Product List Infectious Disease Diagnostics Serology CSF Stool

Transcription

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

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3 VIROTECH An Overview Since December 1st, 2016 VIROTECH Diagnostics GmbH Anniversary year Cooperation with the company Kapelan Bio-lmaging GmbH the Lablmage LA is available for evaluating our LINE lmmunoassays Enigma Diagnostics Ltd. and Labsystems Diagnostics OY complement our product portfolio in the area of PCR diagnostics Genzyme Diagnostics becomes part of Sekisui Medical in Japan and changes its name to Sekisui Diagnostics. We become Sekisui Virotech GmbH We expand our PCR test portfolio in the area of human genetics with the products of Asuragen, lnc. lntroduction of the Mycoplasma LINE - the only available LINE on the market until today lntroduction of the Pandemic New Influenza A ELISA and the Bordetella pertussis LINE with the innovative CatACT band 2008 Entrance into PCR diagnostics. Beginning of the distribution of EuroClone Diagnostics s.r.l. products Expansion of the LINE product line - introduction of the Borrelia Europe LINE, Borrelia Europe LINE+ TpN17, Borrelia in vivo LINE to the European market Expansion of the distribution of Seramun Diagnostics GmbH s stool tests. In addition to that, infection diagnostics of Labsystems Diagnostics complements our portfolio 2003 Entering contract manufacturing 2001 Beginning of distribution of Meridian Bioscience, lnc. products 2000 Expansion of the product portfolio with Westernblots by Biosens. Set-up and development of the new product line in order to become system diagnostics 1997 lntroduction of the first tests for CSF diagnostics - a product area that will be expanded in the following years Virotech becomes part of the Genzyme Diagnostics family which belongs to the biotechnology company Genzyme we become Genzyme Virotech GmbH Start of distribution of MRL Diagnostics, USA products (today: Focus Diagnostics lnc.) Beginning of distributing products of Alexon Trend, USA (later Remel, Oxoid and now ThermoFisher Scientific) 1988 Establishment of our own antigen production site Foundation of Virotech Systemdiagnostika GmbH 1986 Development of the Virotech system with standardized testing for all ELISA test kits in our portfolio

4 Content VIROTECH System Diagnostics ELISA...6 INFECTIOUSE 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...11 INFECTIOUS DISEASE SEROLOGY Human Diagnostic LINE...11 Veterinary Diagnostic LINE...13 Supplementary Material LINE...14 Interpretation Software LINE (human) - LabImage LA...14 Seramun Diagnostica...15 INFECTIOUS 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

5 Product Finder A Adenovirus AB-ELISA / VIROTECH... 6 Astrovirus Autoimmun AB-Line / Seramun B Bordetella AB-ELISA / VIROTECH... 6 Line / VIROTECH Borrelia AB-ELISA / VIROTECH... 6,7 CSF-ELISA / VIROTECH... 6,7 Line / VIROTECH... 11,12 CSF-Line / VIROTECH... 11,12 Veterinary ELISA / VIROTECH... 9 Veterinary LINE / VIROTECH Brucella AB-ELISA / VIROTECH... 7 C Campylobacter Candida albicans AB-ELISA / VIROTECH... 7 Clostridium difficile (Toxin/GDH) Cryptosporidium Cytomegalievirus AB-ELISA / VIROTECH... 7 CSF-ELISA / VIROTECH... 7 D Diphtheria AB-ELISA / VIROTECH... 7 E Entamoeba histolytica Enterovirus AB-ELISA / VIROTECH... 7 Epstein Barr Virus AB-ELISA / VIROTECH... 7 CSF-ELISA / VIROTECH... 7 Line / VIROTECH External Controls Stool diagnostics F FSME / TBE AB-ELISA / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 G Giardia lamblia H Helicobacter pylori AB-ELISA / VIROTECH... 8 Line / VIROTECH Herpes simplex Virus Line / VIROTECH Herpes simplex Virus 1 AB-ELISA spez. (gg1) / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 Herpes simplex Virus 2 AB-ELISA spez. (gg2) / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 Herpes simplex Virus Screen AB-ELISA / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 I Influenza A AB-ELISA / VIROTECH... 8 Influenza B AB-ELISA / VIROTECH... 8 M Measles AB-ELISA / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 Mumps AB-ELISA / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 Mycoplasma pneumoniae AB-ELISA / VIROTECH... 8 Line / VIROTECH N Norovirus P Parainfluenza AB-ELISA / VIROTECH... 8 Pertussis Toxin AB-ELISA / VIROTECH... 6 Preabsorption ELISA / VIROTECH... 9 R Respiratory syncytial Virus AB-ELISA / VIROTECH... 9 Rotavirus Rubella CSF-ELISA / VIROTECH... 9 S Shiga Toxin Software VIROTECH Software ELISA Software LINE T FSME / TBE AB-ELISA / VIROTECH... 8 CSF-ELISA / VIROTECH... 8 Tetanus AB-ELISA / VIROTECH... 9 Treponema pallidum Line / VIROTECH V Validation Kit ELISA / VIROTECH Varizella zoster Virus AB-ELISA / VIROTECH... 9 CSF-ELISA / VIROTECH... 9 Y Yersinia AB-ELISA / VIROTECH... 9 Line / VIROTECH AB = Antibody, AG = Antigen

6 VIROTECH System Diagnostics ELISA VIROTECH System Diagnostics ELISA VIROTECH ELISA System The 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 SEROLOGY Product Format Order Number Description Human Diagnostic ELISA Adenovirus ELISA IgA Set 3 x 1.3 ml & 1 x 11 ml EC EC Can be processed in one run with all other kits of the respiratory panel. Bordetella pertussis ELISA IgG / IgA Testkit EC Sensitive Screening due to use of combined antigens PT and FHA. Pertussis Toxin ELISA IgA Testkit IgG Testkit IgG Quantification-Set 3 x 2 ml EC215A00 EC215G00 EN215Q60 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. IgM Testkit EC215M00 Borrelia afzelii + VlsE IgG ELISA IgG Testkit IgG Antibody-Index-Control 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 ELISA IgG Testkit EC024G00 EC022L60 Increased specificity due to a special cut-off adjustment. IgG Antibody-Index-Control EN022L65 6

7 VIROTECH System Diagnostics ELISA Product Format Order Number Description Borrelia afzelii IgM ELISA IgM Testkit IgM CSF Standards EC022M00 EC022L80 High sensitivity due a strong expressing OspC-B. afzelii-strain Pko. Borrelia VlsE IgG ELISA IgG Testkit EC023G00 High-specific Screening Assay, coated solely with the in vivo expressed antigen VlsE. Brucella ELISA IgA Set 3 x 1.3 ml & 1 x 11 ml EC EC Detect B. abortas, B. melitensis and B. suis. Candida albicans ELISA IgA Set 3 x 1.3 ml & 1 x 11 ml EC EC Adjusted to primarily detect acute infections in IgG. CMV ELISA EC Mix of native and recombinant antigens. EC113L60 Diphtheria ELISA IgG Testkit EC Usable for survey of vaccination status and vaccination success. Aligned with WHO standards for quantitative detection in IU/ml. EBV ELISA IgG Antibody-Index-Control EC 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 ELISA IgG Testkit EC Early Antigen-Diffuse belongs to the early antigens, which are synthesised in the viral replication cycle (acute phase of infection). EBV EBNA1 ELISA IgG Testkit EC 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 ELISA IgG Testkit EC205G00 Includes the important high specific markers for EBV: gp125 and p18. EBV VCA IgM ELISA IgM Testkit 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 ELISA IgA Testkit IgG Testkit IgM Testkit EC116A00 EC116G00 EC116M00 Coxackievirus B5 and Echovirus 14. Screening assay for the detection of heterotypic IgG-, IgA-, IgM-antibodies. 7

8 VIROTECH System Diagnostics ELISA Product Format Order Number Description Helicobacter pylori ELISA IgA Testkit IgG Testkit EC143A00 EC143G00 Sensitive detection of specific IgG- and IgA-antibodies. HSV 1 (gg1) ELISA EC High-specific recombinant glycoprotein gg1. EC130L60 HSV 2 (gg2) ELISA EC EC131L60 High-specific affinity-purified glycoprotein gg2. HSV Screen ELISA EC EC108L60 Screening of IgG and IgM of HSV1 and HSV2 in one assay. IgG Antibody-Index-Control EN108L65 Influenza A ELISA EC With seasonal updated antigens. IgA Testkit EC118A00 Influenza B ELISA EC With seasonal updated antigens. IgA Testkit EC119A00 Measles ELISA IgG Testkit EC105G00 EC105L60 Complete package of serum and CSF diagnostic. IgG Antibody-Index-Control EN105L65 IgM Testkit EC105M00 IgM CSF Standards EC105L80 Mumps ELISA EC EC106L60 Complete package of serum and CSF diagnostic. Mycoplasma pneumoniae ELISA IgA Set 3 x 1.3 ml & 1 x 11 ml EC EC Cut-off adjustment to detect acute infections in IgG. Specific infants cut-off adjustment. Mycoplasma pn. polyvalent ELISA IgG, IgA+M Testkit EC 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 ELISA EC Detects Parainfluenza 1-3 in one test run. IgA Set 3 x 1.3 ml & 1 x 11 ml EC

9 VIROTECH System Diagnostics ELISA Product Format Order Number Description RSV ELISA IgA Set 3 x 1.3 ml & 1 x 11 ml EC EC Can be processed in one run with all other kits of the respiratory panel. Rubella Virus CSF ELISA IgG CSF Testkit EC109L00 EC109L60 CSF Diagnostic for the detection of IgG antibody s. IgG Antibody-Index-Control EN109L65 FSME / TBE ELISA IgG CSF Standard IgG Antibody-Index-Control EC EC117L60 EN117L65 Sensitive detection of an acute or recent infection with Tick-Borne-Encephalitis-Virus (TBE) or for the detection of vaccination antibodies. IgM CSF Standards EC117L80 Tetanus ELISA IgG Testkit EC Survey of vaccination status and vaccination success, routinely aligned with WHO standards for quantitative detection in IU/ml. VZV ELISA IgA Set IgA CSF Standards 3 x 1.3 ml & 1 x 11 ml EC EC EC110L40 IgG adjusted as recommended by the Robert-Koch-Institute (aligned to the WHO standard: > 100IU/l = seropositive titer). EC110L60 IgG Antibody-Index-Control EN110L65 IgM CSF Standards EC110L80 Yersinia enterocolitica ELISA IgG / IgA Testkit EC Mix of purified native antigens and recombinant antigens YopD, YopB & YopE. Veterinary Diagnostic ELISA Borrelia burgdorferi IgG Veterinary ELISA IgG Testkit dog / horse IgM Set dog 1 x 1.3 ml & 1 x 11 ml Preabsorption of Rheumatoid Factors DC DC122K80 Sensitive IgG antibody screening of dog or horse serum. Additional IgM diagnostics can be performed with the IgM kit for dogs. RF-SorboTech Vial - 2 ml Rheumatoid factor absorbent for all IgM and IgA+M ELISA tests and Pertussis Toxin IgA ELISA. RF-SorboTech Vial - 10 ml 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/ Rheumatoid factor absorbent for all IgM and IgA+M ELISA tests and Pertussis Toxin IgA ELISA. 9

10 VIROTECH System Diagnostics ELISA Product Format Order Number Description Supplementary Material ELISA Tetramethylbenzidine Substrate Solution PBS-Washing Solution (20x concentrated) 11 ml General ELISA component 50 ml General ELISA component Citrate-Stopping Solution 6 ml General ELISA component PBS-Dilution Buffer (ready to use) 50 ml General ELISA component VZV-IgM-Dilution Buffer (ready to use) 50 ml General ELISA component IgA Conjugate (anti-human) 11 ml General ELISA component IgA Conjugate 2 (anti-human) 11 ml General ELISA component IgG Conjugate (anti-human) 11 ml General ELISA component IgG Conjugate (anti-dog) 11 ml DC IgG Conjugate (anti-horse) 11 ml DC IgM Conjugate (anti-dog) 11 ml DC IgM Conjugate (anti-human) 11 ml General ELISA component IgA + IgM Conjugate (anti-human) 11 ml breakable microtiter strips (antigen-coated) 1 plate ECXXXX01 EC116M02 DC 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 Processors Validation Kit, ELISA EC 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 EC Evaluation Software ELISA LabCheck 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. 10

11 VIROTECH System Diagnostics LINE Immuno Assay VIROTECH System Diagnostics LINE Immuno Assay VIROTECH LINE System VIROTECH 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 SEROLOGY Product Format Order Number Description Human Diagnostic LINE B. pertussis + CatACT LINE IgA Line Immunoblot IgA Line Immunoblot WE116A32 WE116A96 New marker CatACT allows differentiation between vaccination and infection. Note towards parapertussis possible. WE116G32 WE116G96 IgA cut off Control* WE116C40 IgA positive Control WE116P40 IgG cut off Control* WE116C60 IgG positive Control WE116P60 IgG / IgA negative control WE116N20 Borrelia LINE IgM Line Immunoblot IgM Line Immunoblot WE222G32 WE222G96 WE222M32 WE222M96 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. IgG cut off Control* IgG positive Control IgM cut off Control* IgM positive Control IgG / IgM negative Control WE222C60 WE222P60 WE222C80 WE222P80 WE222N10 Validated for CSF testing. * supplementary LINE material (included in the kit) 11

12 VIROTECH System Diagnostics LINE Immuno Assay Product Format Order Number Description Borrelia in vivo LINE plus IgG cut off control* IgG positive control IgG negative control WE223G32 WE223G96 WE223C60 WE223P60 WE223N60 Treponema-band (TpN17) as exclusion marker in IgG diagnostics. Validated for CSF testing. Borrelia Europe LINE IgM Line Immunoblot IgM Line Immunoblot IgG cut off control* IgG positive control IgM cut off control* IgM positive control IgG / IgM negative control WE224G32 WE224G96 WE224M32 WE224M96 WE224C60 WE224P60 WE224C80 WE224P80 WE224N10 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. Borrelia Europe plus TpN17 LINE IgG cut off control* IgG positive control IgG negative control WE225G32 WE225G96 WE225C60 WE225P60 WE225N60 Treponema-band (TpN17) as exclusion marker in IgG diagnostics. Validated for CSF testing. EBV LINE WE102G32 WE102G96 Double-cut-off strategy for EBNA1-interpretation. Tool for a clear differentiation between primary and past infection. IgM Line Immunoblot IgM Line Immunoblot WE102M32 WE102M96 IgG cut off control* IgG positive control IgM cut off control* IgM positive control IgG / IgM control WE102C60 WE102P60 WE102C80 WE102P80 WE102N10 Helicobacter pylori LINE IgA Line Immunoblot IgA Line Immunoblot WE243A32 WE243A96 Therapy-relevant differentiation of virulent and non-virulent strains via CagA and VacA. WE243G32 IgG Line Immunblot WE243G96 IgA cut off control* WE243C40 IgA positive control WE243P40 IgG cut off control* WE243C60 IgG positive control WE243P60 IgG / IgA negative control WE243N20 * supplementary LINE material (included in the kit) 12

13 VIROTECH System Diagnostics LINE Immuno Assay Product Format Order Number Description HSV LINE 16 strips WE130G16 WE130G32 High specific bands for HSV1 (gg1-recombinant) and HSV2 (gg2-purified) as well as a native total antigen band (1+2). IgG cut off control* WE130C60 IgG positive control WE130P60 IgG negative control WE130N60 Mycoplasma pneumoniae LINE IgA Line Immunoblot IgM Line Immunoblot 16 strips 16 strips 16 strips WE214A16 WE214G16 WE214M16 The only commercially available LINE, with an ideal combination of established (P1) & new antigens (P200, P400). IgA cut off control* WE214C40 IgA positive control WE214P40 IgG cut off control* WE214C60 IgG positive control WE214P60 IgM cut off control WE214C80 IgM positive control WE214P80 IgG / IgA / IgM negative control WE214N50 Treponema pallidum LINE IgM Line Immunoblot 16 strips 16 strips WE150G16 WE150G32 WE150M16 High sensitivity and specifity by using recombinant proteins. IgM Line Immunoblot WE150M32 IgG cut off control* WE150C60 IgG positive control WE150P60 IgM cut off control* WE150C80 IgM positive control WE150P80 IgG / IgM negative control WE150N10 Yersinia enterocolitica LINE IgA Line Immunoblot IgA Line Immunoblot WE242A32 WE242A96 WE242G32 WE242G96 High sensitivity and specifity by using of recombinant proteins. Prevalence band YopDD in IgG shows contact with the pathogen. IgA cut off control* IgA positive control IgG cut off control* IgG positive control IgG / IgA negative control WE242C40 WE242P40 WE242C60 WE242P60 WE242N20 Veterinary Diagnostic LINE Borrelia Veterinary plus OspA LINE (dog) IgG Horse Set * supplementary LINE material (included in the kit) 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. 13

14 VIROTECH System Diagnostics LINE Immuno Assay Product Format Order Number Description Supplementary Material LINE IgA Conjugate (anti-human) 0.7 ml WE General LIA component 100x concentrated IgG Conjugate (anti-human) 0.7 ml WE General LIA component, 100x concentrated IgG Conjugate (anti-dog) 0.7 ml DE x concentrated IgG Conjugate (anti-horse) 0.7 ml DE x concentrated IgM Conjugate (anti-human) 0.7 ml WE General LIA component, 100x concentrated Dilution- / Washbuffer 50 ml WE General LIA component, 10x concentrated Substrate solution (BCIP/NBT) 57 ml WE General LIA component, ready to use Incubationtray with 30 cavities, black, to be used with the ProfiBlot automates Incubationtray with 48 cavities, black, to be used with the ProfiBlot automates 1 x WE300.30S For processing with ProfiBlot device 1 x WE300.48S For processing with ProfiBlot device Incubationtray with 8 cavities 1 x WE 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 1 This package includes: LabImage Reader with PC, LabImage Software (CD), VIROTECH SetCards (CD), Manuals. LabImage LA Package 2 This package includes: LabImage Reader without PC, LabImage Software (CD), VIROTECH SetCards (CD), Manuals, License dongle. LabImage LA Package 3 This package includes: Flatbed Scanner (Plustek), LabImage Software (CD), VIROTECH SetCards (CD), Manuals, License dongle. 1 Package F/Lab-Image 1 Validated for VIROTECH Diagnostics LINE immunoblots. 1 Package F/Lab-Image 2 Validated for VIROTECH Diagnostics LINE immunoblots. 1 Package F/Lab-Image 3 Validated for VIROTECH Diagnostics LINE immunoblots. 14

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 DIAGNOSTICS Product / Format Order Number Features Antigen Detection Tests ELISA (sample material: stool samples / culture material) Serazym Campylobacter 2 x HW/E-093 HW/E-093-A2 Specific detection of Campylobacter jejuni and Campylobacter coli in stool and culture samples. Serazym Clostridium difficile GDH 2 x HW/E-107 HW/E-107-A2 Sensitive screening for the detection of Glutamatdehydrogenase of Clostridium difficile. Serazym Clostridium difficile Toxin A + B 2 x Serazym Verotoxin x HW/E-040 HW/E-040-A2 HW/E-030 HW/E-030-A2 Sensitive detection with a biotin/streptavidin conjugate system of Toxin A & B in stool and culture samples. 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. HW/E-114-A Sensitive detection of Helicobacter pylori with monoclonal antibodies. Serazym Adenovirus 2 x HW/E-017 HW/E-017-A2 Detection of the capsid protein hexon, common to all human pathogenic Adenovirus serotypes. Serazym Astrovirus 2 x HW/E-045 HW/E-045-A2 Detection of Astrovirus specific antigens in a short incubation time of min. Serazym Norovirus HW/E-061 Detection of Norovirus capsid proteins of the genogroups GGI and GGII. 2 x HW/E-061-A2 Serazym Rotavirus 2 x HW/E-020 HW/E-020-A2 Detection of the major protein VP-6 of group A Rotaviruses. Serazym Cryptosporidium parvum HW/E-039-A Sensitive detection with monoclonal antibodies. Serazym Entamoeba histolytica HW/E-018-A Sensitive detection of Entamoeba histolytica. Serazym Giardia HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1) despite intermittent excretion. 15

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 Campylobacter 2 x 400µl HW/EK-093 controls with unknown result, twice a year. Serazym Stool test control Clostridium difficile GDH 2 x 400µl HW/EK-107 controls with unknown result, twice a year. Serazym Stool test control C. difficile Toxin A+B 2 x 400µl HW/EK-040 controls with unknown result, twice a year. Serazym Stool test control Verotoxin 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 Adenovirus 2 x 400µl HW/EK-017 controls with unknown result, twice a year. Serazym Stool test control Astrovirus 2 x 400µl HW/EK-045 controls with unknown result, twice a year. Serazym Stool test control Norovirus 2 x 400µl HW/EK-061 controls with unknown result, twice a year. Serazym Stool test control Rotavirus 2 x 400µl HW/EK-020 controls with unknown result, twice a year. Serazym Stool test control Cryptosporidium parvum 2 x 400µl HW/EK-039 controls with unknown result, twice a year. Serazym Stool test control Entamoeba histolytica 2 x 400µl HW/EK-018 controls with unknown result, twice a year. Serazym Stool test control Giardia 2 x 400µl HW/EK-106 controls with unknown result, twice a year. Autoimmune Diagnostics Line Immuno Assay 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 G 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. 16

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19 VIROTECH International 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! Michael Becker International Sales Director Dominic Drozd Order Processing International You are already Distributor and need support? Product Information / Product Management: info@virotechdiagnostics.com Product Safety / Support: qualitymanagement@virotechdiagnostics.com

20 VIROTECH Diagnostics GmbH Löwenplatz Rüsselsheim info@virotechdiagnostics.com CO2 compensated print. Supports the project LifeStraw drinking water purification, Kenia. Product List VIROTECH Diagnostics GmbH, V1/2017e used pictures oficially purchased at Fotolia, LLC