R-Biopharm Product Catalogue, Clinical Diagnostics 2012

Transcription

R-Biopharm AG
Product Catalogue
Clinical Diagnostics
2012
R-Biopharm – for reliable diagnostics.
R-Biopharm AG – Product Catalogue 2012
2
Introduction
Editorial
Page
4
Overview of R-Biopharm test systems
Page
6
Introduction
Page
8
Products
Page
9
Introduction
Page
14
Products
Page
15-17
Introduction
Page
18
Products
Page
19-23
Introduction
Page
24
Products
Page 25-27
Allergy Diagnostics
Infectious Diseases / Antigen Detection
Infectious Diseases / Antibody Detection
Molecular Diagnostics
Tumor Diagnostics
Introduction
Page
28
Products
Page
29
Introduction
Page
30
Products
Page
31
Introduction
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
Gastroenterology
Instruments / Software / Accessories
3
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.
4
R-Biopharm – History and Milestones
employees
1988
Foundation by Röhm GmbH Darmstadt, Germany
6
1990
First products on the market
Distribution by Riedel de Haën
9
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 AG
Headquarters
Darmstadt
5
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 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.
6
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®FLUOR
• Immunofluorescence assays for antibody detection
(IgG) in serum
• Test set consisting of microslides, controls and reagents
RIDA® PentoCheck®
•
Highly specific primary mouse antibody
•
Directed against human transketolase-like 1
for immunohistochemistry
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
RIDA®GENE
• Real-time PCR
• Contains all necessary components
• High sensitivity and specificity
• Can be run on commonly used real-time PCR instruments
7
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 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.
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 testing
The 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.
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.
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
8
Allergy Diagnostics
ELISA – Single Allergen Format
Product
Description
RIDASCREEN®
Enzym immunoassay for antibody detection
Tests
Matrix
Art. No.
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
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
IgE in serum
• incl. standards and controls
• sufficient for 0-96 determinations
96
Serum
A0041
Spez. IgE Reagenziensatz
IgE in serum
192
Serum
A0040
Spez. IgE Standard- und
Kontrollsatz
Set of standards and controls for an enzyme
4
immunoassay for the determination of circulating
allergen-specific IgE in serum
• sufficient for 4 approaches in double
determination
Spez. IgG Allergenscheibe
the determination of allergen-specific IgG in
serum
• quantitative determination of specific IgG
• high and low control
1
Serum
A0629
Spez. IgG Reagenziensatz
IgG in serum
96
Serum
A0021
Spez. IgG Reagenziensatz
IgG in serum
192
Serum
A0020
Total IgE
Enzyme immunoassay for the quantitative
determination of circulating total-IgE in serum
96
Serum
A0141
9
A004006
Allergy Diagnostics
ELISA – Panel Format
Product
Description
RIDASCREEN®
Enzym immunoassay for antibody detection
Tests
Matrix
Art. No.
Spez. IgE Allergietest 1
Atopie
Enzyme immunoassay for the determination of
circulating allergen-specific IgE in serum
• 10 panels with 16 atopical allergens each
10
Serum
A0251
inhalativ
• 10 panels with 16 respiratory allergens each
10
Serum
A0252
Nahrungsmittel
• 10 panels with 16 food allergens each
10
Serum
A0253
pädiatrisch
• 10 panels with 16 pediatric allergens each
10
Serum
A0254
Spez. IgE Allergietest
modular
• 10 panels with 16 customized allergens each
10
Serum
A0250
Spez. IgG Allergietest
modular*
circulating allergen-specific IgG in serum
• 10 panels with 16 customized allergens each
10
Serum
A0630
* minimum order of customized panels is 10 kits
10
Allergy Diagnostics
ELISA – Foodscreen
Product
CE certified ELISA against non IgE
mediated food allergy
New!
Description
Tests
Matrix
Art. No.
Enzym immunoassay for detection of spec. IgG against foodstuffs
spec. IgG Foodscreen,
Customized Plate
against food allergens
• up to 91 allergens per plate
• 1 plate is sufficient for 1 or more patients
1
Serum
A8101
Plate 1
against 91 common food allergens
• 1 plate is sufficient for 1 patient
5
Serum
A8121
Plate 2
circulating allergen-specific IgG in serum.
against 90 common alternative food allergens
5
Serum
A8221
Plate 3
circulating allergen-specific IgG
against 91 rare food allergens and spices
5
Serum
A8321
Plate 6
against 45 food allergens
• 1 plate is sufficient for 2 patients
1
Serum
A8621
Prescreen 1
1
• Prescreen 1
• 1 plate is sufficient for 4 Patients
against 23 common food allergens for screening
purposes
Serum
A8921
Prescreen 2
1
• Prescreen 2
• 1 plate is sufficient for 4 Patients
against 23 common food allergens for screening
purposes
Serum
A8929
Reagents
Set of reagents for an enzyme immunoassay
for the determination of circulating allergenspecific IgG in serum
• sufficient for 15 plates
15
Serum
A8020
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
11
Allergy Diagnostics
Immunoblots
Product
Description
RIDA®
Immunoblots for antibody analysing
Tests
Matrix
Art. No.
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
• 20 respiratory allergens
in reaction troughs
10
Serum
A2242
• 20 food allergens
in reaction troughs
10
Serum
A2342
• 20 allergens / pediatric panel
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
12
Allergy Diagnostics
Cellular Allergy Diagnostics
Product
Functional allergy diagnostics by
detecting the symptom causing
agent: histamine
New!
Description
Tests
Matrix
Art. No.
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
• Microtiter plates coated with 10 food allergens
in 6 diff. concentrations
10
Heparinized
blood
RLA213FOOD
Plate format DERMA PANEL Fluorescence assay for allergen induced
• Microtiter plates coated with 10 dermatological
related allergens in 6 diff. Concentrations
10
Heparinized
blood
RLA214-DER
Plate format FOOD ASIA
PANEL
• Microtiter plates coated with 10 food allergens
in 6 diff. concentrations
10
Heparinized
blood
RLA223FOOD
Plate format INHALATION
ASIA PANEL
• Microtiter plates coated with 10 respiratory
allergens in 6 diff. concentrations
10
Heparinized
blood
RLA222-INH
Plate format CUSTOMER
DESIGNED*
• Microtiter plates coated with 10 customer
designed allergens
10
Heparinized
blood
RLA800-CD
Plate format CUSTOMER
MATERIAL
• Microtiter plates coated with histamine and
anti-IgE
• For the usage of own prepared allergens
10
Heparinized
blood
RLA211-CM
Strip format VARIOUS
ALLERGENS*
• 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
• 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)
120
Heparinized
blood
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
13
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 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, 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
Parasites
• Campylobacter
• Clostridium difficile GDH
(Glutamate dehydrogenase)
• E. coli O157
• Cryptosporidium
• Entamoeba
• Giardia
Toxins
• Adenovirus
• Astrovirus
• Norovirus
• Rotavirus
• Clostridium difficile Toxin A/B
• Clostridium perfringens Enterotoxin
• Verotoxins (Shigatoxins)
Viruses
14
ELISA
Product
Description
RIDASCREEN®
Enzym immunoassays for antigen detection
Tests
Matrix
Art. No.
Adenovirus
Enzyme immunoassay for the detection of
Adenoviruses
96
stool
C1001
Astrovirus
Astroviruses
96
stool
C1301
Campylobacter
Campylobacter
96
stool
C2401
Clostridium difficile
Toxin A/B
the toxins A and B of C. difficile
96
stool
C0801
Clostridium difficile GDH
glutamate dehydrogenase of Clostridium difficile
96
stool
C0701
Clostridium perfringens
Enterotoxin
Enzyme immunoassay for detection of
enterotoxin of C. perfringens
96
stool
C0601
Cryptosporidium
Cryptosporidium parvum
96
stool
C1201
Entamoeba
Entamoeba histolytica/dispar
96
stool
C1701
Giardia
Giardia lamblia
96
stool
C1101
Norovirus
Noroviruses
96
stool
C1401
C1401US*
Rotavirus
Rotaviruses
96
stool
C0901
Verotoxin
verotoxins 1 and 2 (Shigatoxins 1 and 2) of
E. coli bacteria
96
stool
mTSBBouillon
C2201
mTSB-bouillon with Mitomycin C for the
enrichment of verotoxin (shigatoxin)-producing
E. coli bacteria
100
25
RIDA®
Enrichment broth
* Only for sale in the US
15
Z1000
Z1003
FDA cleared
Rapid
Product
Description
RIDA®QUICK
Rapid assays for antigen detection
Tests
Matrix
Art. No.
Campylobacter
Single pouched cassettes
25
stool
N2403
Toxin A/B
25
stool
N0803
Cryptosporidium
Box with strips
Immunochromatographic rapid assay for the
detection of Cryptosporidium parvum
25
stool
N1202
Cryptosporidium
20
stool
N1203
Cryptosporidium/
Giardia Combi
Box with strips
detection of Cryptosporidium parvum and/or
Giardia lamblia
25
stool
N1122
Cryptosporidium/
Giardia Combi
20
stool
N1123
Cryptosporidium/
Giardia/Entamoeba
Combi
Box with strips
detection of Cryptosporidium and/or Giardia
and/or Entamoeba
25
stool
N1722
Cryptosporidium/
Giardia/Entamoeba
Combi
20
stool
N1723
Entamoeba
Box with strips
detection of Entamoeba histolytica/dispar
25
stool
N1702
Entamoeba
20
stool
N1703
Giardia
Box with strips
detection of Giardia lamblia
25
stool
N1102
Giardia
20
stool
N1103
Norovirus
Immunochromatographic Flow Through rapid
assay for the detection of Noroviruses
20
stool
N1403
Norovirus
Immunochromatographic Lateral Flow rapid
assay for the detection of Noroviruses
25
stool
N1402
Rotavirus
20
stool
N0903
Rotavirus/Adenovirus
Combi
Box with strips
detection of Rotaviruses and/or Adenoviruses
25
stool
N1002
Combi
20
stool
N1003
Verotoxin/0157
Combi
Box with strips
detection of verotoxins and/or E. coli O157
25
mTSBBouillon
N2202
Verotoxin/0157
Combi
20
mTSBBouillon
N2203
mTSB-Bouillon with Mitomycin C for the
enrichment of verotoxin (shigatoxin)-producing
E. coli bacteria
25
RIDA®
Enrichment broth
16
Z1003
Controls
Product
Description
Volume
Matrix
Art. No.
Controls for RIDA®QUICK Rapid assays
Campylobacter
Positive control
1.8 ml
NP2404
Toxin A/B
Positive control
1.8 ml
NP0804
Norovirus
Positive control
1.8 ml
NP1404
Parasite
Combi Control
Positive control
1.8 ml
NP1704
Combi Control
Positive control
1.8 ml
NP1904
Verotoxin/O157
Combi Control
Positive control
1.8 ml
NP2204
Accessories for RIDASCREEN® and RIDA® Antigen Detection tests see:
RIDA®QUICK
Sample diluent
tubes with 1.5 ml sample diluent
17
25
stool
ZN1004
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.
New!
All RIDASCREEN® Sero ELISA test kits contain two additional controls for
quality assurance purposes.
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 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® 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.
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.
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.
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
18
New!
Sero ELISA
Product
Description
RIDASCREEN®
Enzyme immunoassays for antibody detection
Adenovirus lgA
Adenovirus lgG
All RIDASCREEN® Sero ELISA
test kits contain two additional
controls for quality assurance purposes
Tests
Matrix
Art. No.
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
96
96
Serum
Serum
K1011
K1021
Bordetella lgA
Bordetella lgG
Bordetella lgM
IgA, IgG or IgM antibodies against Bordetella
pertussis and parapertussis
Differentiation between infections and immune
status after vaccination
96
96
96
Serum
Serum
Serum
K2511
K2521
K2531
Borrelia lgG
Borrelia lgM
96
IgG or IgM antibodies against Borrelia burgdorferi 96
sensu lato
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
100
100
CSF
CSF
KLiq3221
KLiq3231
Candida lgA
Candida lgG
Candida lgM
IgA, IgG or IgM antibodies against Candida
albicans and other antigenetically related
Candida species
96
96
96
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
96
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
Serum
K6621
EBV VCA lgG
EBV VCA lgM
IgG or IgM antibodies against structure proteins
(VCA = virus capsid antigen) of the Epstein-BarrVirus (EBV)
96
96
Serum
Serum
K6721
K6731
Helicobacter lgA
Helicobacter lgG
IgA or IgG antibodies against Helicobacter pylori
96
96
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-SimplexViruses (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)
96
96
96
96
Serum
K5121
Serum
K5131
Serum
K5221
Serum
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)
96
96
Serum
K5021
Serum
K5031
Influenza A lgA
Influenza A lgG
Influenza B lgA
Influenza B lgG
IgA or IgG antibodies against Influenza viruses of
type A or B
96
96
96
96
Serum
Serum
Serum
Serum
K6311
K6321
K6411
K6421
19
All RIDASCREEN® Sero ELISA
test kits contain two additional
controls for quality assurance purposes
New!
Sero ELISA
Product
Description
RIDASCREEN®
Tests
Matrix
Art. No.
Masern/Measles Virus lgG
Masern/Measles Virus lgM
IgG or IgM antibodies against Measles virus
IgG-analysis in international units (IU/ml)
96
96
Serum
Serum
K5421
K5431
Mumps Virus lgG
Mumps Virus lgM
IgG or IgM antibodies against Mumps virus
96
96
Serum
Serum
K5521
K5531
Mycoplasma pneumoniae
lgA
lgG
lgM
IgA, IgG or IgM antibodies against Mycoplasma
pneumoniae
96
Serum
K4311
96
Serum
K4321
96
Serum
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
96
96
Serum
Serum
K5811
K5821
IgG or IgM antibodies against Parvovirus B19
Detection of antibodies against recombinant VP1
and VP2; Differentiation between acute
and past infection with Parvovirus B19
96
96
Serum
Serum
K6021
K6031
RSV lgA
RSV lgG
RSV lgM
IgA, IgG or IgM antibodies against Respiratory
Syncytial Virus (RSV)
96
96
96
Serum
Serum
Serum
K5911
K5921
K5931
Tetanus lgG
IgG antibodies against the tetanus toxoid
Analysis in international units (IU/ml)
96
Serum
K3721
VZV lgA
VZV lgG
VZV lgM
IgA, IgG or IgM antibodies against
Varicella-Zoster-Virus (VZV)
Use of purified glycoprotein for IgG-detection
96
96
96
Serum
Serum
Serum
K5611
K5621
K5631
New! Parvovirus B19 lgG
Parvovirus B19 lgM
20
Parasite Diagnostics
Product
Description
RIDASCREEN®
Tests
Matrix
Art. No.
Echinococcus lgG
IgG antibodies against Echinococcus granulosus
and Echinococcus multilocularis
96
Serum
K7621
Entamoeba histolytica IgG
IgG antibodies against Entamoeba histolytica
96
Serum
K1721
Leishmania Ab
IgG antibodies against Leishmania
96
Serum
K7121
Taenia solium lgG
IgG antibodies against the larval forms of Taenia
solium (cysticercosis)
96
Serum
K7721
Toxocara lgG
IgG antibodies against Toxocara canis
96
Serum
K7421
Trichinella lgG
IgG antibodies against Trichinella spiralis
96
Serum
K7521
Please contact R-Biopharm AG for automatic solutions
Chlamydia Diagnostics
RIDASCREEN®
Chlamydia IgG/IgM
IgG or IgM antibodies against LPS antigen
(LPS = lipopolysaccharide) of Chlamydia
96
Serum
KGM3101
Chlamydia trachomatis
IgA
Chlamydia trachomatis
IgG/IgM
IgA, IgG or IgM antibodies against outer
membrane protein complex
(COMP = Complexes of Outer Membrane
Proteins) of Chlamydia trachomatis
96
Serum
K2911
96
Serum
KGM2901
Chlamydophila
pneumoniae lgA
Chlamydophila
pneumoniae lgG
Chlamydophila
pneumoniae lgM
IgA, IgG or IgM antibodies against outer
membrane protein complex
(COMP = Complexes of Outer Membrane
Proteins) of Chlamydophila pneumoniae
96
Serum
K2811
96
Serum
K2821
96
Serum
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
Accessories for RIDASCREEN® and RIDA® Antibody Detection tests see:
21
50
Serum
Z0202
Western blots and Line blots for specific antibody detection
Product
Description
Tests
Matrix
Art. No.
RIDA®BLOT and RIDA®LINE – Western blots and Line blots
New!
New!
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
20
20
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
20
20
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
22
Immunofluorescence assays for antibody detection
Product
Description
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
Tests
Matrix
Art. No.
10 x 30
Serum
I8521
10 x 30
Serum
I8525
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
23
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) and respiratory 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
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.
RIDA®GENE
& Toxin A/B LC
CD Toxin A/B LC
Norovirus LC
& Toxin A/B V
CD Toxin A/B V
Norovirus V
HyperTox
CD Toxin A/B
EAEC
Norovirus
Real-time PCR instrument
Roche
MRSA
Hospital Stool Panel
EHEC/EPEC
ETEC/EIEC
STEC
Bacterial Stool Panel
Flu
Norovirus I & II
Rotavirus/Adenovirus Duplex
Parasitic Stool Panel
LightCyler® 1.5

LightCyler® 2.0

LightCyler® 480

Cepheid
SmartCycler ®
1
Applied
Biosystems
ABI 7000

ABI 7300

ABI 7500

ABI 7700


ABI 7900 HT


StepOne

Abbott
m2000rt




Stratagene
Mx3000P




MX3005P




Qiagen
Rotor-Gene Q



3
MRSA LC2.0
STEC LC2.0
Flu LC2.0
Norovirus I & II
LC2.0
3


2

1
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.
RIDA®GENE Color Compensation Kit I required RIDA®GENE Color Compensation Kit II required 1
2
3
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
24
Gastrointestinal Infections
Product
Description
RIDA®GENE
Real-time PCR
EHEC/EPEC
Tests
Matrix
Art. No.
Real-time multiplex PCR for the direct qualitative
100
detection and differentiation of EHEC, STEC, EPEC
and EIEC/Shigella spp. in human stool samples
and culture
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
detection and differentiation of ETEC and EIEC/
Shigella spp. in human stool samples and culture
100
stool/
culture
PG2225
STEC
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
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
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
human stool samples
100
stool
PG1405LC
Norovirus*
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
norovirus genogroup I and genogroup II on the
LightCycler® 2.0 in human stool samples
100
stool
PG1425
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
100
detection and differentiation of Giardia lamblia,
Entamoeba histolytica, Cryptosporidium parvum
and Dientamoeba fragilis in human stool samples
stool
PG1705
* soon available
25
Hospital Acquired Infections
Product
Description
RIDA®GENE
Real-time PCR
Tests
Matrix
Art. No.
MRSA
detection of MRSA in human nasal swabs and
culture
100
nasal swab/
culture
PG0605
MRSA LC2.0
detection of MRSA on the LightCycler® 2.0
in human nasal swabs and culture
100
nasal swab/
culture
PG0625
Hospital Stool Panel
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
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
Clostridium difficile toxin A (tcdA) and toxin B
(tcdB) genes in human stool samples
100
stool
PG0825V
CD Toxin A/B LC
100
stool
PG0825LC
CD Toxin A/B
100
stool
PG0825
HyperTox
detection and differentiation of the hypervirulent
Clostridium difficile ribotype 027 and the 078-likegroup in human stool samples
50
stool
PG0855
26
Respiratory Infections
Product
Description
RIDA®GENE
Real-time PCR
Tests
Matrix
Art. No.
Flu
Influenza A, Influenza B and H1N1v in human
nasal swabs and throat swabs
100
nasal swab/
throat swab
PG0505
Flu LC2.0
Influenza A and Influenza B on the LightCycler®
2.0 in human nasal swabs and throat swabs
100
nasal swab/
throat swab
PG0525
27
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 pentose-phosphate-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 transketolaselike 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.
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.
Since 1996 TKTL1 is a matter of active
research and many studies appeared on the
28
Tumor Diagnostics
Pento
Pento
Pento
PentoCheck
Check
Check
CheckIHC
IHC
IHC
IHC(T001)_FINAL.qxp
(T001)_FINAL.qxp
(T001)_FINAL.qxp
(T001)_FINAL.qxp 22.11.2006
22.11.2006
22.11.2006
22.11.2006 12:19
12:19
12:19
12:19 Seite
Seite
Seite
Seite2222
Primary Antibodies
®®®®
®®®® Description
Product
RIDA
RIDA
RIDA
RIDA
PentoCheck
PentoCheck
PentoCheck
PentoCheck
IHC
IHC
IHC
IHC(T001)
(T001)
(T001)
(T001)
®
RIDA
PentoCheck®
Analysis
Analysis
Analysis
Analysis
Tests
Matrix
Art. No.
Primary Antibodies for immunohistochemistry
Analysis
Analysis
Analysis
Analysis
can
can
can
can
be
be
be
be
performed
performed
performed
performed
using
using
using
aalight
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light
light
optical
optical
optical
optical
microscope
microscope
microscope
microscope
or
or
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an
an
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following
following
following
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scoring
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system
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isisis
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recommended
aaaa
RIDA®PentoCheck®
IHC using
monoclonal
mouseororantibody
for the
detection
of
200
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T001asasasas
automated
automated
automated
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manner
manner
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ACIS
ACIS
ACIS
ACIS
11;
11;
11;
11;
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automated
automated
automated
digital
digital
digital
digital guideline
guideline
guideline
guideline
for
for
for
for
the
the
the
the
non-automated
non-automated
non-automated
non-automated
analysis
analysis
analysis
analysis
ofofof
tissue
oftissue
tissue
tissue
sections
sections
sections
sections
mAb
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(IgG2b)
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1
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(TKTL1)
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system).
system).
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Analysis
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by
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––Score
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0:0:0:
0: 00-00-20
-20
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20
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––Score
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1:1:1:
1: 21
21
21
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3:3:3:
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trained
trained
trained
trained
personnel
personnel
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under
under
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the
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System for evaluation of TKTL1 staining intensity in micro-array sections (AEC and hematoxylin)
Score 0
Score
Score
Score
Score
0000
Score 1
Score
Score
Score
Score
1111
Score 2
29
Score
Score
Score
Score
2222
Score 3
Score
Score
Score
Score
3333
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 inflammatory 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 diagnosis 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.
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)
30
Gastroenterology
ELISA
Product
Description
RIDASCREEN®
Enzyme immunoassays
Tests
Matrix
Art. No.
Haemoglobin
haemoglobin
96
stool
G09030
Haemo-/Haptoglobin
Complex
haemoglobin/haptoglobin complex
96
stool
G09031
α1-Antitrypsin
α1-Antitrypsin
96
stool
G09034
sIgA
secretoric IgA
96
stool
G09035
New! Calprotectin
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 validation
RIDASCREEN® Haemoglobin G09030
also see:  Instruments / Software / Accessories
* available in many European countries. Please contact R-Biopharm for more information.
31
48
GZ3002
48
GZ3006*
48
GZ3003
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,
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.
32
Accessories
Product
Description
Tests
Matrix
Art. No.
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
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 database, the patient database and for measurement,
evaluation and documentation of RIDASCREEN®
ELISA allergy diagnostics (total IgE, spec. IgE and
IgG)
Z9997
Vitamin Detection
RIDASCREEN®
Enzyme binding assays for vitamin detection
Biotin
Quantitative detection of biotin in serum
33
96
Serum
H1601
The R-Biopharm Group
R-Biopharm AG
R-Biopharm Inc.
R-Biopharm
España S.A.
R-Biopharm
Latinoamérica
R-Biopharm
Rhône Ltd.
R-Biopharm
France
R-Biopharm
Brasil Ltda.
R-Biopharm
Italia Srl.
R-Biopharm
China
R-Biopharm
Australia
subsidiaries
distributors
R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany
Phone: +49 (0) 61 51 - 81 02-0
Fax: +49 (0) 61 51 - 81 02-40
E-mail: [email protected]
[email protected]
www.r-biopharm.com
34
Contact Details
Division Management Clinical Diagnostics
Clinical Sales International
Dr. Wolfgang Schartl
Division Management Clinical Diagnostics
Phone: +49 (0) 61 51 - 81 02-30
Fax: +49 (0) 61 51 - 81 02-688
Product Management
International Sales Manager Asia / MENA
Dr. Dieter Gernet
Phone: +49 (0) 61 51 - 81 02-28
Director Clinical Sales International Jens-Uwe Wünsch
Phone: +49 (0) 61 51 - 81 02-995
Fax: +49 (0) 61 51 - 81 02-40
Allergy Diagnostics
Joachim Zehender
Product Manager Allergy Diagnostics Phone: +49 (0) 61 51 - 81 02-45
International Sales Manager Europe / Africa
Dr. Otto Mannherz
Phone: +49 (0) 61 51 - 81 02-446
Hannah Gören
Product Specialist Allergy Diagnostics
Phone: +49 (0) 61 51 - 81 02-429
E-Mail: [email protected]
International Sales Manager
CIS Mongolia, Caucasus
Anatolii Buk
Phone: +49 (0) 61 51 - 81 02-19
Infectious Diseases (Antigen Detection)
Helmut Leidinger
Product Manager Stool Diagnostics
Phone: +49 (0) 61 51 - 81 02-26
Support Sales International
Martina Scheidenberger
Phone: +49 (0) 61 51 - 81 02-52
Carsten Müller
Phone: +49 (0) 61 51 - 81 02-440
Infectious Diseases (Antibody Detection)
Dr. Johanna Endt
Product Manager Serological Diagnostics
Phone: +49 (0) 61 51 - 81 02-774
Andrea Becker
Phone: +49 (0) 61 51 - 81 02-531
Gastroenterology
Dr. Andrea Lennerz
Product Manager Gastroenterology
Phone: +49 (0) 61 51 - 81 02-632
Order Department
General contact
Phone: +49 (0) 61 51 - 81 02-0
Fax: +49 (0) 61 51 - 81 02-20
Stephanie Weil
Product Specialist Gastroenterology
Phone: +49 (0) 61 51 - 81 02-736
Project Manager Infectious Diseases
Dr. Andreas Simons
Project Manager Infectious Diseases
Product Manager Molecular Diagnostics
Phone: +49 (0) 61 51 - 81 02-96
Africa
Jutta Wien
Phone: +49 (0) 61 51 - 81 02-14
Asia, Switzerland
Ingrid Illich
Phone: +49 (0) 61 51 - 81 02-61
Europe
Monika Fröhlich
Phone: +49 (0) 61 51 - 81 02-764
Janina Drynski
Product Specialist Molecular Diagnostics
Phone: +49 (0) 61 51 - 81 02-410
Eastern Europe
Petra Vlasak
Phone: +49 (0) 61 51 - 81 02-82
Secretary
North, Middle- and South-America, Oceania
Christoph Polzin
Phone: +49 (0) 61 51 - 81 02-54
Petra Schorr
Phone: +49 (0) 61 51 - 81 02-23
35
36
General Terms & Conditions of R-Biopharm AG
(Date of Issue: October 2010)
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.
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.
VII. Warranty / Liability
1. 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.
III. Prices and Conditions of Payment / Withdrawal in case of default
1. 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 Title
1. 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. Delivery
1. 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.
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 Jurisdiction
1. 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.
VI. Shipment and Passing of Risk
1. 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
37
38
39
03/2012
R-Biopharm AG, An der neuen Bergstraße 17, 64297 Darmstadt, Germany
Phone: +49 (0) 61 51 - 81 02-0, Fax: +49 (0) 61 51 - 81 02-20
40
R-Biopharm
AG – Product Catalogue 2012
www.r-biopharm.com

R-Biopharm Product Catalogue, Clinical Diagnostics 2012

Transcription

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