/ P r o d u c t C a t a l o g I N F E C T I OD U. 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

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1 / P r o d u c t C a t a l o g I N F E C T I O U S I N F E C T I OD U IS SDE I SA E AS S E 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

2 INFECTIOUS DISEASE Sekisui Diagnostics Sekisui Diagnostics is a recognized leader in the development, manufacture, and supply of infectious disease assays to the IVD industry. The Virotech product line consists of over 120 infectious disease assays and automated solutions to simplify your laboratory experience. The OSOM family of rapid diagnostics offers you a variety of family and women's health products and our services deliver unparalleled value. Fast, point-of-care results may help reduce follow-up visits, promote education/prevention and allow for more precise treatment. rapid diagnostics TABLE OF CONTENTS OSOM Rapid Diagnostics OSOM Point-of-Care Rapid Tests Woman s Health OSOM Point-of-Care Rapid Tests Family Health Infectious Disease The Virotech ELISA System The Virotech LINE System Seramun Stool ELISA INF 1

3 OSOM RAPID DIAGNOSTICS OSOM POINT-OF-CARE RAPID TESTS / WOMEN S HEALTH OSOM POINT-OF-CARE RAPID TESTS / FAMILY HEALTH OSOM BVBLUE Test To aid in the diagnosis of Bacterial Vaginosis Detects elevated vaginal fluid sialidase activity Sensitivity 92.8% vs Grams stain Fast, objective results OSOM hcg Urine Test One-step simple; dip and read 25 mlu/ml sensitivity Two-color results OSOM Ultra Strep A Test Sensitivity not statistically different than single swab culture* Two-color results in 5 minutes Includes 2 extra tests for QC OSOM Strep A Test 96% sensitivity; 98% specificity Fits easily into a busy practice Two-color results in 5 minutes Includes 2 extra tests for QC OSOM Mono Test Aids in the diagnosis of infectious mononucleosis >99% sensitivity; 96% specificity Two-color results in 5 minutes Includes 2 extra tests for QC OSOM Trichomonas Rapid Test The only CLIA-waived rapid test available More sensitive than wet mount Two-color results in 10 minutes Detects antigen; does not require live organisms OSOM Card Pregnancy and hcg Combo Test Increased sensitivity: 10 mlu/ml serum; 20 mlu/ml urine Easy to read black lines Results in 3 minutes OSOM Influenza A&B Test Differentiates between Flu A&B Results in 10 minutes Nasal swab specimens Includes 2 extra tests for QC OSOM H. pylori Test 95.9% sensitivity; 89% specificity Results in 10 minutes Sample types: serum, plasma or whole blood No drop counting pipette * Refer to package insert for details ORDERING INFORMATION CONFIGURATION CATALOG NUMBER OSOM BVBlue Test 25 Tests 183 BVBlue Control Kit 184 OSOM hcg URINE Test 50 Tests 101 hcg Urine Control Set 134 OSOM Trichomonas Rapid Test 25 Tests 181 or 181E (CE marked) Trichomonas Positive Control Kit 182 (CE marked) OSOM Card Pregnancy Test 25 Tests 102 hcg URINE Control Set 134 OSOM hcg Combo Test 25 Tests 124 hcg Serum Control Set 138 ORDERING INFORMATION CONFIGURATION CATALOG NUMBER OSOM Ultra Strep A Test 25 Tests Tests 149 OSOM Strep A Test 50 Tests 141 or 141E (CE marked) OSOM Atrep A Test 25 Tests 141E-20 (CE marked) OSOM Mono Test 25 Tests 145 (CE marked) OSOM Influenza A&B Test 25 Tests 190 or 190E (CE marked) Influenza A&B Control Kit 191 (CE marked) OSOM H. Pylori Test 25 Tests 175 (CE marked) 2 INF INF 3

4 ELISA ASSAYS CLINICAL CHEMISTRY REAGENTS Infectious Disease THE VIROTECH ELISA SYSTEM 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 guidelines 98/79/EG. 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 INFECTIOUS DISEASE SEROLOGY / ELISA Adenovirus ELISA IgG / IgM Testkit 96 wells EC Can be processed in one run with all other kits IgA-Set Set EC of the respiratory panel Bordetella pertussis ELISA IgG / IgA Testkit 96 wells EC 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 3x 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 AI-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 AI-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 IgM AI-Control 4 x 1 ml EN022L85 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 DC Sensitive IgG antibody screening of dog or IgM Set dog Set DC122K80 horse serum Brucella ELISA IgG / IgM Testkit 96 wells EC Detects Brucella abortus, Brucella IgA-Set Set EC melitensis and Brucella suis Candida albicans ELISA IgG / IgM Testkit 96 wells EC Adjusted to primarily detect acute IgA-Set Set EC infections in IgG Cytomegalo Virus ELISA IgG / IgM Testkit 96 wells EC Very sensitive mix of native and IgG CSF-Standards Standards EC113L60 recombinant antigens Diphtheria ELISA IgG Testkit 96 wells EC 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 EC EBV screening ELISA IgG CSF-Standards Standards EC102L60 A diagnostic statement with regard to IgG AI-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 EC Early Antigen-Diffuse belongs to the early antigens, which are synthesised in the viral replication cycle (acute phase of infection) 4 INF INF 5

5 ELISA ASSAYS INFECTIOUS DISEASE SEROLOGY / ELISA EBV EBNA 1 ELISA IgG Testkit 96 wells EC 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 marker 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 EC High-specific recombinant glycoprotein gg1 IgG CSF-Standards Standards EC130L60 HSV 2 (gg2) ELISA IgG / IgM Testkit 96 wells EC High-specific affinity-purified glycoprotein gg2 IgG CSF-Standards Standards EC131L60 HSV Screen ELISA IgG / IgM Testkit 96 wells EC Screening of IgG and IgM of HSV 1and HSV 2 IgG CSF-Standards Standards EC108L60 in one assay IgA CSF-Standards Standards EC108L40 IgG AI-Control 4 x 1 ml EN108L65 IgG AI-Control 4 x 1 ml EN108L45 Influenza A ELISA IgG / IgM Testkit 96 wells EC Up to date antigens as per seasonal IgA Testkit 96 wells EC118A00 recommendation of the WHO Influenza B ELISA IgG / IgM Testkit 96 wells EC 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 AI-Controls 1 x 4 ml EN105L65 Mumps ELISA IgG / IgM Testkit 96 wells EC Complete package of serum and IgG CSF-Standards Standards EC106L60 CSF diagnostic Mycoplasma pneumoniae ELISA IgG / IgM Testkit 96 wells EC Cut-off adjustment to detect acute infections IgA-Set Set EC in IgG. Specific infants cut-off adjustment. INFECTIOUS DISEASE SEROLOGY / ELISA ParaScreen ELISA IgG / IgM Testkit 96 wells EC Detects Parainfluenza 1-3 in one test run IgA-Set Set EC RSV ELISA IgG / IgM Testkit 96 wells EC Can be processed in one run with all other kits IgA-Set Set EC of the respiratory panel Rubella ELISA IgG CSF-Kit 96 wells EC109L00 CSF Diagnostic for IgG, AI-Controls for IgG IgG CSF-Standards Standards EC109L60 IgG AI-Control 4 x 1 ml EN109L65 TBE ELISA IgG / IgM Testkit 96 wells EC117.00L00 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 AI-Control 4 x 1 ml EN117L65 Tetanus ELISA IgG Testkit 96 wells EC 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 EC IgG adjusted as recommended by the IgA-Set Set EC Robert-Koch-Institute (aligned to the WHO IgG CSF-Standards Standards EC110L60 standard: > 100IU/l = seropositive titer) IgM CSF-Standards Standards EC110L80 IgA CSF-Standards Standards EC110L40 IgG AI-Control 4 x 1 ml EN110L65 Yersinia enterocolitica ELISA IgG / IgA Testkit 96 wells EC Mix of purified native antigens and recombinant antigens YopD, YopB & YopE INFECTIOUS DISEASE SEROLOGY / ELISA PREABSORPTION OF RHEUMATOID FACTORS 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, B/ 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/ Rheumatoid factor absorbent for all IgM and 40 tubes with IgA+M ELISA tests and Pertussis Toxin IgA ELISA 450 μl dilution buffer each Mycoplasma pn. polyvalent ELISA IgG/IgA+M Testkit 96 wells 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. 6 INF INF 7

6 ELISA ASSAYS INFECTIOUS DISEASE SEROLOGY / ELISA SINGLE COMPONENTS FOR HUMAN SEROLOGY EIA VALIDATION OF ELISA PROCESSORS PRODUCT FORMAT ORDER NUMBER Tetramethylbenzidine Substrate Solution 11 ml PBS-Washing Solution (20x concentrated) 50 ml Citrate-Stopping Solution 6 ml Validation Kit, ELISA 96 wells EC 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 EC PBS-Dilutionbuffer (blue, ready to use) 50 ml VZV-IgM-Dilutionbuffer (green, ready to use) 50 ml IgA-Conjugate (anti-human) 11 ml IgA-Conjugate 2 (anti-human) 11 ml IgA+M Conjugate 11mL IgG-Conjugate (anti-human) 11 ml IgM-Conjugate (anti-human) 11 ml 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 Standards Tetanus ELISA Set EN124K60 IgG Standards 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. VIROTECH ELISA ASSAYS - PACKAGE CONTENTS Semiquantitative ELISA-Testkits, ECXXX 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-, IgMor IgG-antibodies in Cerebrospinal Fluid. ENXXXL65, ENXXXL45 AI-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 8 INF INF 9

7 LINE ASSAYS CLINICAL CHEMISTRY REAGENTS Infectious Disease THE VIROTECH LINE SYSTEM The Virotech Line Immuno Assays (LINE) 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 INFECTIOUS DISEASE SEROLOGY LINE Bordetella pertussis + CatACT LINE IgG Line Immunoblot 32 strips WE116G32 New marker CatACT allows differentiation between IgG Line Immunoblot 96 strips WE116G96 vaccination and infection. Note towards IgG cut off control 0,5 ml WE116C60 parapertussis possible. IgG positive control 0,5 ml WE116P60 IgA Line Immunoblot 32 strips WE116A32 IgA Line Immunoblot 96 strips WE116A96 IgA cut off control 0,5 ml WE116C40 IgA positive control 0,5 ml WE116P40 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 IgM Line Immunoblot WE222M32 EBV-band as exclusion marker in IgM diagnostics. IgM Line Immunoblot IgM Line Immunoblot 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 WE225P60 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 10 INF INF 11

8 LINE ASSAYS INFECTIOUS DISEASE SEROLOGY LINE Helicobacter pylori LINE IgG Line Immunoblot 32 strips WE243G32 Therapy-relevant differentiation of virulent and IgG Line Immunoblot 96 strips WE243G96 non-virulent strains via CagA and VacA IgG cut off control 0,5 ml WE243C60 IgG positive control 0,5 ml WE243P60 IgA Line Immunoblot 32 strips WE243A32 IgA Line Immunoblot 96 strips WE243A96 IgA cut off control 0,5 ml WE243C40 IgA positive control 0,5 ml WE243P40 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.) IgG Line Immunoblot 16 strips WE214G16 The only commercially available LINE, with IgG cut off control 0,5 ml WE214C60 an ideal combination of established IgG positive control 0,5 ml WE214P60 (P1) & new antigens (P200, P400) IgA Line Immunoblot 16 strips WE214A16 IgA cut off control 0,5 ml WE214C40 IgA positive control 0,5 ml WE214P40 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 INFECTIOUS DISEASE SEROLOGY LINE SINGLE COMPONENTS FOR LINE TEST KITS PRODUCT FORMAT ORDER NUMBER IgG-conjugate (anti-human, 100x concentrated) 0,7 ml WE IgM-conjugate (anti-human, 100x concentrated) 0,7 ml WE IgA-conjugate (anti-human, 100x concentrated) 0,7 ml WE Dilution- / Washbuffer (10x concentrated) 50 ml WE Substrate Solution (BCIP/NBT, ready to use) 57 ml WE Incubationtray with 42 cavities, to be used with the Apollo automates 1 pcs WE 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 WE Blotrix Record Sheet 1 booklet WE301APB INFECTIOUS DISEASE SEROLOGY LINE DOG KIT (BASIS KIT) WITH ADDITIONAL HORSE SET Borrelia Europe plus TpN17 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 Yersinia enterocolitica LINE (recomb.) IgG Line Immunoblot 32 strips WE242G32 Prevalence band YopDD in IgG shows IgG Line Immunoblot 96 strips WE242G96 contact with the pathogen IgG cut off control 0,5 ml WE242C60 IgG positive control 0,5 ml WE242P60 IgA Line Immunoblot 32 strips WE242A32 IgA Line Immunoblot 96 strips WE242A96 IgA cut off control 0,5 ml WE242C40 IgA positive control 0,5 ml WE242P40 IgM Line Immunoblot 32 strips WE242M32 IgM cut off control 0,5 ml WE242C80 IgM positive control 0,5 ml WE242P80 IgG/IgA/IgM negative control 0,5 ml WE242N50 12 INF INF 13

9 ELISA ASSAYS CLINICAL CHEMISTRY REAGENTS Seramun Stool ELISA 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 ANTIGEN DETECTION TESTS ELISA (TEST MATERIAL: HUMAN STOOL SAMPLES / CULTURE MATERIAL) BACTERIA 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 wells HW/E-030 Sensitive detection with a biotin/streptavidin Serazym Verotoxin x 96 wells HW/E-030-A2 conjugate system of Verotoxin 1 & 2 (Shiga Toxin 1 & 2) in stool and culture samples 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 VIRUSES FORMAT ORDER NUMBER FEATURES 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 min Serazym Norovirus 96 wells HW/E-061 Detection of Norovirus capsid proteins Serazym Norovirus 2 x 96 wellst 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 PARASITES FORMAT ORDER NUMBER FEATURES 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 ( >10 5 ml) Serazym Giardia lamblia 96 wells HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1) despite intermittent excretion 14 INF INF 15

10 NOTES 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. 16 INF

11 Locations Worldwide HQ Sekisui Diagnostics, LLC Lexington, MA, USA Sekisui Diagnostics, LLC San Diego, CA, USA Sekisui Diagnostics, LLC Exton, PA, USA Sekisui Diagnostics, LLC Stamford, CT, USA Sekisui Diagnostics P.E.I. Inc. Charlottetown, PEI, Canada Sekisui Diagnostics (UK) Ltd. Kings Hill, West Malling Kent, UK Sekisui Virotech GmbH Rüsselsheim, Germany American Diagnostica GmbH Pfungstadt, Germany Sekisui Medical Co., Ltd. Tokyo, Japan Sekisui Medical Technology (China) Ltd. Shunyi District, Beijing, China Sekisui Medical Technology (China) Ltd. Chaoyang District, Beijing, China Other trademarks used here in are owned by their respective companies 2014 Sekisui Diagnostics, LLC - All rights reserved /14