses of IBD.

With RIDASCREEN® ELISA tests R-Biopharm offers a range of excellent products for comprehensive and improved diagnostics in the field of gastroenterology.

31

RIDASCREEN® Enzyme immunoassays

Haemoglobin Enzyme immunoassay for the detection of haemoglobin

96 stool G09030

Haemo-/Haptoglobin Complex

Enzyme immunoassay for the detection of haemoglobin/haptoglobin complex

96 stool G09031

a1-Antitrypsin Enzyme immunoassay for the detection of a1-Antitrypsin

96 stool G09034

sIgA Enzyme immunoassay for the detection of secretoric IgA

96 stool G09035

Calprotectin Enzyme immunoassay for the detection of calprotectin

96 stool G09036

Accessories

Accessories for RIDASCREEN®

RIDASCREEN® Stuhlröhrchen

For collection and preparation of stool samples, • only use with

RIDASCREEN® Haemo-/Haptoglobin Complex G09031

• only use with RIDASCREEN® Calprotectin G09036

• unfilled for individual use for internal validationRIDASCREEN® Haemoglobin G09030

48

48

48

GZ3002

GZ3006* GZ3003

also see: Instruments / Software / Accessories

* available in many European countries. Please contact R-Biopharm for more information.

ELISA


Gastroenterology

New!


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.

Instruments / Software / Accessories

Concerning allergy diagnostics we offer tools corresponding perfectly to the use of the RIDA® AllergyScreen panels: the RIDA® X-Screen, the RIDA® quadro-Screen, the RIDA® maXi-Screen 2 and the ScreenShaker. The shaker is optimized for the incubation of the RIDA® AllergyScreen membranes.

The measuring tools RIDA® X-Screen, RIDA® quadro-Screen and RIDA® maXi-Screen 2 combined with the corresponding evaluation software make a fast and precise evaluation possible.

33

Accessories

PE-Pipets One way pipets for stool dilutions 500 Z0001

Stool collectors Paper collection strips for easy and clean stool sampling

100 Z3002

Instruments / Software

Instruments

Gemini Fully automated 2-plate ELISA processor on request

RIDA® X-Screen Instrument for single measurement and evaluation of RIDA® AllergyScreen Panels including software for documentation/archiving

ZG1101

RIDA® quadro-Screen Instrument for measurement and semiautomatic evaluation/documentation of up to 4 RIDA® AllergyScreen Panels in parallel

ZG1104

RIDA® maXi-Screen 2 Instrument for measurement and semiautomatic evaluation/documentation of up to 36 RIDA® AllergyScreen Panels in parallel

ZG1105

ScreenShaker ZG2501

Incubation Box ZG0701

Vitamin Detection

RIDASCREEN® Enzyme binding assays for vitamin detection

Biotin Quantitative detection of biotin in serum 96 Serum H1601

Accessories


Instruments / Software / Accessories

Software

RIDA®SOFT Win Software for measurement, evaluation and documentation of RIDASCREEN® ELISA tests

Z9999

RIDA®SOFT A.M.Sys Allergy Management System; software for management of the allergen data-base, the patient database and for measurement, evaluation and documentation of RIDASCREEN® ELISA allergy diagnostics (total IgE, spec. IgE and IgG)

Z9997


R-Biopharm AGAn der neuen Bergstraße 1764297 Darmstadt, GermanyPhone: +49 (0) 61 51 - 81 02-0Fax: +49 (0) 61 51 - 81 02-40

E-mail: [email protected]@r-biopharm.de

The R-Biopharm Group

www.r-biopharm.com

subsidiaries

distributors

R-Biopharm AG

R-Biopharm Australia

R-Biopharm China

R-Biopharm Latinoamérica

R-Biopharm Inc. R-Biopharm France

R-Biopharm España S.A.

R-Biopharm Rhône Ltd.

R-Biopharm Italia Srl.

R-Biopharm Brasil Ltda.

35

Contact Details

Division Management Clinical Diagnostics

Dr. Wolfgang Schartl Division Management Clinical Diagnostics Phone: +49 (0) 61 51 - 81 02-30 E-mail: [email protected]

Product Management Fax: +49 (0) 61 51 - 81 02-40

Allergy DiagnosticsJoachim Zehender Product Manager Allergy Diagnostics Phone: +49 (0) 61 51 - 81 02-45 E-mail: [email protected]

Hannah GörenProduct Specialist Allergy DiagnosticsPhone: +49 (0) 61 51 - 81 02-429E-Mail: [email protected]

Infectious Diseases (Antigen Detection)Helmut Leidinger Product Manager Stool Diagnostics Phone: +49 (0) 61 51 - 81 02-26 E-mail: [email protected]

Infectious Diseases (Antibody Detection)Dr. Johanna Endt Product Manager Serological Diagnostics Phone: +49 (0) 61 51 - 81 02-774 E-mail: [email protected]

GastroenterologyDr. Andrea Lennerz Product Manager Gastroenterology Phone: +49 (0) 61 51 - 81 02-632 E-mail: [email protected]

Stephanie WeilProduct Specialist GastroenterologyPhone: +49 (0) 61 51 - 81 02-736E-Mail: [email protected]

Project Manager Infectious Diseases Molecular DiagnosticsDr. Andreas Simons Project Manager Infectious Diseases Product Manager Molecular Diagnostics Phone: +49 (0) 61 51 - 81 02-96 E-mail: [email protected]

Janina DrynskiProduct Specialist Molecular DiagnosticsPhone: +49 (0) 61 51 - 81 02-410E-Mail: [email protected]

Secretary

Petra Schorr Phone: +49 (0) 61 51 - 81 02-23 E-mail: [email protected]

Clinical Sales International

Fax: +49 (0) 61 51 - 81 02-688

Director Clinical Sales International Jens-Uwe Wünsch Phone: +49 (0) 61 51 - 81 02-995 E-mail: [email protected]

International Sales Manager Asia / MENADr. Dieter GernetPhone: +49 (0) 61 51 - 81 02-28E-mail: [email protected]

International Sales Manager Europe / AfricaDr. Otto MannherzPhone: +49 (0) 61 51 - 81 02-446E-mail: [email protected]

International Sales Manager CIS Mongolia, CaucasusAnatolii BukPhone: +49 (0) 61 51 - 81 02-19E-mail: [email protected]

Support Sales International Martina Scheidenberger Phone: +49 (0) 61 51 - 81 02-52 E-mail: [email protected]

Support Sales InternationalCarsten MüllerPhone: +49 (0) 61 51 - 81 02-440E-Mail: [email protected]

Support Sales InternationalAndrea BeckerPhone: +49 (0) 61 51 - 81 02-531E-Mail: [email protected]

Order Department General contact Phone: +49 (0) 61 51 - 81 02-0Fax: +49 (0) 61 51 - 81 02-20 E-mail: [email protected]

AfricaJutta Wien Phone: +49 (0) 61 51 - 81 02-14

Asia, SwitzerlandIngrid Illich Phone: +49 (0) 61 51 - 81 02-61

Europe Monika Fröhlich Phone: +49 (0) 61 51 - 81 02-764

Eastern EuropePetra Vlasak Phone: +49 (0) 61 51 - 81 02-82

North, Middle- and South-America, OceaniaChristoph Polzin Phone: +49 (0) 61 51 - 81 02-54


37

I. General Provisions These General Terms & Conditions only are valid for entrepreneurs, legal

entities under public law or public-law special assets (legal entities according to § 310 I German Civil Code (“Bürgerliches Gesetzbuch” -”BGB”). We deliver according to these General Terms & Conditions exclusively. They are deemed to have been acknowledged with the placing of an order or the receipt of the goods and shall also apply to all future business relationships, even if they are not explicitly agreed upon again. Deviating Terms and Conditions are not binding for us, even if we do not object to them explicitly.

II. Orders and Offer Documents Our offers are subject to alteration. Decisive for the scope of our delivery

obligation are our offer in writing respectively our written order confirmation. Deliverable are only the products which are contained in our current applicable price lists.

III. Prices and Conditions of Payment / Withdrawal in case of default1. Purchase price is the price stated by us or - if no price has been stated - the price

which is contained in our price list, which is in effect on the day of the order. The prices stated by us - unless otherwise stipulated in writing - are including packing and shipping costs, excluding VAT. The deduction of cash discounts shall not be granted. A small-quantity surcharge in the amount of 10 Euros can be charged for deliveries with a product value of up to 300 Euros (small quantity).

2. Payment obligations resulting from the delivery of goods are to be fulfilled within thirty (30) days of the invoice date by bank transfer exclusively and shall be deemed to have been effected only to the extent, to which we can dispose of them freely at a bank. For checks and bills of exchange, a processing fee of 30 Euros shall be charged; discounting and expenses shall be for the account of the Buyer.

3. The Buyer shall only be entitled to set-off with a counter-claim which is undisputed or has been determined by a final verdict. A right of retention the Buyer does only have as far as it is resulting from the same contractual relationship.

4. Should the Buyer be in default with due payments entirely or partly, the regulations of the statutory law are applicable. Interest in the amount of 8% above the basic interest rate (as it is published by the German Federal Bank) shall be due. We are reserving the right to claim any exceeding damage for delay.

5. In case of withdrawal, we are entitled - at the expense of the Buyer - to let the goods, which have been delivered by us, mark, store separately and collect. The Buyer - already yet - is declaring his consent that the persons who are commissioned with the collection are entitled to access the premises, on which the goods are, and enter them by car for this purpose.

6. In case of our withdrawal, we are not obliged to further deliveries any more, also regarding further future deliveries.

IV. Retention of Title1. We shall retain title to the goods delivered by us, until all the claims, to

which we are entitled on whatever legal grounds arising from our business relationship with the Buyer, have been fully satisfied. Upon the Buyer’s request, we shall be obligated to release the securities in so far as their realizable value exceeds our claims by more than 10%. We reserve the right to select the items of collateral to be released.

2. The Buyer undertakes to only sell the goods, which are subject to retention, in his ordinary course of business, according to his usual terms and conditions of business and only as long as he is not in default with his payments. He is entitled to resell the goods, which are subject to retention, only on the condition that a transfer of the receivables, resulting from such a resale, to us takes place. He is not be entitled to dispose of the goods, which are subject to retention, in any another way (such as e. g. collateral assignment, pledging, leasing, lending, etc.). The Buyer is obligated to immediately notify us of any seizure or other interference by a third party, together with handing over of the documents which are necessary for an intervention.

V. Delivery1. Our delivery times are generally only approximate and not binding. 2. Uncontrollable incidents, for which we are not responsible, e. g. natural

phenomena, war, orders of the authorities, embargo, unexpected delays in the delivery of essential components and other materials (“Force Majeure”), shall prolong the delivery time reasonably. This also applies, if these incidents occur during a delay in delivery or at a sub-supplier. However, the delivery time shall be prolonged by a maximum period of two (2) months. Should we also not be able to deliver after this time, then the Buyer as well as we themselves are entitled to withdraw from the contract. Any claims of damages of the Buyer for this reason are excluded. Should we withdraw from the contract, we shall immediately refund the Buyer any and all payments possibly rendered for not yet delivered goods.

3. Should the Buyer - despite reminder - not fulfill his payment obligations resulting from existing contracts, we shall only supply on advance payment from then on.

4. We are entitled to partial deliveries to a reasonable extent; here each partial delivery can be invoiced separately. In case of order on call, the call-off has to take place at least two (2) calendar weeks prior to the desired delivery date.

VI. Shipment and Passing of Risk1. Dispatch ex works or distribution warehouse shall be carried out at the expense

of the Buyer. Shipping route and mode of dispatch shall be determined by

us. We shall only be obligated to obtain a transport insurance, if explicitly instructed to do so by the Buyer in writing; the Buyer shall bear the costs for this insurance.

2. The passing of risk to the Buyer takes place as soon as the goods have been handed over to the haulage contractor respectively leave our factory or distribution warehouse for the purpose of dispatch; this also is valid, if we - by way of exception - organize additional services, e. g. carriage prepaid shipping, delivery to the premises of the Buyer, or similar. In particular we are not liable for alteration or deterioration of the goods during transport or resulting from improper storage. Should we have notified the Buyer that the goods are ready for dispatch or collection, the risk passes on to the Buyer, if he does not have the goods delivered or collect them, despite of us having set him a reasonable period of time for doing so; regarding that, the passing of risk takes place at the beginning of the day which follows the day, on which the deadline has expired.

VII. Warranty / Liability1. It is precondition for the execution of claims based on a defect, that the Buyer

has performed his responsibilities to examine and complain according to § 377 of the German Commercial Code (“Handelsgesetzbuch” -”HGB”) correctly and completely.

2. We are liable for faultlessness of the goods corresponding to the state of the art. Features of samples and specimens as well as any statements regarding the condition of the goods, shall only be considered as an agreement on quality, if they explicitly have been agreed upon as determining the condition of the goods. Otherwise they are non-binding and do not free the Buyer from an own inspection of the goods concerning their suitability for his purposes. We neither grant guarantees with the content of a liability without fault nor any other kind of guarantees for quality and durability in the legal sense.

3. We are not liable for damages as far as they have been caused by improper storage of our products and/or their application contrary to the prescriptions - e. g. application after expiry of their shelf life or contrary to the direction for use - or as far as they have been caused by the Buyer in any other way.

4. The exceeding of use-by dates after the delivery does not entitle the Buyer to claims of any kind, but is deemed to be the usual condition. This is not the case, if the period between the date of delivery and the use-by date is less than four (4) calendar weeks.

5. We shall only be liable for damages, as far as we attributable have caused them by intent or gross negligence (disregard for the due care and attention to a very coarse extent); except in case of violation of essential contractual obligations (obligations, whose fulfillment enables the proper execution of the contract at all and on whose observance the contractual partner may rely regularly). In this last-mentioned case we are liable for each negligence with the restriction that - in case of violation of essential contractual duties by slight negligence - our liability is limited to the damage which typically is predictable.

6. Should we not have violated any essential contractual obligations in the sense mentioned before, we are not liable in cases of slight negligence. Unaffected by any limitation of liability contained in these General Terms & Conditions stay: Liability for intent, malice, initial inability, gross negligence, liability resulting from a guarantee (which, however, we generally not grant), bodily harms and other cases of legally compelling liability - in these cases the statutory law is valid (under exclusion of the Terms and Conditions of our contractual partner).

7. The regulations of this clause Warranty/Liability are valid for our contractual liability as well as liability resulting from tort (unaffected thereby stays the action for possession in case of tort, after statutory limitation has taken place, § 852 German Civil Code (“Bürgerliches Gesetzbuch” -BGB”)).

8. As far as our lability is excluded or limited, this shall also apply to the personal liability of our representatives, employees and vicarious agents and our liability for them.

9. As far as there is a defect of the goods, for which we are liable, the Buyer has to grant us the opportunity to execute subsequent performance within a term of generally two (2) calendar weeks, before the assertion of his further rights. In case that subsequent performance fails twice, in case of our refusal, or if subsequent performance is impossible, is delayed unreasonably or unreasonable for the Buyer due to other reasons, the Buyer may - according to his choice - execute his further legal rights, namely rescission or reduction of the purchase price and (regarding defects for which we are liable) claim of possibly occurred damages or compensation for possible futile expenditure, by which our liability is limited according to the preceding regulations.

VIII. Burden of Proof / Export / Effectiveness 1. With none of the stipulations of these General Terms & Conditions an alteration

of the burden of proof is intended.2. We are not liable for the correctness of information regarding foreign-trade

which we provide to our best conscience; it is the Buyer´s responsibility to assess the compliance with foreign-trade regulations with regard to our products himself.

3. Should any of the regulations of our General Terms & Conditions be ineffective and/or incomplete, the validity of the other regulations shall remain unaffected thereby.

IX. Applicable Law and Place of Jurisdiction1. The contractual relationship shall be governed by the laws of the Federal

Republic of Germany, which shall be applicable supplementary. The UN-convention on contracts regarding the International Sale of Goods (CISG) shall not apply.

2. Exclusive Place of Jurisdiction is Darmstadt (Germany). However, we are entitled to file a lawsuit against the Buyer also at any other court, which does have jurisdiction regarding him according to the general regulations.

General Terms & Conditions of R-Biopharm AG (Date of Issue: October 2010)


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R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, GermanyPhone: +49 (0) 61 51 - 81 02-0, Fax: +49 (0) 61 51 - 81 02-20 E-mail: [email protected] www.r-biopharm.com