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rapid diagnostics ELISA / LINE assays DISEASE INFECTIOUS INFECTIOUS DISEASE 2015/2016 Product Catalog

TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

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Page 1: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

r a p i d d i a g n o s t i c s

E L I S A / L I N E a s s a y s

D I S E A S EI N F E C T I O U SI N F E C T I O U S D I S E A S E

2 0 1 5 / 2 0 1 6 P roduc t Ca ta log

Page 2: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

4 INF

ELISA ASSAYS

The Virotech ELISA assays deliver qualitative, semi-quantitative and quantitative results for all important parameters of Infectious

Disease Serology. They are intended for the detection of specific IgG-, IgM- and IgA antibodies in human serum.

They are suitable for use on automated Immunoassay Analyzers and have been successfully evaluated on devices such as

BEP III, DSX, Freedom EVOlyzer, ETI MAX 3000, Triturus and Thunderbolt (in evaluation). The ELISAs are thus released on these

devices referring to the IVD directive 98/79/EC. In addition to serology the Virotech ELISAs can also be used for the detection of

pathogen-specific antibodies in Cerebrospinal Fluid (CSF).

For determining the accuracy and precision of the antibody index (AI), specific Antibody-Index-Controls (AI-Controls) are

offered. These AI-Control pairs for the normal range and the pathological range allow comprehensive quality control in daily

laboratory routine for the diagnosis of Cerebrospinal Fluid parameter.

ELISA ADVANTAGES

• Uniform serum dilution

• General IgG-, IgM-, IgA-conjugate

• Uniform incubation times

• Uniform interpretation with ready to use cut-off controls

• Ready to use controls, conjugates, substrates

• Automatable

CSF DIAGNOSTIC ADVANTAGES

• User friendly Serum- & CSF-Dilution

• Identical Serum-/CSF-Dilution for all available Serum-/CSF ELISAs

• Antibody-Index (AI)-determination referring to

the Reiber-diagraphs

• Excellent precision and reliability shown in the German proficiency testing

• Software-based calculation of the CSF data possible

• Paralell CSF/ Serum procedure on one plate (including serology)

• Ideal elimination of the Matrix-effect

• Ready-to-use CSF-standards

ANTIBODY-INDEX-CONTROL (AI-CONTROL) ADVANTAGES

• Verification of the accuracy and precision of the determined AI

• Qualitiy Control in the daily CSF-routine-diagnostic

• CSF/Serum-Control Pair for the normal range (AI <1,5) ready to use

• CSF/Serum-Control Pair for the pathologic range (AI >1,5) ready to use

The Virotech ELISA System

Page 3: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY / ELISA

PRODUCT FORMAT ORDER NUMBER FEATURES

INF 5

Adenovirus ELISA

IgG / IgM Testkit 96 wells EC121.00 Can be processed in one run with all other kits

IgA Set Set EC121.08 of the respiratory panel

Bordetella pertussis ELISA

IgG / IgA Testkit 96 wells EC115.00 Sensitive Screening due to use of combined

antigens PT and FHA

Pertussis Toxin ELISA

IgA Testkit 96 wells EC215A00 Highly specific and sensitive diagnostics due to use

IgG Testkit 96 wells EC215G00 of pure Pertussis Toxin. Quantitative IgG detection

IgG-Quantification-Set 3 x 2 mL EN215Q60 in IU/mL (WHO-Std) via 4PL-method by

IgM Testkit 96 wells EC215M00 using the IgG quantification set

Borrelia afzelii + VIsE IgG ELISA

IgG Testkit 96 wells EC022G00 Maximum diagnostic sensitivity and good

IgG CSF Standards Standards EC022L60 specificity due to an antigen mix of B. afzelii strain

IgG Antibody-Index-Control 4 x 1 mL EN022L65 PKo, B. garinii strain PBr and B. burgdorferi

strain ZS7

Borrelia afzelii +VIsE Europe ELISA

IgG Testkit 96 wells EC024G00 Increased specificity due to a special

IgG CSF Standards Standards EC022L60 cut-off adjustment

IgG Antibody-Index-Control 4 x 1 mL EN022L65

Borrelia afzelii IgM ELISA

IgM Testkit 96 wells EC022M00 High sensitivity due a strong expressing

IgM CSF Standards Standards EC022L80 OspC-Borrelia afzelii-strain Pko

Borrelia VIsE IgG ELISA

IgG Testkit 96 wells EC023G00 High-specific Screening Assay, coated solely with

the in vivo expressed antigen VlsE

Borrelia burgdorferi Veterinary ELISA

IgG Testkit dog/horse 96 wells DC122.00 Sensitive IgG antibody screening of dog or

IgM Set dog Set DC122K80 horse serum

Brucella ELISA

IgG / IgM Testkit 96 wells EC101.00 Detects Brucella abortus, Brucella

IgA Set Set EC101.08 melitensis and Brucella suis

Candida albicans ELISA

IgG / IgM Testkit 96 wells EC111.00 Adjusted to primarily detect acute

IgA Set Set EC111.08 infections in IgG

CMV ELISA

IgG / IgM Testkit 96 wells EC113.00 Very sensitive mix of native and

IgG CSF Standards Standards EC113L60 recombinant antigens

Diphtheria ELISA

IgG Testkit 96 wells EC129.00 Usable for survey of vaccination status and

vaccination success. Aligned with WHO standards

for quantitative detection in IU/mL via 4PL-method

or 6 standards

EBV ELISA

IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA

IgG CSF Standards Standards EC102L60 A diagnostic statement with regard to

IgG Antibody-Index-Control 4 x 1 mL EN102L65 seronegativity, suspicion to an EBV primary

infection or past EBV infection can be made

when combining the two antibody classes

EBV EA-D ELISA

IgG Testkit 96 wells EC202.00 “Early Antigen-Diffuse” belongs to the early

antigens, which are synthesised in the viralreplication cycle (acute phase of infection)

Please note that some products listed may not be available in all markets.

Page 4: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY / ELISA

PRODUCT FORMAT ORDER NUMBER FEATURES

6 INF

ELISA ASSAYS

EBV EBNA 1 ELISA

IgG Testkit 96 wells EC204.00 Diagnostic factor for a clear differentiation

between primary infection and past infection

at a positive result of EBNA1-IgG and VCA-IgM

EBV VCA IgG ELISA

IgG Testkit 96 wells EC205G00 Includes the important high specific markers

for EBV: gp125 and p18

EBV VCA IgM ELISA

IgM Testkit 96 wells EC203M00 Diagnostic factor for a clear differentiation

between primary infection and past infection

at a positive result of EBNA1-IgG and VCA-IgM

Enterovirus ELISA

(Coxsackie- and Echovirus)

IgA Testkit 96 wells EC116A00 Coxsackievirus B5 and Echovirus 24: Screening

IgG Testkit 96 wells EC116G00 Assay for the detection of heterotypic

IgM Testkit 96 wells EC116M00 IgG-, IgA-, IgM-antibodies

Helicobacter pylori ELISA

IgA Testkit 96 wells EC143A00 Sensitive detection of specific IgG- and

IgG Testkit 96 wells EC143G00 IgA-antibodies

HSV 1 (gG1) ELISA

IgG / IgM Testkit 96 wells EC130.00 High-specific recombinant glycoprotein gG1

IgG CSF Standards Standards EC130L60

HSV 2 (gG2) ELISA

IgG / IgM Testkit 96 wells EC131.00 High-specific affinity-purified glycoprotein gG2

IgG CSF Standards Standards EC131L60

HSV Screen ELISA

IgG / IgM Testkit 96 wells EC108.00 Screening of IgG and IgM of HSV 1and HSV 2

IgG CSF Standards Standards EC108L60 in one assay

IgA Antibody-Index-Control 4 x 1 mL EN108L45

IgG Antibody-Index-Control 4 x 1 mL EN108L65

Influenza A ELISA

IgG / IgM Testkit 96 wells EC118.00 Up to date antigens as per seasonal

IgA Testkit 96 wells EC118A00 recommendation of the WHO

Influenza B ELISA

IgG / IgM Testkit 96 wells EC119.00 Up to date antigens as per seasonal

IgA Testkit 96 wells EC119A00 recommendation of the WHO

Measles ELISA

IgG Testkit 96 wells EC105G00 Complete package of serum and

IgM Testkit 96 wells EC105M00 CSF diagnostic

IgG CSF Standards Standards EC105L60

IgM CSF Standards Standards EC105L80

IgG Antibody-Index-Control 4 x 1 mL EN105L65

Mumps ELISA

IgG / IgM Testkit 96 wells EC106.00 Complete package of serum and

IgG CSF Standards Standards EC106L60 CSF diagnostic

Mycoplasma pneumoniae ELISA

IgG / IgM Testkit 96 wells EC114.00 Cut-off adjustment to detect acute infections

IgA Set Set EC114.08 in IgG. Specific infants cut-off adjustment.

Mycoplasma pn. polyvalent ELISA

IgG/IgA+M Testkit 96 wells EC214.00 Efficient diagnostic due to simultaneous detection

of IgA & IgM antibodies with one polyvalentconjugate. Cut-off adjustment to detect acute infections in IgG. Specific infants cut-off adjustment.

Please note that some products listed may not be available in all markets.

Page 5: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY / ELISA

PRODUCT FORMAT ORDER NUMBER FEATURES

INFECTIOUS DISEASE SEROLOGY / ELISA — PREABSORPTION OF RHEUMATOID FACTORS

PRODUCT FORMAT ORDER NUMBER FEATURES

INF 7

ParaScreen ELISA

IgG / IgM Testkit 96 wells EC148.00 Detects Parainfluenza 1-3 in one test run

IgA Set Set EC148.08

RSV ELISA

IgG / IgM Testkit 96 wells EC107.00 Can be processed in one run with all other kits

IgA Set Set EC107.08 of the respiratory panel

Rubella ELISA

IgG CSF Testkit 96 wells EC109L00 CSF Diagnostic for IgG, AI-Controls for IgG

IgG CSF Standards Standards EC109L60

IgG Antibody-Index-Control 4 x 1 mL EN109L65

TBE ELISA

IgG / IgM Testkit 96 wells EC117.00 Sensitive detection of an acute or recent infection

IgG CSF Standards Standards EC117L60 with Tick-Borne-Encephalitis-Virus (TBE) or for the

IgM CSF Standards Standards EC117L80 detection of vaccination antibodies

IgG Antibody-Index-Control 4 x 1 mL EN117L65

Tetanus ELISA

IgG Testkit 96 wells EC124.00 Survey of vaccination status and vaccination

success, routinely aligned with WHO standards

for quantitative detection in IU/ml via

4PL-method or 6 standards

VZV ELISA

IgG / IgM Testkit 96 wells EC110.00 IgG adjusted as recommended by the

IgA Set Set EC110.08 Robert-Koch-Institute (aligned to the WHO

IgA CSF Standards Standards EC110L40 standard: > 100IU/l = seropositive titer)

IgG CSF Standards Standards EC110L60

IgM CSF Standards Standards EC110L80

IgG Antibody-Index-Control 4 x 1 mL EN110L65

Yersinia enterocolitica ELISA

IgG / IgA Testkit 96 wells EC142.00 Mix of purified native antigens and recombinant

antigens YopD, YopB & YopE

RF-SorboTech vial – 2 mL 161101 Rheumatoid factor absorbent for all IgM and

IgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech vial – 10 mL 161102 Rheumatoid factor absorbent for all IgM and

IgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech 80x 2 vials RF – 2 mL, B/300.00 Rheumatoid factor absorbent for all IgM and

dilution buffer IgA+M ELISA tests and Pertussis Toxin IgA ELISA

RF-SorboTech Kit 1 vial RF – 2 mL, B/300.11 Rheumatoid factor absorbent for all IgM and

40 tubes with IgA+M ELISA tests and Pertussis Toxin IgA ELISA

450 µl dilution

buffer each

Please note that some products listed may not be available in all markets.

Page 6: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY / ELISA — SINGLE COMPONENTS FOR HUMAN SEROLOGY EIA

PRODUCT FORMAT ORDER NUMBER

ELISA ASSAYS

8 INF

Tetramethylbenzidine – Substrate Solution 11 mL 151101

PBS-Washing Solution (20x concentrated) 50 mL 141201

Citrate-Stopping Solution 6 mL 141101

PBS-Dilutionbuffer (blue, ready to use) 50 mL 141301

VZV-IgM-Dilutionbuffer (green, ready to use) 50 mL 141401

IgA-Conjugate (anti-human) 11 mL 131301

IgA-Conjugate 2 (anti-human) 11 mL 131601

IgA+M Conjugate 11mL 131401

IgG-Conjugate (anti-human) 11 mL 131101

IgM-Conjugate (anti-human) 11 mL 131201

12 breakable microtiter strips (antigen-coated) 1 Plate ECXXX.01

IgA Set (IgA-Controls and IgA-Conjugate) Set ECXXX.08

IgA-Controls Set ENXXXK40

IgG-Controls Set ENXXXK60

IgM-Controls Set ENXXXK80

Diphtheria ELISA Set EN129K60

IgG Standard-Control-Set

Tetanus ELISA Set EN124K60

IgG Standard-Control-Set

XXX = order number of the parameter (refer to the product list). Please note that the control sets are kit-specific.

Please always indicate the batch-number of the kit they are intended to be used with.

Please note that some products listed may not be available in all markets.

Page 7: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

VALIDATION OF ELISA PROCESSORS

PRODUCT FORMAT ORDER NUMBER FEATURES

VIROTECH ELISA ASSAYS - PACKAGE CONTENTS

INF 9

Validation Kit, ELISA 96 wells EC250.00 Kit to verify ELISA devices (semi- or fully automated)

Pipetting Control-Set 2.5 mL EN250K60 Set to verify the pipetting process of ELISA devices

(semi- or fully automated). For use with EC250.00

Semiquantitative ELISA Testkits, ECXXX.00

• 12 separable microtiter strips

• Anti-human conjugates: IgA, IgG, IgM, depending

on test format

• Controls: negative, cut-off, positive, IgA, IgG, IgM,

depending on test format

• dilution buffer, washing buffer

Tetanus (EC124.00) and Diphtheria (EC129.00) ELISA,

quantitative Assays

• additional 6 standard sera to create a standard curve

CSF-Standards, ECXXXL40/ECXXXL60/ECXXXL80

• 4 IgA-CSF standards, IgM-CSF standards or IgG-CSF

standards to prepare a standard curve. For the

parallel detection of specific IgA-, IgM-

or IgG-antibodies in Cerebrospinal Fluid.

ENXXXL65, ENXXXL45 Antibody-Index-Control

• CSF / Serum Control pair for the normal range

• CSF / Serum Control pair for the pathological range

ECXXX.08, IgA Set

• IgA- negative, cut-off and positive-control

• Anti-human IgA-conjugate

ECXXXK40, IgA-controls

• IgA-negative-, cut-off- and positive-control

only for Bordetella pertussis, Enterovirus,

Helicobacter pylori, Influenza A, Influenza B,

Pertussis Toxin and Yersinia enterocolitica

ENXXXK60, IgG-controls

• IgG-negative-, cut off-, positive-controls

ENXXXK80, IgM-controls

• IgM-negative-, cut off-, positive-controls

Please note that some products listed may not be available in all markets.

Page 8: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

10 INF

LINE ASSAYS

The Virotech Line Immuno Assays (LIA) are intended for the qualitative detection of pathogen-specific antibodies in human

serum. Our continuously extended product range serves for the detection of IgG-, IgM- and IgA-specific antibodies in human

serum and can be used in the uniform LINE system. The Borrelia LINEs assays can be used for the detection of specific antibodies

in Cerebrospinal Fluid. In this system, the proteins are transferred to a nitrocellulose membrane using a special micro-dispensing

method.

The Virotech LINEs are suitable for the use on Automated Immunoassay Analyzers and have been successfully evaluated on the

Tecan Profiblot.

ADVANTAGES OF THE VIROTECH LINE SYSTEM:

• Solid strips stabilised on a plastic foil

• Sorted strips in a booklet

• Clear strip numbering

• Quality control on each strip

• Identical incubation times (30´/30´/10´)

• Automatable

• Test result after 100 minutes available

• Identical serum and conjugate dilution

• General components

• Cut off control included in the Kit

• Positive-/negative controls available

The Virotech LINE System

Page 9: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY LINE

PRODUCT FORMAT ORDER NUMBER FEATURES

INF 11

B. pertussis + CatACT LINE

IgA Line Immunoblot 32 strips WE116A32 New marker CatACT allows differentiation between

IgA Line Immunoblot 96 strips WE116A96 vaccination and infection. Note towards

IgA cut off control 0,5 mL WE116C40 parapertussis possible.

IgA positive control 0,5 mL WE116P40

IgG Line Immunoblot 32 strips WE116G32

IgG Line Immunoblot 96 strips WE116G96

IgG cut off control 0,5 mL WE116C60

IgG positive control 0,5 mL WE116P60

IgG/IgA negative control 0,5 mL WE116N20

Borrelia LINE

IgG Line Immunoblot 32 strips WE222G32 Excellent specificity and sensitivity due to the

IgG Line Immunoblot 96 strips WE222G96 optimised combination of the most important

IgG cut off control 0,5 mL WE222C60 common antigens (OspC, p39, p83/100)

IgG positive control 0,5 mL WE222P60 with well-known „in-vivo“ antigens.

IgM Line Immunoblot 32 strips WE222M32 EBV-band as exclusion marker in IgM diagnostics.

IgM Line Immunoblot 96 strips WE222M96 Validated for CSF testing.

IgM cut off control 0,5 mL WE222C80

IgM positive control 0,5 mL WE222P80

IgG/IgM negative control 0,5 mL WE222N10

Borrelia in vivo LINE plus

IgG Line Immunoblot 32 strips WE223G32 Treponema-band (TpN17) as exclusion marker

IgG Line Immunoblot 96 strips WE223G96 in IgG diagnostics. Validated for CSF testing.

IgG cut off control 0,5 mL WE223C60

IgG positive control 0,5 mL WE223P60

IgG negative control 0,5 mL WE223N60

Borrelia Europe LINE

IgG Line Immunoblot 32 strips WE224G32 Optimised combination of high purified lysate

IgG Line Immunoblot 96 strips WE224G96 antigens (OspC, DbpA-PKo) and recombinant

IgG cut off control 0,5 mL WE224C60 antigens (VlsE, p83, p58, p39, DbpA-Mix).

IgG positive control 0,5 mL WE224P60 EBV-band as exclusion marker in IgM diagnostics.

IgM Line Immunoblot 32 strips WE224M32 Validated for CSF testing.

IgM Line Immunoblot 96 strips WE224M96

IgM cut off control 0,5 mL WE224C80

IgM positive control 0,5 mL WE224P80

IgG/IgM negative control 0,5 mL WE224N10

Borrelia Europe plus TpN17 LINE

IgG Line Immunoblot 32 strips WE225G32 Treponema-band (TpN17) as exclusion

IgG Line Immunoblot 96 strips WE225G96 marker in IgG diagnostics. Validated for CSF testing.

IgG cut off control 0,5 mL WE225C60

IgG positive control 0,5 mL WE225P60

IgG negative control 0,5 mL WE225N60

EBV LINE

IgG Line Immunoblot 32 strips WE102G32 Double-cut-off strategy for EBNA1-interpretation.

IgG Line immunablot 96 strips WE102G96 Tool for a clear differentiation between primary

IgG cut off control 0,5 mL WE102C60 and past infection.

IgG positive control 0,5 mL WE102P60

IgM Line Immunoblot 32 strips WE102M32

IgM Line Immunoblot 96 strips WE102M96

IgM cut off control 0,5 mL WE102C80

IgM positive control 0,5 mL WE102P80

IgG/IgM negative control 0,5 mL WE102N10

Please note that some products listed may not be available in all markets.

Page 10: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY LINE

PRODUCT FORMAT ORDER NUMBER FEATURES

12 INF

LINE ASSAYS

Helicobacter pylori LINE

IgA Line Immunoblot 32 strips WE243A32 Therapy-relevant differentiation of virulent and

IgA Line Immunoblot 96 strips WE243A96 non-virulent strains via CagA and VacA

IgA cut off control 0,5 mL WE243C40

IgA positive control 0,5 mL WE243P40

IgG Line Immunoblot 32 strips WE243G32

IgG Line Immunoblot 96 strips WE243G96

IgG cut off control 0,5 mL WE243C60

IgG positive control 0,5 mL WE243P60

IgG/IgA negative control 0,5 mL WE243N20

HSV LINE

IgG Line Immunoblot 16 strips WE130G16 High specific bands for HSV1 (gG1-recombinant)

IgG Line Immunoblot 32 strips WE130G32 and HSV2 (gG2-purified) as well as a native

IgG cut off control 0,5 mL WE130C60 total antigen band (1+2)

IgG positive control 0,5 mL WE130P60

IgG negative control 0,5 mL WE130N60

Mycoplasma pneumoniae LINE

(recomb.)

IgA Line Immunoblot 16 strips WE214A16 The only commercially available LINE, with

IgA cut off control 0,5 mL WE214C40 an ideal combination of established

IgA positive control 0,5 mL WE214P40 (P1) & new antigens (P200, P400)

IgG Line Immunoblot 16 strips WE214G16

IgG cut off control 0,5 mL WE214C60

IgG positive control 0,5 mL WE214P60

IgM Line Immunoblot 16 strips WE214M16

IgM cut off control 0,5 mL WE214C80

IgM positive control 0,5 mL WE214P80

IgG/IgA/IgM negative control 0,5 mL WE214N50

Treponema pallidum LINE

(recomb.)

IgG Line Immunoblot 16 strips WE150G16 Very good sensitivity and specificity

IgG Line Immunoblot 32 strips WE150G32 using recombinant proteins

IgG cut off control 0,5 mL WE150C60

IgG positive control 0,5 mL WE150P60

IgM Line Immunoblot 16 strips WE150M16

IgM Line Immunoblot 32 strips WE150M32

IgM cut off control 0,5 mL WE150C80

IgM positive control 0,5 mL WE150P80

IgG/IgM negative control 0,5 mL WE150N10

Yersinia enterocolitica LINE

(recomb.)

IgA Line Immunoblot 32 strips WE242A32 Prevalence band YopDD in IgG shows

IgA Line Immunoblot 96 strips WE242A96 contact with the pathogen

IgA cut off control 0,5 mL WE242C40

IgA positive control 0,5 mL WE242P40

IgG Line Immunoblot 32 strips WE242G32

IgG Line Immunoblot 96 strips WE242G96

IgG cut off control 0,5 mL WE242C60

IgG positive control 0,5 mL WE242P60

IgG/IgA negative control 0,5 mL WE242N20

Please note that some products listed may not be available in all markets.

Page 11: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

INFECTIOUS DISEASE SEROLOGY LINE — SINGLE COMPONENTS FOR LINE TEST KITS

PRODUCT FORMAT ORDER NUMBER

INFECTIOUS DISEASE SEROLOGY LINE — DOG KIT (BASIS KIT) WITH ADDITIONAL HORSE SET

PRODUCT FORMAT ORDER NUMBER FEATURES

INF 13

IgG-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.62

IgM-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.82

IgA-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.42

Dilution- / Washbuffer (10x concentrated) 50 mL WE200.08

Substrate Solution (BCIP/NBT, ready to use) 57 mL WE200.02

Incubationtray with 42 cavities, to be used with the Apollo automates 1 pcs WE300.42

Incubationtray with 30 cavities, black, to be used with the ProfiBlot automates 1 pcs WE300.30S

Incubationtray with 48 cavities, black, to be used with the ProfiBlot automates 1 pcs WE300.48S

Incubationtray with 8 cavities 1 pcs WE300.08

Record Sheet 1 booklet WE301APB

Borrelia Veterinary plus OspA LINE

IgG LINE Immunoblot dog 32 strips DE226G32 Specific LINE assay to detect the most important

IgG LINE Immunoblot dog 96 strips DE226G96 Borrelia genospecies in dog and horse serum.

IgG Horse Set Set DE226K62

Please note that some products listed may not be available in all markets.

LABIMAGE® LA- LINE INTERPRETATION SOFTWARE

PRODUCT FORMAT ORDER NUMBER FEATURES

LabImage® Package 1 F/LabImage 1 LabImage® Reader plus PC

LabImage® Software (CD)

Virotech SetCards (CD)

Manuals

LabImage® Package 2 F/LabImage 2 LabImage® Reader without PC

LabImage® Software (CD)

Virotech SetCards (CD)

Manuals

License-Dongle

LabImage® Package 3 F/LabImage 3 Flat Bed Scanner (Plustek)

LabImage® Software (CD)

Virotech SetCards (CD)

Manuals

License-Dongle

Page 12: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

14 INF

LINE ASSAYS

SERAMUN AUTOIMMUN DIAGNOSTICS – SERALINE®

PRODUCT FORMAT ORDER NUMBER FEATURES

Seraline® Zöliakie-3 IgG 20 strips HW/LIA-001-3G Line Immunoassay for detection of IgG antibodies

to Gliadin, Tissue Transglutaminase (tTG) and

Mannan in human serum or plasma.

Seraline® Zöliakie-3 IgA 20 strips HW/LIA-001-3A Line Immunoassay for detection of IgA antibodies

to Gliadin, Tissue Transglutaminase (tTG) and

Mannan in human serum or plasma.

Seraline® ANA-12 IgG 20 strips HW/LIA-002-12G Line Immunoassay for detection of IgG-antibodies

in connective tissue diseases in human serum or

plasma.

Seraline® Vaskulitis-3 IgG 20 strips HW/LIA-003-3G Line Immunoassay for detection of IgG-antibodies

in systemic vasculitis in human serum or plasma.

Seraline® HepAk-7 IgG 20 strips HW/LIA-004-7G Line Immunoassay for detection of

igG-autoantibodies in autoimmune liver diseases in

human serum or plasma.

Please note that some products listed may not be available in all markets.

SERALINE® ADVANTAGES & EXAMPLES:

• Detection of multiple auto-antibodies in one test run

• Solid strips stabilised on a plastic foil and sorted strips in a booklet

• Cut-off control on each strip

• Ready to use & coloured conjugate

SERAMUN AUTOIMMUN DIAGNOSTICS – SERALINE®

SERALINE® ZÖLIAKIE SERALINE® ANA-12 SERALINE® VASKULITIS SERALINE® HepAk PLUS

function control

IgG

IgA

Cut off control

Gliadin

tTG

Mannan

function control

Cut off control

dsNDA

Nucleosomes

Sm

P0

Histones

U1 snRNP

Ro/SS-A(60kDa)

Ro/SS-A(52kDa)

La/SS-B

Scl-70

CENP-B

Jo-1

conjugate control

function control

Cut off control

PR3

MPO

GBM

function control

Cut off control

AMA/M2

LKM1

LC1

SLA

F-Actin

gp210

Sp100

Page 13: TEST1 SD2015 PC Infectious Disease INSIDE 10-1-15 WEB...IgA Set Set EC121.08 of the respiratory panel ... IgG / IgM Testkit 96 wells EC102.00 EBV screening ELISA IgG CSF Standards

CLINICAL CHEMISTRY REAGENTS

INFECTIOUS DISEASE — ANTIGEN DETECTION ELISA WITH A SYSTEM

The Seramun Stool ELISA system is used for the qualitative detection of pathogen specific antigens/toxins in stool samples and

culture material.

Special Kit packages have been developed for the use on Automated Immunoassay Analyzers (see order numbers

ending –A2). The Kits intended for manual procedure are available in a drop-bottle-format. Seramun offers the Serazym Stool

System - meaning all reagents in the kit (except conjugate, controls and microtiter plate) can be used independent from lot

number or pathogen.

This offers significant advantages!

Seramun Stool ELISA

SERAMUN STOOL ELISA DIAGNOSTIC FEATURES

• ONE SYSTEM in pre-analytics

• Optimal results / excellent performance data

• 1 sample diluent & 1 dilution

• General lot-independent reagents (overall reagents)

• Separate controls available

• Two kit versions; one for Automated Immunoassay Analyzers and one for

manual procedure (drop-bottle-format)

• Color coded vial caps and plates for ease of use

• Removable label for wash buffer

INF 15

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16 INF

ELISA ASSAYS

SERAMUN ANTIGEN DETECTION TESTS — ELISA (TEST MATERIAL: HUMAN STOOL SAMPLES / CULTURE MATERIAL)

BACTERIA FORMAT ORDER NUMBER FEATURES

VIRUSES FORMAT ORDER NUMBER FEATURES

PARASITES FORMAT ORDER NUMBER FEATURES

Serazym® Campylobacter 96 wells HW/E-093 Specific detection of C. jejuni and C. coli in stool

Serazym® Campylobacter 2 x 96 wells HW/E-093-A2 and culture samples

Serazym® Clostridium difficile GDH 96 wells HW/E-107 Sensitive screening for the detection of

Serazym® Clostridium difficile GDH 2 x 96 wells HW/E-107-A2 Glutamatdehydrogenase of Clostridium difficile

Serazym® Clostridium difficile Toxin A + B 96 wells HW/E-040 Sensitive detection with a biotin/streptavidin

Serazym® Clostridium difficile Toxin A + B 2 x 96 wells HW/E-040-A2 conjugate system of Toxin A & B in stool

and culture samples

Serazym® Verotoxin 1 + 2 96 wells HW/E-030 Sensitive detection with a biotin/streptavidin

Serazym® Verotoxin 1 + 2 2 x 96 wells HW/E-030-A2 conjugate system of Verotoxin 1 & 2

(Shiga Toxin 1 & 2) in stool and culture samples

Serazym® Adenovirus 96 wells HW/E-017 Detection of the capsid protein hexon, common

Serazym® Adenovirus 2 x 96 wells HW/E-017-A2 to all human pathogenic Adenovirus serotypes

Serazym® Astrovirus 96 wells HW/E-045 Detection of Astrovirus specific antigens in a

Serazym® Astrovirus 2 x 96 wells HW/E-045-A2 short incubation time of 60-10 min

Serazym® Norovirus 96 wells HW/E-061 Detection of Norovirus capsid proteins

Serazym® Norovirus 2 x 96 wells HW/E-061-A2 of the genogroups GGI and GGII

Serazym® Rotavirus 96 wells HW/E-020 Detection of the major protein VP-6

Serazym® Rotavirus 2 x 96 wells HW/E-020-A2 of group A Rotaviruses

Serazym® Cryptosporidium parvum 96 wells HW/E-039-A Sensitive detection with monoclonal

antibodies

Serazym® Entamoeba histolytica 96 wells HW/E-018-A Sensitive detection of E. histolytica

while detection of E. dispar is only

possible with high organism counts ( >105 mL)

Serazym® Giardia lamblia 96 wells HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1)

despite intermittent excretion

Please note that some products listed may not be available in all markets.

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SEKISUI DIAGNOSTICS

YOUR GLOBAL PARTNER FOR OVER 30 YEARS

Sekisui Diagnostics was created in 2011 when Sekisui Medical

acquired Genzyme Diagnostics. The new company brings together

extensive product development capabilities and a broad global

sales/distribution network for our comprehensive product lines:

• Clinical chemistry systems and reagents

• Coagulation systems and reagents

• Infectious disease rapid tests, line immunoassays, and ELISA Kits

• Enzymes and specialty biochemicals

Sekisui Diagnostics is a diverse company with extensive product

development capabilities, state of the art manufacturing facilities,

and deep diagnostics expertise.

We are Sekisui Diagnostics and we are dedicated to improving the

lives of patients all around the world.

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CLINI-CAL

20 INF

ELISA/LINE ASSYS

Locations

Sekisui Diagnostics (UK) Ltd.Allington, Maidstone

Kent, UK

+44-1622-607800

Sekisui Virotech GmbHRüsselsheim, Germany

+49-6142-6909-0

Sekisui Diagnostics GmbHPfungstadt, Germany

+49-6157-990899

Sekisui Medical Co., Ltd.Tokyo, Japan

+81-3-3272-0671

Sekisui Medical Technology (China) Ltd.Shunyi District, Beijing, China

+86-10-8048-6325

Sekisui Medical Technology (China) Ltd.Chaoyang District, Beijing, China

+86-10-6269-2662

Worldwide HQSekisui Diagnostics, LLCLexington, MA, USA

+1 781-652-7800

Sekisui Diagnostics, LLCSan Diego, CA, USA

+1 858-777-2600

Sekisui Diagnostics, LLCExton, PA, USA

+1 610-594-8590

Sekisui Diagnostics, LLCStamford, CT, USA

+1 203-602-7777

Sekisui Diagnostics P.E.I. Inc.Charlottetown, PEI, Canada

+1 902-566-1396

80-8231-00-02 10/15

Other trademarks used here in are owned by their respective companies

OSOM® is a registered U.S. trademark of Sekisui Diagnostics, LLC.

©2015 Sekisui Diagnostics, LLC - All rights reserved

www.sekisuidiagnostics.com