+++ neu +++ new +++ neu HIGHLIGHTS 2018

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1 ++ neu +++ new +++ n HIGHLIGHTS 2018

2 MIKROGEN BASED IN MUNICH, GERMANY

3 Product Overview PRODUCT OVERVIEW Bacterial infections Anaplasma / Ehrlichia Adenovirus Babesia Astrovirus Bordetella Chikungunya Virus Borrelia + Neuroborreliosis Cytomegalo Virus (CMV) + Avidity Brucella Dengue Campylobacter Enterovirus Chlamydia Epstein-Barr Virus (EBV) + Avidity Coxiella burnetii (Phase 1, 2) Hantavirus CXCL13 Hepatitis C Virus (HCV) Diphtheria (Corynebact. diphtheriae) Hepatitis E Virus (HEV) Helicobacter pylori Herpes simplex Virus (HSV-1, -2, -1/2) Legionella (HIV-1, -2) Leptospira Human Papillomavirus (HPV) MRSA Mycobacterium tuberculosis complex Measles Mycoplasma pneumoniae Mumps Streptococcus Group B Norovirus Tetanus (Tetanus toxoid) Treponema pallidum Parvovirus B19 + Avidity Yersinia Respiratory Syncytialvirus (RSV) Autoimmune diseases Parasitic infections Rotavirus ANA Screen Ascaris lumbricoides ANA Screen Rubella Virus CENP (Centromer proteins) Echinococcus CENP (Centromer proteins) dsdna (Doublestranded DNA) Entamoeba histolytica dsdna (Doublestranded DNA) Sapovirus Histon Leishmania Histon TBE Jo-1 (Aminoacyl-tRNA Synthetase) Shistosoma mansoni Jo-1 (Aminoacyl-tRNA Synthetase) La (SS-B) Taenia solium La (SS-B) Yellow Fever Virus PCNA Toxocara canis PCNA Rib-P (Ribosomal P) Toxoplasma gondii + Avidity Rib-P (Ribosomal P) * Parasitic Luminex available infections only the EU RNP 68 Trichinella spiralis RNP 68 Ascaris lumbricoides RNPA RNPA Echinococcus RNPC RNPC Entamoeba histolytica Ro52 (SS-A) / TRIM21 Multi parameter Ro52 (SS-A) / TRIM21 Leishmania Ro60 Your (SS-A) Partner of Choice for Innovative Solutions HFRS / HPS Ro60 (SS-A) in the Clinical Laboratory Shistosoma mansoni MIKROGEN GmbH Floriansbogen Neuried Germany Phone: Fax: mikrogen@mikrogen.de Scl-70 (Topoisomerase I) TORCH Complex Scl-70 (Topoisomerase I) Taenia solium SmB Tropical Fever SmB Toxocara canis ** SmD HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome SmD Toxoplasma gondii + Avidity Automation Trichinella spiralis Candida Fungal infections Equipment solutions Candida Multi Software parameter solutions Equipment solutions HFRS / HPS ** Software solutions TORCH Molecular Complex Diagnostics Tropical DNA & Fever RNA Extraction DNA & RNA Extraction ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome PCR Positive Controls PCR Positive Controls Product Overview Autoimmune diseases Fungal infections Automation Molecular Diagnostics Strip assay ELISA Luminex * PCR Strip assay Strip assay ELISA ELISA Luminex Luminex * PCR PCR Viral infections * Luminex available only in the EU Strip assay ELISA Luminex * PCR Strip assay Strip assay ELISA ELISA Luminex Luminex * PCR PCR

4 recomscan 4.0 Software for the automatic analysis and interpretation of MIKROGEN test strips. Product advantages Automatic analysis of recomline test strips Fast and simple handling Reproducible band analysis Interpretation of complex band patterns Extensive control and expedient correction options Histogram view Permanent storage of test strip images, easy data retrieval Meaningful reports in different detail variants Database for patient history, quality control and research Optional standardised data exchange with laboratory information system Prevention of reading and transmission errors Import of worklist Detailed export of analysis data

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6 NEW Tropical Fever Complete Diagnostic Portfolio Singleplex amplicube Zika Virus Real-time RT-PCR for the detection of Zika virus (ZIKV) RNA Multiplex alphacube Tropical Fever 1 Real-time RT-PCR for the detection of Dengue, Zika, Chikungunya and Yellow Fever virus Multiplex recomline Tropical Fever First and unique serological assay for simultaneous detection and differentiation of Dengue, Chikungunya and Zika virus in one test strip Dengue Virus Chikungunya Virus React.-Contr. Conj.-Contr. Cutoff Contr. NS1 E E1 Zika Virus NS1 E

7 Differentiation of Dengue from Zika and primary from secondary infections Primary Dengue Primary Zika German resident German resident (DENV + DENV) (DENV + ZIKV) Colombian resident Colombian resident Chikungunya (Dengue non-endemic area) Chikungunya (Dengue endemic area) Italian resident Colombian resident Course of Infection IgG amplicube Zika Virus alphacube Tropical Fever 1 Virus RNA detection in serum and urine IgM Antibody recomline Tropical Fever acute phase convalescent phase

8 HIV HCV Syphilis Differentiation in one step React. Contr. IgG Contr. React. Contr. IgG Contr. React. Contr. Ig Contr. IgG IgM Cut-off Contr. Cut-off Contr. Cut-off Contr. gp105 gp36 p31 p24 p17 gp120 gp41 p51 recomline HIV-1 & HIV-2 IgG Core 1 Core 2 Helicase NS3 NS4 NS5 recomline HCV IgG Tp47 TmpA Tp257 (Gpd) Tp453 Tp17 Tp15 recomline Treponema IgG recomline Treponema IgM Same incubation time for all three assays Automated processing and interpretation Native, recombinant HIV / HCV / Treponema antigens

9 Sensitive detection of all four HEV genotypes occuring worldwide Increasing Numbers of Acute Hepatitis E

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11 Chlamydia Identify Infectious Infertility and Reduce Invasive Imaging recomline Chlamydia IgG recomline Chlamydia IgA [IgM] React.-Contr. Ig Contr. IgG IgA IgM Cutoff Contr. MOMP OMP2 TARP CPAF HSP60 MOMP OMP2 TARP CPAF YwbM MOMP OMP2 TARP CPAF Chlamydia trachomatis Chlamydia pneumoniae Chlamydia psittaci Reduced CT and CP cross-reactivities inconclusive Chlamydia screening results Diagnosis of fallopian tube infertility. Globally most frequently caused (~30%) by Chlamydia trachomatis recomwell Chlamydia trachomatis IgG, IgA Coming soon recomwell Chlamydia pneumoniae IgG, IgM, IgA

12 recomline TORCH Screening IgG recomline TORCH Screening IgM Strip-Immunoassay for the detection of IgG and IgM antibodies against Toxoplasma gondii, rubella virus, cytomegalovirus (CMV), and herpes simplex virus type 1 and 2 (HSV-1/2) For the determination of the immune status for Toxoplasma gondii, rubella virus, CMV, and HSV-1/2, whole cell lysate antigens are used in the IgG and IgM assays. recomline TORCH Screening IgG ning). Interpretation of the recomline TORCH Screening IgG test follows a two-band strategy. The major band (lysate antigen) shows the presence or the determination (see Table below). recomline TORCH Screening IgM The diagnostic information presented by the recomline TORCH Screening IgG assay is supported by the recomline TORCH Screening IgM assay. The test strips antibodies to T. gondii, rubella virus, CMV, and HSV type 1 and 2, respectively. Sensitivity of the T. gondii early phase antigen ROP1c. React. contr. IgG Conjugate contr. IgM Cut-off contr. Lysate T. gondii Lysate/ROP1c p30 Rubella CMV Ru-co Lysate Lysate gb2 Product Advantages The recomline TORCH Screening IgG and IgM is unique on the market allowing screening of 4 pathogens on one stripe as well as determination of the time of infection (CMV, T. gondii), protective or non-protective immune status (Rubella) IgG IgM and type differentiation (HSV-2) Fast and easy test procedure No automation necessary and especially suitable for small laboratories with low sample throughput Easy test procedure; automation possible Easy and objective evaluation and documentation by recomscan software Separate detection of IgG and IgM antibodies possible Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable CE label: The recomline TORCH Screening tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices recomline TORCH Screening IgG HSV Lysate gg2 Antigen Toxoplasma gondii lysate and recombinant antigen p30 CMV lysate and recombinant antigen gb2 Rubella lysate and vaccination band HSV-1/2 lysate and recombinant antigen gg2 for HSV-2 Characteristics Enables exclusion of a primary infection during the last 3 months if a positive reactivity is detectable for lysate and p30 Enables exclusion of a primary infection during the last 6 8 weeks if a positive reactivity is detectable for lysate and gb2 enables the assessment of protective or non-protective immunity. This band is adjusted according to the guidelines of the World Health Organization (WHO) and it nearly causative agent of genital herpes).

13 recomline Toxoplasma IgG [Avidity] recomline Toxoplasma IgM [IgA] Strip-Immunoassay with antigens produced by recombinant techniques for the detection of IgG, IgM and IgA antibodies against Toxoplasma gondii Toxoplasma gondii shows the highest incidence of any human pathogenic parasite in central Europe. As a rule, the course of the infection is asymptomatic or mild and confers lifelong immunity on immunocompetent persons. Initial contact with the pathogen during pregnancy can result in transmission of the pathogens to the foetus, resulting in severe damage to it. The main task of routine diagnostics is therefore a preventive testing before or during pregnancy. Due to the frequently sub clinical course and the mostly uncharacteristic clinical picture, a clinical diagnosis is impossible without laboratory tests and is mainly based on serological methods with its main interest to differentiate acute infections from past infections. It is well known of an acute toxoplasmosis. Much more of importance is to determine the The recomline Toxoplasma is worldwide the only test system which meets the requirements for the special diagnosis of toxoplasmosis especially for pregnancy. The optimized combination of using recombinant antigens for IgG market for the determination of the status of a Toxoplasma infection. Product advantages Recombinant antigens rsag1 Easy and clear interpretation due to easy to read bands Easy test procedure; automation possible Easy and objective evaluation and documentation by recomscan software Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable Separate detection of IgG, IgM and IgA antibodies possible Easy and reliable determination of avidity possible CE label: The recomline Toxoplasma tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices Most accurate determination of stage of infection Recombinant Toxoplasma antigens in use React. Contr. Conjugate Contr. IgG IgA IgM Cut-off Contr. ROP1c MIC3 GRA7 GRA8 p30 MAG1 GRA1 Antigen ROP1c MIC3 GRA7 GRA8 p30 MAG1 GRA1 rsag1 Origin Tachyzoite and bradyzoite antigen Tachyzoite antigen Tachyzoite and bradyzoite antigen Tachyzoite and bradyzoite antigen Tachyzoite antigen Tachyzoite antigen Tachyzoite and bradyzoite antigen Tachyzoite antigen

14 ELISA Infectious Diseases Your one-stop shop Bacterial infections IgG IgM IgA Bordetella pertussis IU/ml Borrelia + Neuroborreliosis Brucella Campylobacter Chlamydia Coxiella burnetii (Phase 1, 2) Diphtheria (C. dipht.) IU/ml Helicobacter pylori Legionella pneumophila Leptospira Mycoplasma Tetanus (Tetanustoxoid) Treponema pallidum Yersinia Fungal infections Candida Parasitic infections Ascaris lumbricoides Chagas (Trypanosoma cruzi) Echinococcus Entamoeba histolytica Leishmania Schistosoma mansoni Taenia solium Toxocara canis Toxoplasma gondii IU/ml Trichinella spiralis Viral infections IgG IgM IgA Adenovirus Chikungunya Virus Cytomegalie Virus (CMV) Dengue Epstein-Barr Virus (EBV) Hanta Virus Hepatitis E Virus (HEV) Herpes simplex Virus (HSV-1, -2, -1/2) Measles Mumps Parvovirus B19 Respiratory Syncytial Virus (RSV) Rubella Virus IU/ml Varizella Zoster Virus (VZV) Zika Virus Antigen detection Human Papillomavirus (HPV) Automation Equipment solutions Software solutions Dynex DSX

15 AUTOMATION OF STRIP ASSAYS With the test kits, the instruments for processing and the strip evaluation software recomscan, MIKROGEN offers a suitable master plan for the automation of your diagnostic laboratory. Complete automation of strip assays in one - from incubation to result. Dynablot Plus 1 instrument Instrument for the automatic processing of MIKROGEN test strips. Capacity: up to 44 strips. Dimensions 52.5 x 31 x 25 cm BLOTrix reader 1 instrument Scanner to scan test strips directly in the black incubation trays. Flat bed scanner 1 instrument Scanner to scan test strips from black evaluation sheets. recomscan 1 licence Software for the automatic detection and interpretation of MIKROGEN test strips (recomblot and recomline). Easy to connect to the laboratory EDP (electronic data processing), available as an option. recomscan-plugin Database 1 licence Software module: Database extension for recomscan for the administration of patient data. recomscan-plugin Import / Export 1 licence Software module: Extension for recomscan for data exchange with LIM. recomscan-plugin Patient Report 1 licence Software module: Extension for recomscan for print out of patient reports.

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17 recomline CMV ensured by the use of recombinant antigens Fast and easy to use due to automation and software based evaluation Reliable patient management assured by the use of which allow to determine the point of infection avidity determination enables to exclude infections <12 weeks

18 NEW Human Papillomavirus Groundbreaking HPV immunoassay A new era for cervical cancer diagnostics recomwell HPV 16/18/45 recomwell Keratin 5/8/18 Detection of oncoproteins format

19 oncoprotein detection HPV infection 7-30 years Degree of risk Normal Precancer / Dysplasia Cancer Infectious viral particles Squamous epithelium Cervical trans- Basal layer Basement membrane Dermis HPV DNA/RNA oncoprotein Overexpression of HPV oncoprotein during disease progression 2. recom Primary HPV screening HPV-PCR-test Result is positive for high risk HPV type 16 and/or 18 Result is positive for other high risk HPV types Use of recomwell HPV 16/18/45 Test Cytology ASC-US NILM Colposcopy Follow up in 6-12 months HPV-PCR negative Routine screening 3. Preparation of Patient Samples & Test Principle and Procedure A B Sample preparation. Before performing the recomwell HPV 16/18/45, the cervical smears (stored in ThinPrep PreservCyt Solution) are processed as follows: Centrifugation Incubation Transfer 15 ml sample material into a screw cap tube with conical bottom. Centrifuge for 15 minutes at 600g. Carefully remove excess supernatant. Add 500 µl lysis buffer A, vortex, and incubate for 30 minutes at room temperature. Add 500 µl lysis buffer B and vortex. Indirect sandwich test. the wells of a microtiter plate. 1 st Incubation Add prepared patient sample, and incubate for 1 hour at room temperature. wash 3 times 2 nd Incubation Add ready-to-use secondary anti-hpv antibody, and incubate for 1 hour at room temperature. wash 3 times 3 rd Incubation Add ready-to-use streptavidin conjugate, and incubate for 1 hour at room temperature. wash 6 times Color reaction Add ready-to-use TMB solution and incubate 30 minutes at room temperature. Stop the substrate solution with H 3 PO 4 and measure the absorbence at 450 nm. Turn around time: approx. 4h

20 Molecular Diagnostics Real-Time Single/Multiplex PCR Respiratory Infections Sexually Transmitted Diseases Gastrointestinal Infections Tick Borne Infections New New In Development Tropical Fever Veterinary Antimicrobial Resistance PCR DNA & RNA Extraction

21 PCR Positive Controls External run and process controls Monitor the complete analytical process from RNA/DNA Complete, non-infectious microorganisms in buffer Can be combined with every commercial or in-house PCR assay of Analysis indicating the expected Ct value and approx. 100 copies / µl Size: 4.8 ml (4 x 1.2 ml) CE label Viruses Article no Bacteria Article no Adenovirus PCR Control Cytomegalovirus PCR Control (RUO) Epstein Barr Virus PCR Control Enterovirus RT-PCR Control Herpes Simplex Virus Typ 1 PCR Control Herpes Simplex Virus Typ 2 PCR Control Bordetella parapertussis PCR Control Bordetella pertussis PCR Control Borrelia burgdorferi PCR Control Chlamydia pneumoniae PCR Control (RUO) Streptococcus agalactiae (GBS) PCR Control Mycobacterium tuberculosis complex (BCG) PCR Control Respiratory Syncytial Virus A RT-PCR Control Respiratory Syncytial Virus B RT-PCR Control Rotavirus RT-PCR Control TBE (Tick Borne Encephalitis Virus) RT-PCR Control PCR Control

22 NEW Connective Tissue Diseases (CTD) recomline ANA/ENA IgG ensured by the use of recombinant antigens Fast and easy to use due to automation and software based evaluation One single approach to differentiate between the most frequent autoimmune collagenose diseases enabled by the use of 15 different antigens Highly reliable diagnostic of SLE using subunits of Sm and RNP antigens and high Antinuclear antibodies - ANA Extractable nuclear Antigens - ENA CENPB Rib-P PCNA Histon dsdna React. Control IgG Control Cut-off Control RNP68 PNPA RNPC SmB SmD Ro/SSA60 Ro/SSA52 Rib-P CREST Calcinosis cutis-raynaud phe- lity-sclerodactyly-teleangiectasia-syndrome SLE Systemic lupus erythematosus PCNA Scl70 RNPA RNPC RNP68 SmB SmD Ro/SSA52 Ro/SSA60 SSB SCL70 Jo-1 Jo-1 Histon SLE Systemic lupus erythematosus MCTD Mixed connective tissue disease SLE Systemic lupus erythematosus Sjögren s Syndrom PSS Progressive systemic scleroderma Myositis dsdna

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24 new +++ neu +++ new + MIKROGEN GmbH Floriansbogen Neuried Germany Phone Fax mikrogen@mikrogen.de Distribuido por I N G E N I E R Í A B I O M É D I C A Sede principal: Cra. 46 No Piso 3 Celular: Whatsapp: Contacto: servicioalcliente@bmecolombia.com Bogotá, Colombia. FONEWSE008