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Product List VIROTECH Diagnostics GmbH Infectious Disease Diagnostics Serology – CSF – Stool

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Product ListVIROTECH Diagnostics GmbH

Infectious Disease DiagnosticsSerology – CSF – Stool

VIROTECH – An Overview

2016

2015

2014

2012

2011

2009

2008

2007

2004

2003

2001

2000

1997

1994

1993

1992

1988

1986Development of the Virotech system with standardized testing for all ELISA test kits in our portfolio

Beginning of distributing products of Alexon Trend, USA (later Remel, Oxoid and now ThermoFisher Scientific)

Start of distribution of MRL Diagnostics, USA products (today: Focus Diagnostics lnc.)

lntroduction of the first tests for CSF diagnostics - a product area that will be expanded in the following years

Expansion of the product portfolio with Westernblots by Biosens. Set-up and development of the new product line in order to become system diagnostics

Beginning of distribution of Meridian Bioscience, lnc. products

Entering contract manufacturing

Expansion of the distribution of Seramun Diagnostics GmbH‘s stool tests. In addition to that, infection diagnostics of Labsystems Diagnostics complements our portfolio

Expansion of the LINE product line - introduction of the Borrelia Europe LINE, Borrelia Europe LINE+ TpN17, Borrelia in vivo LINE to the European market

Entrance into PCR diagnostics. Beginning of the distribution of EuroClone Diagnostics s.r.l. products

lntroduction of the Pandemic New Influenza A ELISA and the Bordetella pertussis LINE with the innovative CatACT band

lntroduction of the Mycoplasma LINE - the only available LINE on the market until today

We expand our PCR test portfolio in the area of human genetics with the products of Asuragen, lnc.

Enigma Diagnostics Ltd. and Labsystems Diagnostics OY com-plement our product portfolio in the area of PCR diagnostics

Cooperation with the company Kapelan Bio-lmaging GmbH – the Lablmage® LA is available for evaluating our LINE lmmunoassays

Foundation of Virotech Systemdiagnostika GmbH

Establishment of our own antigen production site

Virotech becomes part of the Genzyme Diagnostics family which belongs to the biotechnology company Genzyme – we become Genzyme Virotech GmbH

Genzyme Diagnostics becomes part of Sekisui Medical in Japan and chan-ges its name to Sekisui Diagnostics. We become Sekisui Virotech GmbH

Since December 1st, 2016 VIROTECH Diagnostics GmbHAnniversary year

VIROTECH System Diagnostics ELISA .................................................................................6INFECTIOUSE DISEASE SEROLOGY

Human Diagnostic ELISA .................................................................................................................................... 6

Veterinary Diagnostic ELISA ............................................................................................................................... 9

Preabsorption of Rheumatoid Factors ...........................................................................................................9

Supplementary Material ELISA .......................................................................................................................10

Validation of ELISA Processors .......................................................................................................................10

Evaluation Software ELISA ...............................................................................................................................10

VIROTECH System Diagnostics LINE Immuno Assay ......................................................................................................................11INFECTIOUS DISEASE SEROLOGY

Human Diagnostic LINE ....................................................................................................................................11

Veterinary Diagnostic LINE ..............................................................................................................................13

Supplementary Material LINE .........................................................................................................................14

Interpretation Software LINE (human) - LabImage® LA ............................................................................14

Seramun Diagnostica ...................................................................................................................15INFECTIOUS DISEASE STOOL DIAGNOSTICS

Antigen Detection Tests – ELISA (sample material: stool samples / culture material) ......................15

Serazym® stool test controls as external controls for the Serazym® stool ELISAs ..............................16

Autoimmune Diagnostics – Line Immuno Assay ........................................................................................16

Content

Product Finder AAdenovirus

AB-ELISA / VIROTECH ............................... 6AG-ELISA / Seramun ......................... 15,16

AstrovirusAG-ELISA / Seramun ......................... 15,16

AutoimmunAB-Line / Seramun ................................. 16

BBordetella

AB-ELISA / VIROTECH ................................ 6Line / VIROTECH ...................................... 11

BorreliaAB-ELISA / VIROTECH ............................ 6,7CSF-ELISA / VIROTECH .......................... 6,7Line / VIROTECH ................................ 11,12CSF-Line / VIROTECH ....................... 11,12Veterinary ELISA / VIROTECH ................. 9Veterinary LINE / VIROTECH ................. 13

BrucellaAB-ELISA / VIROTECH ................................ 7

CCampylobacter

AG-ELISA / Seramun ......................... 15,16

Candida albicansAB-ELISA / VIROTECH ............................... 7

Clostridium difficile (Toxin/GDH)AG-ELISA / Seramun ......................... 15,16

CryptosporidiumAG-ELISA / Seramun ......................... 15,16

CytomegalievirusAB-ELISA / VIROTECH ................................ 7CSF-ELISA / VIROTECH .............................. 7

DDiphtheria

AB-ELISA / VIROTECH ................................ 7

EEntamoeba histolytica

AG-ELISA / Seramun ......................... 15,16

EnterovirusAB-ELISA / VIROTECH ............................... 7

Epstein Barr VirusAB-ELISA / VIROTECH ............................... 7CSF-ELISA / VIROTECH .............................. 7Line / VIROTECH ...................................... 12

External ControlsStool diagnostics ..................................... 16

FFSME / TBE

AB-ELISA / VIROTECH ............................... 8CSF-ELISA / VIROTECH ............................. 8

GGiardia lamblia

AG-ELISA / Seramun ......................... 15,16

HHelicobacter pylori

AB-ELISA / VIROTECH ............................... 8Line / VIROTECH ...................................... 12AG-ELISA / Seramun ......................... 15,16

Herpes simplex VirusLine / VIROTECH ...................................... 13

Herpes simplex Virus 1AB-ELISA spez. (gG1) / VIROTECH ......... 8CSF-ELISA / VIROTECH ............................. 8

Herpes simplex Virus 2AB-ELISA spez. (gG2) / VIROTECH ......... 8CSF-ELISA / VIROTECH ............................. 8

Herpes simplex Virus ScreenAB-ELISA / VIROTECH ............................... 8CSF-ELISA / VIROTECH ............................. 8

IInfluenza A

AB-ELISA / VIROTECH ............................... 8

Influenza BAB-ELISA / VIROTECH ............................... 8

MMeasles

AB-ELISA / VIROTECH ............................... 8CSF-ELISA / VIROTECH ............................. 8

Mumps AB-ELISA / VIROTECH ............................... 8CSF-ELISA / VIROTECH ............................. 8

Mycoplasma pneumoniaeAB-ELISA / VIROTECH ............................... 8Line / VIROTECH ...................................... 13

NNorovirus

AG-ELISA / Seramun ......................... 15,16

PParainfluenza

AB-ELISA / VIROTECH ............................... 8

Pertussis ToxinAB-ELISA / VIROTECH ................................ 6

PreabsorptionELISA / VIROTECH ..................................... 9

RRespiratory syncytial Virus

AB-ELISA / VIROTECH ............................... 9

RotavirusAG-ELISA / Seramun ......................... 15,16

RubellaCSF-ELISA / VIROTECH ............................. 9

SShiga Toxin

AG-ELISA / Seramun ......................... 15,16

Software VIROTECHSoftware ELISA......................................... 10Software LINE .......................................... 14

TFSME / TBE

AB-ELISA / VIROTECH ............................... 8CSF-ELISA / VIROTECH ............................. 8

TetanusAB-ELISA / VIROTECH ............................... 9

Treponema pallidumLine / VIROTECH ...................................... 13

VValidation Kit

ELISA / VIROTECH ................................... 10

Varizella zoster VirusAB-ELISA / VIROTECH ............................... 9CSF-ELISA / VIROTECH ............................. 9

YYersinia

AB-ELISA / VIROTECH ............................... 9Line / VIROTECH ...................................... 13

AB = Antibody, AG = Antigen

6

VIROTECH System Diagnostics ELISA

VIROTECH System Diagnostics ELISA

VIROTECH ELISA SystemThe VIROTECH ELISA product portfolio offers a wide range of qualitative, semi-quantitative and quantitative serological test systems for the most relevant infectious diseases. They serve as tools in order to diagnose specific IgG, IgM and IgA antibodies in human serum.

Furthermore, the VIROTECH system ensures a high level of flexibility by offering the possibility to apply dilution buffer, washing buffer, TMB, citrate stop solution as well as conjugates for all parameters.

In addition to serology, VIROTECH ELISAs can be used for detecting pathogen-specific antibodies in CSF within the established system. The index determination of antibodies follows the Reiber system. VIROTECH also offers antibody index controls for ensuring quality control of the daily CSF routine diagnostics.

INFECTIOUSE DISEASE SEROLOGYProduct Format Order Number Description

Human Diagnostic ELISA

Adenovirus ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC121.00

EC121.08

Can be processed in one run with all other kits of the respiratory panel.

Bordetella pertussis ELISAIgG / IgA Testkit 96 wells EC115.00 Sensitive Screening due to use of combined

antigens PT and FHA.

Pertussis Toxin ELISAIgA Testkit

IgG Testkit

IgG Quantification-Set

IgM Testkit

96 wells

96 wells

3 x 2 ml

96 wells

EC215A00

EC215G00

EN215Q60

EC215M00

Highly specific and sensitive diagnostics due to use of pure Pertussis Toxin. Quantitative IgG detection in IU/ml (WHO-Std) by using the IgG quantification set.

Borrelia afzelii + VlsE IgG ELISAIgG Testkit

IgG CSF Standards

IgG Antibody-Index-Control

96 wells

4 x 1 ml

4 x 1 ml

EC022G00

EC022L60

EN022L65

Maximum diagnostic sensitivity and good specificity due to an antigen mix of B. afzelii strain PKo, B. garinii strain PBr and B. burgdorferi ZS7 strain ZS7.

Borrelia afzelii + VIsE IgG Europe ELISAIgG Testkit

IgG CSF Standards

IgG Antibody-Index-Control

96 wells

4 x 1 ml

4 x 1 ml

EC024G00

EC022L60

EN022L65

Increased specificity due to a special cut-off adjustment.

7

VIROTECH System Diagnostics ELISA

Product Format Order Number Description

Borrelia afzelii IgM ELISAIgM Testkit

IgM CSF Standards

96 wells

4 x 1 ml

EC022M00

EC022L80

High sensitivity due a strong expressing OspC-B. afzelii-strain Pko.

Borrelia VlsE IgG ELISAIgG Testkit 96 wells EC023G00 High-specific Screening Assay, coated solely

with the in vivo expressed antigen VlsE.

Brucella ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC101.00

EC101.08

Detect B. abortas, B. melitensis and B. suis.

Candida albicans ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC111.00

EC111.08

Adjusted to primarily detect acute infections in IgG.

CMV ELISAIgG / IgM Testkit

IgG CSF Standards

96 wells

4 x 1 ml

EC113.00

EC113L60

Mix of native and recombinant antigens.

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

vaccination success. Aligned with WHO standards for quantitative detection in IU/ml.

EBV ELISAIgG / IgM Testkit

IgG CSF Standards

IgG Antibody-Index-Control

96 wells

4 x 1 ml

4 x 1 ml

EC102.00

EC102L60

EN102L65

EBV screening ELISA. A diagnostic statement with regard to seronegativity, suspicion to an EBV primary infection or past EBV infection can be made when combining the two antibody classes.

EBV EA-D ELISAIgG Testkit 96 wells EC202.00 “Early Antigen-Diffuse” belongs to the early

antigens, which are synthesised in the viral replication cycle (acute phase of infection).

EBV EBNA1 ELISAIgG Testkit 96 wells EC204.00 In case of a positive EBNA1-IgG und VCA-

IgM result, the "Diagnostic Factor" is used to make a clear distinction between primary and past infection (see VCA IgM ELISA).

EBV VCA IgG ELISAIgG Testkit 96 wells EC205G00 Includes the important high specific markers

for EBV: gp125 and p18.

EBV VCA IgM ELISAIgM Testkit 96 wells EC203M00 In case of a positive EBNA1-IgG und VCA-

IgM result, the "Diagnostic Factor" is used to make a clear distinction between primary and past infection (see EBNA1 ELISA).

Enterovirus ELISAIgA Testkit

IgG Testkit

IgM Testkit

96 wells

96 wells

96 wells

EC116A00

EC116G00

EC116M00

Coxackievirus B5 and Echovirus 14. Screening assay for the detection of heterotypic IgG-, IgA-, IgM-antibodies.

8

VIROTECH System Diagnostics ELISA

Product Format Order Number Description

Helicobacter pylori ELISAIgA Testkit

IgG Testkit

96 wells

96 wells

EC143A00

EC143G00

Sensitive detection of specific IgG- and IgA-antibodies.

HSV 1 (gG1) ELISAIgG / IgM Testkit

IgG CSF Standards

96 wells

4 x 1 ml

EC130.00

EC130L60

High-specific recombinant glycoprotein gG1.

HSV 2 (gG2) ELISAIgG / IgM Testkit

IgG CSF Standards

96 wells

4 x 1 ml

EC131.00

EC131L60

High-specific affinity-purified glycoprotein gG2.

HSV Screen ELISAIgG / IgM Testkit

IgG CSF Standards

IgG Antibody-Index-Control

96 wells

4 x 1 ml

4 x 1 ml

EC108.00

EC108L60

EN108L65

Screening of IgG and IgM of HSV1 and HSV2 in one assay.

Influenza A ELISAIgG / IgM Testkit

IgA Testkit

96 wells

96 wells

EC118.00

EC118A00

With seasonal updated antigens.

Influenza B ELISAIgG / IgM Testkit

IgA Testkit

96 wells

96 wells

EC119.00

EC119A00

With seasonal updated antigens.

Measles ELISAIgG Testkit

IgG CSF Standards

IgG Antibody-Index-Control

IgM Testkit

IgM CSF Standards

96 wells

4 x 1 ml

4 x 1 ml

96 wells

4 x 1 ml

EC105G00

EC105L60

EN105L65

EC105M00

EC105L80

Complete package of serum and CSF diagnostic.

Mumps ELISAIgG / IgM Testkit

IgG CSF Standards

96 wells

4 x 1 ml

EC106.00

EC106L60

Complete package of serum and CSF diagnostic.

Mycoplasma pneumoniae ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC114.00

EC114.08

Cut-off adjustment to detect acute infections in IgG. Specific infants cut-off adjustment.

Mycoplasma pn. polyvalent ELISAIgG, IgA+M Testkit 96 wells EC214.00 Efficient diagnostic due to simultaneous

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

ParaScreen ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC148.00

EC148.08

Detects Parainfluenza 1-3 in one test run.

9

VIROTECH System Diagnostics ELISA

Product Format Order Number Description

RSV ELISAIgG / IgM Testkit

IgA Set

96 wells

3 x 1.3 ml & 1 x 11 ml

EC107.00

EC107.08

Can be processed in one run with all other kits of the respiratory panel.

Rubella Virus CSF ELISAIgG CSF Testkit

IgG CSF Standards

IgG Antibody-Index-Control

96 wells

4 x 1 ml

4 x 1 ml

EC109L00

EC109L60

EN109L65

CSF Diagnostic for the detection of IgG antibody’s.

FSME / TBE ELISAIgG / IgM Testkit

IgG CSF Standard

IgG Antibody-Index-Control

IgM CSF Standards

96 wells

4 x 1 ml

4 x 1 ml

4 x 1 ml

EC117.00

EC117L60

EN117L65

EC117L80

Sensitive detection of an acute or recent infection with Tick-Borne-Encephalitis-Virus (TBE) or for the detection of vaccination antibodies.

Tetanus ELISAIgG Testkit 96 wells EC124.00 Survey of vaccination status and vaccination

success, routinely aligned with WHO stan-dards for quantitative detection in IU/ml.

VZV ELISAIgG / IgM Testkit

IgA Set

IgA CSF Standards

IgG CSF Standards

IgG Antibody-Index-Control

IgM CSF Standards

96 wells

3 x 1.3 ml & 1 x 11 ml

4 x 1 ml

4 x 1 ml

4 x 1 ml

4 x 1 ml

EC110.00

EC110.08

EC110L40

EC110L60

EN110L65

EC110L80

IgG adjusted as recommended by the Robert-Koch-Institute (aligned to the WHO standard: > 100IU/l = seropositive titer).

Yersinia enterocolitica ELISAIgG / IgA Testkit 96 wells EC142.00 Mix of purified native antigens and

recombinant antigens YopD, YopB & YopE.

Veterinary Diagnostic ELISA

Borrelia burgdorferi IgG Veterinary ELISAIgG Testkit dog / horse

IgM Set dog

96 wells

1 x 1.3 ml & 1 x 11 ml

DC122.00

DC122K80

Sensitive IgG antibody screening of dog or horse serum. Additional IgM diagnostics can be performed with the IgM kit for dogs.

Preabsorption of Rheumatoid FactorsRF-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 & dilution buffer

B/300.00 Rheumatoid factor absorbent for all IgM and IgA+M ELISA tests and Pertussis Toxin IgA ELISA.

10

VIROTECH System Diagnostics ELISA

Product Format Order Number Description

Supplementary Material ELISATetramethylbenzidine – Substrate Solution

11 ml 151101 General ELISA component

PBS-Washing Solution (20x concen-trated)

50 ml 141201 General ELISA component

Citrate-Stopping Solution 6 ml 141101 General ELISA component

PBS-Dilution Buffer (ready to use) 50 ml 141301 General ELISA component

VZV-IgM-Dilution Buffer (ready to use) 50 ml 141401 General ELISA component

IgA Conjugate (anti-human) 11 ml 131301 General ELISA component

IgA Conjugate 2 (anti-human) 11 ml 131601 General ELISA component

IgG Conjugate (anti-human) 11 ml 131101 General ELISA component

IgG Conjugate (anti-dog) 11 ml DC122.31

IgG Conjugate (anti-horse) 11 ml DC122.33

IgM Conjugate (anti-dog) 11 ml DC122.80

IgM Conjugate (anti-human) 11 ml 131201 General ELISA component

IgA + IgM Conjugate (anti-human) 11 ml 131401

12 breakable microtiter strips (antigen-coated)

1 plate ECXXXX01EC116M02DC122.01

Antigen-coated Enterovirus control antigen Borrelia burgdorferi Veterinary

IgA Set 3 x 1.3 ml & 1 x 11 ml ECXXX.08 IgA Controls and IgA Conjugate

IgA Controls 3 x 1.3 ml ENXXXK40 General ELISA component, filling level 3 x 2 ml by Enterovirus

IgG Controls 3 x 1.3 ml ENXXXK60 General ELISA component, filling level 3 x 2 ml by Enterovirus

IgM Controls 3 x 1.3 ml ENXXXK80 General ELISA component, filling level 3 x 2 ml by Enterovirus

IgG Standard Control Set 8 x 2 ml EN129K60 For use with the VIROTECH Diagnostics Diphtheria ELISA

IgG Standard Control Set 8 x 2 ml EN124K60 For use with the VIROTECH Diagnostics Tetanus ELISA

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

automated.

Pipetting Control-Set 2.8 ml

2 x 50 ml PBS-Dilution Buffer

EN250K60 Set to verify the pipetting process of ELISA devices (semi- or fully automated). For use with EC250.00.

Evaluation Software ELISALabCheck CSF Analysis 1x EX-CSF-GB Evaluation software for CSF diagnostics.

LabCheck 1-Point Quantification 1x EX-1-Punkt Evaluation software for 1-Point quantification for the VIROTECH Diagnostics Diphtheria, Pertussis Toxin and Tetanus IgG ELISA.

LabCheck Validation Kit and Pipetting Control-Set

1x EX-250-GB Evaluation software for the VIROTECH Validation Kit and Pipetting Control-Set.

11

VIROTECH System Diagnostics LINE Immuno Assay

VIROTECH System Diagnostics LINE Immuno Assay

VIROTECH LINE SystemVIROTECH LINE Immunoblots serve the qualitative detection of pathogen-specific IgG, IgM and IgA antibodies in human serum. The coated nitrocellulose test strips enable a high degree of flexibility by covering various system components. Microdispension of antigens at defined positions on the nitrocellulose ensures high reproducibility.

In diagnostics of Borrelia, exclusion bands contribute to a safe serology of IgG and IgM. In addition to that, the VIROTECH Borrelia LINE Immunoblots can be used for detecting antibodies in CSF.

Easy reading and interpretation of VIROTECH LINE Immunoblots can be done visually as well as by utilizing a user-friendly evaluation software.

INFECTIOUS DISEASE SEROLOGYProduct Format Order Number Description

Human Diagnostic LINE

B. pertussis + CatACT LINEIgA Line Immunoblot

IgA Line Immunoblot

IgG Line Immunoblot

IgG Line Immunoblot

IgA cut off Control*

IgA positive Control

IgG cut off Control*

IgG positive Control

IgG / IgA negative control

32 strips

96 strips

32 strips

96 strips

0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

WE116A32

WE116A96

WE116G32

WE116G96

WE116C40

WE116P40

WE116C60

WE116P60

WE116N20

New marker CatACT allows differentiation between vaccination and infection. Note towards parapertussis possible.

Controls separately available.

Borrelia LINEIgG Line ImmunoblotIgG Line Immunoblot

IgM Line ImmunoblotIgM Line Immunoblot IgG cut off Control*IgG positive Control

IgM cut off Control*IgM positive ControlIgG / IgM negative Control

32 strips96 strips

32 strips96 strips 0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

WE222G32WE222G96

WE222M32WE222M96

WE222C60WE222P60WE222C80WE222P80WE222N10

Excellent specificity and sensitivity due to the optimised combination of the most important common antigens (OspC, p39, p83/100) with well-known „in-vivo“ antigens. EBV-band as exclusion marker in IgM diagnostics.

Validated for CSF testing.

Controls separately available.

* supplementary LINE material (included in the kit)

12

VIROTECH System Diagnostics LINE Immuno Assay

Product Format Order Number Description

Borrelia in vivo LINE plusIgG Line ImmunoblotIgG Line Immunoblot IgG cut off control*IgG positive controlIgG negative control

32 strips96 strips

0.5 ml

0.5 ml

0.5 ml

WE223G32WE223G96

WE223C60WE223P60WE223N60

Treponema-band (TpN17) as exclusion marker in IgG diagnostics.

Validated for CSF testing.

Controls separately available.

Borrelia Europe LINEIgG Line ImmunoblotIgG Line Immunoblot

IgM Line ImmunoblotIgM Line Immunoblot IgG cut off control*IgG positive controlIgM cut off control*IgM positive controlIgG / IgM negative control

32 strips96 strips

32 strips96 strips 0.5 ml0.5 ml0.5 ml0.5 ml0.5 ml

WE224G32WE224G96

WE224M32WE224M96

WE224C60WE224P60WE224C80WE224P80WE224N10

Optimised combination of high purified lysate antigens (OspC, DbpA-PKo) and recombinant antigens (VlsE, p83, p58, p39, DbpA-Mix). EBV-band as exclusion marker in IgM diagnostics.

Validated for CSF testing.

Controls separately available.

Borrelia Europe plus TpN17 LINEIgG Line ImmunoblotIgG Line Immunoblot

IgG cut off control*IgG positive controlIgG negative control

32 strips96 strips

0.5 ml0.5 ml0.5 ml

WE225G32WE225G96

WE225C60WE225P60WE225N60

Treponema-band (TpN17) as exclusion marker in IgG diagnostics.

Validated for CSF testing.

Controls separately available.

EBV LINEIgG Line ImmunoblotIgG Line Immunoblot

IgM Line ImmunoblotIgM Line Immunoblot IgG cut off control*IgG positive control

IgM cut off control*IgM positive controlIgG / IgM control

32 strips96 strips

32 strips96 strips 0.5 ml0.5 ml0.5 ml0.5 ml0.5 ml

WE102G32WE102G96

WE102M32WE102M96

WE102C60WE102P60WE102C80WE102P80WE102N10

Double-cut-off strategy for EBNA1-inter-pretation. Tool for a clear differentiation between primary and past infection.

Controls separately available.

Helicobacter pylori LINEIgA Line Immunoblot

IgA Line Immunoblot

IgG Line Immunoblot

IgG Line Immunblot

IgA cut off control*

IgA positive control

IgG cut off control*

IgG positive control

IgG / IgA negative control

32 strips

96 strips

32 strips

96 strips

0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

WE243A32

WE243A96

WE243G32

WE243G96

WE243C40

WE243P40

WE243C60

WE243P60

WE243N20

Therapy-relevant differentiation of virulent and non-virulent strains via CagA and VacA.

Controls separately available.

* supplementary LINE material (included in the kit)

13

VIROTECH System Diagnostics LINE Immuno Assay

Product Format Order Number Description

HSV LINEIgG Line Immunoblot

IgG Line Immunoblot

IgG cut off control*

IgG positive control

IgG negative control

16 strips

32 strips

0.5 ml

0.5 ml

0.5 ml

WE130G16

WE130G32

WE130C60

WE130P60

WE130N60

High specific bands for HSV1 (gG1-recombi-nant) and HSV2 (gG2-purified) as well as a native total antigen band (1+2).

Controls separately available.

Mycoplasma pneumoniae LINEIgA Line Immunoblot

IgG Line Immunoblot IgM Line Immunoblot IgA cut off control*

IgA positive control

IgG cut off control*

IgG positive control

IgM cut off control

IgM positive control

IgG / IgA / IgM negative control

16 strips

16 strips 16 strips 0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

WE214A16

WE214G16

WE214M16

WE214C40

WE214P40

WE214C60

WE214P60

WE214C80

WE214P80

WE214N50

The only commercially available LINE, with an ideal combination of established (P1) & new antigens (P200, P400).

Controls separately available.

Treponema pallidum LINEIgG Line Immunoblot

IgG Line Immunoblot

IgM Line Immunoblot

IgM Line Immunoblot IgG cut off control*

IgG positive control

IgM cut off control*

IgM positive control

IgG / IgM negative control

16 strips

32 strips

16 strips

32 strips 0.5 ml

0.5 ml

0.5 ml

0.5 ml

0.5 ml

WE150G16

WE150G32

WE150M16

WE150M32

WE150C60

WE150P60

WE150C80

WE150P80

WE150N10

High sensitivity and specifity by using recombinant proteins.

Controls separately available.

Yersinia enterocolitica LINEIgA Line ImmunoblotIgA Line Immunoblot

IgG Line ImmunoblotIgG Line Immunoblot IgA cut off control*IgA positive controlIgG cut off control*IgG positive controlIgG / IgA negative control

32 strips96 strips

32 strips96 strips 0.5 ml0.5 ml0.5 ml0.5 ml0.5 ml

WE242A32WE242A96

WE242G32WE242G96

WE242C40WE242P40WE242C60WE242P60WE242N20

High sensitivity and specifity by using of recombinant proteins. Prevalence band YopDD in IgG shows contact with the pathogen.

Controls separately available.

Veterinary Diagnostic LINE

Borrelia Veterinary plus OspA LINEIgG Line Immunoblot (dog)

IgG Horse Set

32 strips

32 strips

DE226G32

DE226K62

Specific LINE assay to detect the most important Borrelia genospecies in dog and horse serum. Differentiation between infection and vaccination antibodies is possible for dogs.

* supplementary LINE material (included in the kit)

14

VIROTECH System Diagnostics LINE Immuno Assay

Product Format Order Number Description

Supplementary Material LINEIgA Conjugate (anti-human) 0.7 ml WE400.42 General LIA component 100x concentrated

IgG Conjugate (anti-human) 0.7 ml WE400.62 General LIA component, 100x concentrated

IgG Conjugate (anti-dog) 0.7 ml DE400.61 100x concentrated

IgG Conjugate (anti-horse) 0.7 ml DE400.62 100x concentrated

IgM Conjugate (anti-human) 0.7 ml WE400.82 General LIA component, 100x concentrated

Dilution- / Washbuffer 50 ml WE200.08 General LIA component, 10x concentrated

Substrate solution (BCIP/NBT) 57 ml WE200.02 General LIA component, ready to use

Incubationtray with 30 cavities, black, to be used with the ProfiBlot automates

1 x WE300.30S For processing with ProfiBlot device

Incubationtray with 48 cavities, black, to be used with the ProfiBlot automates

1 x WE300.48S For processing with ProfiBlot device

Incubationtray with 8 cavities 1 x WE300.08 Manual testing

Record Sheet, black 1 x WE300APB

Record Sheet lined 1 x WE301APB

LabImage® LA is a sophisticated software for efficient recognition and interpretation of the VIROTECH Diagnostics LINE Immunoblot. The complete automation of the strip analysis offers a maximum on standardisation, which significantly contributes to increase efficiency in medical diagnostic laboratories. Of course, bidirectional connection to LIS is possible. For a maximum on flexibility we provide the software in combination with different instruments depending on the size and automation of the laboratory (Examples of packages are listed below).

We would be glad to provide you with a tailored system for your laboratory.

Interpretation Software LINE (human) - LabImage® LA

LabImage® LA Package 1This package includes: LabImage® Reader with PC, LabImage® Soft-ware (CD), VIROTECH SetCards (CD), Manuals.

1 Package F/Lab-Image 1 Validated for VIROTECH Diagnostics LINE immunoblots.

LabImage® LA Package 2This package includes: LabImage® Reader without PC, LabImage® Software (CD), VIROTECH SetCards (CD), Manuals, License dongle.

1 Package F/Lab-Image 2 Validated for VIROTECH Diagnostics LINE immunoblots.

LabImage® LA Package 3This package includes: Flatbed Scanner (Plustek), LabImage® Software (CD), VIROTECH SetCards (CD), Manuals, License dongle.

1 Package F/Lab-Image 3 Validated for VIROTECH Diagnostics LINE immunoblots.

15

Seramun Diagnostica

Seramun Diagnostica

In 1992, the company Seramun Diagnostica GmbH was founded south of Berlin. Seramun mainly develops and produces products in order to diagnose pathogens with a focus on stool diagnostics. Serazym® Stool ELISA serve as a direct proof of antigens. Due to a consistent sample dilution and standardized test procedures, all Serazym® Stool ELISAs can be processed either automatically or manually. As a special service, Seramun offers „external quality controls“ for stool diagnostics twice a year.

In the realm of autoimmune diagnostics, Seramun Diagnostica GmbH has developed a panel of LINE Immunoassays: the Seraline® products. Evaluation of Seraline® strips can be processed either automatically with the Seraline® scan software or visually.

INFECTIOUS DISEASE STOOL DIAGNOSTICSProduct / Format Order Number Features

Antigen Detection Tests – ELISA (sample material: stool samples / culture material)

Serazym® Campylobacter96 wells2 x 96 wells

HW/E-093HW/E-093-A2

Specific detection of Campylobacter jejuni and Campylobacter coli in stool and culture samples.

Serazym® Clostridium difficile GDH96 wells2 x 96 wells

HW/E-107HW/E-107-A2

Sensitive screening for the detection of Glutamatdehydrogenase of Clostridium difficile.

Serazym® Clostridium difficile Toxin A + B96 wells2 x 96 wells

HW/E-040HW/E-040-A2

Sensitive detection with a biotin/streptavidin conjugate system of Toxin A & B in stool and culture samples.

Serazym® Verotoxin 1 + 296 wells2 x 96 wells

HW/E-030HW/E-030-A2

Sensitive detection with a biotin/streptavidin conjugate system of Verotoxin 1 & 2 (Shiga Toxin 1 & 2) in stool and culture samples.

Serazym® H. pylori 2nd Gen.96 wells HW/E-114-A Sensitive detection of Helicobacter pylori with monoclonal antibodies.

Serazym® Adenovirus96 wells2 x 96 wells

HW/E-017HW/E-017-A2

Detection of the capsid protein hexon, common to all human pathogenic Adenovirus serotypes.

Serazym® Astrovirus96 wells2 x 96 wells

HW/E-045HW/E-045-A2

Detection of Astrovirus specific antigens in a short incubation time of 60-10 min.

Serazym® Norovirus96 wells2 x 96 wells

HW/E-061HW/E-061-A2

Detection of Norovirus capsid proteins of the genogroups GGI and GGII.

Serazym® Rotavirus96 wells2 x 96 wells

HW/E-020HW/E-020-A2

Detection of the major protein VP-6 of group A Rotaviruses.

Serazym® Cryptosporidium parvum96 wells HW/E-039-A Sensitive detection with monoclonal antibodies.

Serazym® Entamoeba histolytica96 wells HW/E-018-A Sensitive detection of Entamoeba histolytica.

Serazym® Giardia96 wells HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1) despite intermittent

excretion.

16

Seramun Diagnostica

Serazym® Stool test controls are tools for external quality controls for ELISA stool diagnostics of infectious pathogens. Two stool test controls are offered as a set with 400µl each per test parameter in a stabilized stool suspension. Shipping of the sets is offered twice a year on previously fixed dates. The dates are announced by VIROTECH Diagnostics GmbH. After the expiration date the qualitative results (positive or negative) will be announced on our website.

Product / Format Order Number Features

Serazym® Stool test controls as external controls for the Serazym® stool ELISAs

Serazym® Stool test control Campylobacter2 x 400µl HW/EK-093 controls with unknown result, twice a year.

Serazym® Stool test control Clostridium difficile GDH2 x 400µl HW/EK-107 controls with unknown result, twice a year.

Serazym® Stool test control C. difficile Toxin A+B2 x 400µl HW/EK-040 controls with unknown result, twice a year.

Serazym® Stool test control Verotoxin 1+22 x 400µl HW/EK-030 controls with unknown result, twice a year.

Serazym® Stool test control H. pylori 2nd Gen.2 x 400µl HW/EK-114 controls with unknown result, twice a year.

Serazym® Stool test control Adenovirus2 x 400µl HW/EK-017 controls with unknown result, twice a year.

Serazym® Stool test control Astrovirus2 x 400µl HW/EK-045 controls with unknown result, twice a year.

Serazym® Stool test control Norovirus2 x 400µl HW/EK-061 controls with unknown result, twice a year.

Serazym® Stool test control Rotavirus2 x 400µl HW/EK-020 controls with unknown result, twice a year.

Serazym® Stool test control Cryptosporidium parvum2 x 400µl HW/EK-039 controls with unknown result, twice a year.

Serazym® Stool test control Entamoeba histolytica2 x 400µl HW/EK-018 controls with unknown result, twice a year.

Serazym® Stool test control Giardia2 x 400µl HW/EK-106 controls with unknown result, twice a year.

Autoimmune Diagnostics – Line Immuno Assay

Seraline® Zöliakie-3 IgG20 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 IgA20 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 IgG20 strips HW/LIA-002-12G Line Immunoassay for detection of IgG-antibodies in connective tissue

diseases in human serum or plasma.

Seraline® Vaskulitis-3 IgG20 strips HW/LIA-003-3G Line Immunoassay for detection of IgG-antibodies in systemic vasculitis in

human serum or plasma.

Seraline® HepAk-7 IgG20 strips HW/LIA-004-7G Line Immunoassay for detection of IgG-autoantibodies in autoimmune liver

diseases in human serum or plasma.

Notes

Notes

We supply our products worldwide and have collaborations with more than 30 distributors. We are constantly looking for new distributors to expand our distributor network.

Interested? Please contact us!

VIROTECH – International

Michael Becker

International Sales [email protected]

Dominic Drozd

Order Processing [email protected]

You are already Distributor and need support?

Product Information / Product Management:[email protected]

Product Safety / Support:[email protected]

VIROTECH Diagnostics GmbH

Löwenplatz 565428 Rüsselsheim

[email protected]

Product List VIROTECH Diagnostics GmbH, V1/2017e used pictures oficially purchased at Fotolia, LLC

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CO2 compensated print. Supports the project LifeStraw® drinking water purification, Kenia.