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+++ neu +++ new +++ n HIGHLIGHTS – 2018

High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

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Page 1: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

+++ neu +++ new +++ neu

HIGHLIGHTS – 2018

Page 2: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

MIKROGEN – BASED IN MUNICH, GERMANY

Page 3: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

PRODUCT OVERVIEW

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Bacterial infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Anaplasma / Ehrlichia

Babesia

Bordetella

Borrelia + Neuroborreliosis

Brucella

Campylobacter

Chlamydia

Coxiella burnetii (Phase 1, 2)

CXCL13

Diphtheria (Corynebact. diphtheriae)

Helicobacter pylori

Legionella

Leptospira

MRSA

Mycobacterium tuberculosis complex

Mycoplasma pneumoniae

Streptococcus Group B

Tetanus (Tetanus toxoid)

Treponema pallidum

Yersinia

Viral infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Adenovirus

Astrovirus

Chikungunya Virus

Cytomegalo Virus (CMV) + Avidity

Dengue

Enterovirus

Epstein-Barr Virus (EBV) + Avidity

Hantavirus

Hepatitis C Virus (HCV)

Hepatitis E Virus (HEV)

Herpes simplex Virus (HSV-1, -2, -1/2)

(HIV-1, -2)

Human Papillomavirus (HPV)

Measles

Mumps

Norovirus

Parvovirus B19 + Avidity

Respiratory Syncytialvirus (RSV)

Rotavirus

Rubella Virus

Sapovirus

TBE

Yellow Fever Virus

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical Laboratory

Fungal infections

Candida

Autoimmune diseases Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

ANA Screen

CENP (Centromer proteins)

dsDNA (Doublestranded DNA)

Histon

Jo-1 (Aminoacyl-tRNA Synthetase)

La (SS-B)

PCNA

Rib-P (Ribosomal P)

RNP 68

RNPA

RNPC

Ro52 (SS-A) / TRIM21

Ro60 (SS-A)

Scl-70 (Topoisomerase I)

SmB

SmD ** HFRS = Hemorrhagic Fever Renal Syndrome, HPS = Hantavirus Pulmonary Syndrome

Multi parameterHFRS / HPS**

TORCH Complex

Tropical Fever

Parasitic infections Stri

p a

ssay

ELIS

A

Lum

inex

®*

PCR

Ascaris lumbricoides

Echinococcus

Entamoeba histolytica

Leishmania

Shistosoma mansoni

Taenia solium

Toxocara canis

Toxoplasma gondii + Avidity

Trichinella spiralis

Automation

Equipment solutions

Software solutions

Molecular Diagnostics

DNA & RNA Extraction

PCR Positive Controls

* Luminex® available only in the EU

Product Overview

MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Phone: +49 89 54801-0 | Fax: +49 89 54801-100 | [email protected] | www.mikrogen.de

Your Partner of Choice for Innovative Solutions in the Clinical LaboratoryPUeFlyerE037_2018-03

Page 4: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

Poster_recomScan_D03.indd 1 04.11.2010 13:43:26

recomScan 4.0Software for the automatic analysis and interpretation of MIKROGEN test strips.

Test strip analysis system

NEW

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

Page 5: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation
Page 6: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

Tropical FeverComplete Diagnostic Portfolio

Singleplex

Multiplex

Multiplex recomLine Tropical Fever

First and unique serological assay for simultaneous detection and differentiation of Dengue, Chikungunya and Zika virus in one test strip

alphaCube Tropical Fever 1

Real-time RT-PCR for the detection of Dengue, Zika, Chikungunya and Yellow Fever virus

ampliCube Zika Virus

Real-time RT-PCR for the detection of Zika virus (ZIKV) RNA

React.-Contr.

Conj.-Contr.Cutoff Contr.

NS1

E

E1

NS1

E

Dengue Virus

ChikungunyaVirus

ZikaVirus

NEW

Page 7: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

Primary DengueGermanresident

Primary ZikaGermanresident

(DENV + DENV) (DENV + ZIKV)

Colombianresident

Colombianresident

Article-No. Immunoblot

recomLine Tropical Fever IgG

recomLine Tropical Fever IgM

Article-No. ELISA

alphaWell Dengue IgG

alpha

alphaWell Chikungunya IgG

alpha

alpha

Chikungunya (Dengue non-endemic area)Italianresident

Chikungunya (Dengue endemic area)Colombianresident

Article-No. Real-time RT PCR

ampliCube Zika Virus (RUO)

ampliCube Chikungunya virus

ampliCube Dengue virus

Primary DengueGermanresident

Primary ZikaGermanresident

(DENV + DENV) (DENV + ZIKV)

Colombianresident

Colombianresident

Article-No. Immunoblot

recomLine Tropical Fever IgG

recomLine Tropical Fever IgM

Article-No. ELISA

alphaWell Dengue IgG

alpha

alphaWell Chikungunya IgG

alpha

alpha

Chikungunya (Dengue non-endemic area)Italianresident

Chikungunya (Dengue endemic area)Colombianresident

Article-No. Real-time RT PCR

ampliCube Zika Virus (RUO)

ampliCube Chikungunya virus

ampliCube Dengue virus

Differentiation of Dengue from Zika and primary from secondary infections

Course of Infection

RNA detection in serum and urine

recomLine Tropical Fever

ampliCube Zika VirusalphaCube Tropical Fever 1

acute phase convalescent phase

Virus

Antibody

IgM

IgG

Page 8: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

React. Contr.

IgG Contr.

Cut-off Contr.

Core 1

Core 2

Helicase

NS3

NS4

NS5

React. Contr.

IgG Contr.

Cut-off Contr.

gp120

gp41

p51

p31

p24

p17

gp105

gp36

Same incubation time for all three assays

Automated processing and interpretation

Native, recombinant HIV / HCV / Treponema antigens

HIV | HCV | Syphilisre

com

Line

HCV

IgG

Differentiation in one step

reco

mLi

ne H

IV-1

& H

IV-2

IgG

React. Contr.IgG

IgM

Cut-off Contr.

Tp47

TmpA

Tp257 (Gpd)

Tp453

Tp17

Tp15

Ig Contr.

reco

mLi

ne T

repo

nem

a Ig

G

reco

mLi

ne T

repo

nem

a Ig

M

Page 9: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

2011

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

2012

2013

2014

2016

2017

2015

0

500

1000

1500

2000

2500

3000

3500

4000

Increasing Numbersof Acute Hepatitis E

Sensitive detection of all four HEV genotypes occuring worldwide

Page 10: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation
Page 11: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

ChlamydiaIdentify Infectious Infertility and Reduce Invasive Imaging

recomLine Chlamydia IgGrecomLine Chlamydia IgA [IgM]

recomWell Chlamydia trachomatis IgG, IgA

recomWell Chlamydia pneumoniae IgG, IgM, IgA

React.-Contr.

Ig Contr.

Cutoff Contr.

MOMP

OMP2

TARP

CPAF

HSP60

MOMP

OMP2

TARP

CPAF

YwbM

MOMP

OMP2

TARP

CPAF

IgGIgAIgM

Chlamydia trachomatis

Chlamydiapneumoniae

Chlamydiapsittaci

Reduced CT and CP cross-reactivities

inconclusive Chlamydia screening results

Diagnosis of fallopian tube infertility. Globally most frequently caused (~30%) by Chlamydia trachomatis

Coming

soon

Page 12: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

recomLine TORCH Screening IgGrecomLine TORCH Screening IgMStrip-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)

TORCH

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. gondiiearly phase antigen ROP1c.

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) 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

Antigen Characteristics

Toxoplasma gondii lysate and recombinant antigen p30

Enables exclusion of a primary infection during the last 3 months if a positive reactivity is detectable for lysate and p30

CMV lysate and recombinant antigen gB2Enables exclusion of a primary infection during the last 6 – 8 weeks if a positive reactivity is detectable for lysate and gB2

Rubella lysate and vaccination bandenables 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

HSV-1/2 lysate and recombinant antigen gG2 for HSV-2 causative agent of genital herpes).

Lysate

React. contr.

Cut-off contr.

Lysate

p30

Lysate

Ru-co

gB2

Conjugate contr. IgGIgM

Lysate

gG2

IgG IgM

Lysate/ROP1cT. gondii

Rubella

CMV

HSV

CE 0483

ChlamydiaIdentify Infectious Infertility and Reduce Invasive Imaging

recomLine Chlamydia IgGrecomLine Chlamydia IgA [IgM]

recomWell Chlamydia trachomatis IgG, IgA

recomWell Chlamydia pneumoniae IgG, IgM, IgA

React.-Contr.

Ig Contr.

Cutoff Contr.

MOMP

OMP2

TARP

CPAF

HSP60

MOMP

OMP2

TARP

CPAF

YwbM

MOMP

OMP2

TARP

CPAF

IgGIgAIgM

Chlamydia trachomatis

Chlamydiapneumoniae

Chlamydiapsittaci

Reduced CT and CP cross-reactivities

inconclusive Chlamydia screening results

Diagnosis of fallopian tube infertility. Globally most frequently caused (~30%) by Chlamydia trachomatis

Coming

soon

Page 13: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

ChlamydiaIdentify Infectious Infertility and Reduce Invasive Imaging

recomLine Chlamydia IgGrecomLine Chlamydia IgA [IgM]

recomWell Chlamydia trachomatis IgG, IgA

recomWell Chlamydia pneumoniae IgG, IgM, IgA

React.-Contr.

Ig Contr.

Cutoff Contr.

MOMP

OMP2

TARP

CPAF

HSP60

MOMP

OMP2

TARP

CPAF

YwbM

MOMP

OMP2

TARP

CPAF

IgGIgAIgM

Chlamydia trachomatis

Chlamydiapneumoniae

Chlamydiapsittaci

Reduced CT and CP cross-reactivities

inconclusive Chlamydia screening results

Diagnosis of fallopian tube infertility. Globally most frequently caused (~30%) by Chlamydia trachomatis

Coming

soon

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

NEW

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 advantagesRecombinant antigens

Easy and clear interpretation due to easy to read bandsEasy test procedure; automation possibleEasy and objective evaluation and documentation by recomScan softwareTest procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable

Separate detection of IgG, IgM and IgA antibodies possibleEasy and reliable determination of avidity possibleCE 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

CE 0483

React. Contr.

Cut-off Contr.

ROP1c

MAG1

GRA7

rSAG1

GRA8

Conjugate Contr.IgGIgAIgM

p30

GRA1

MIC3

Antigen Origin

ROP1c Tachyzoite and bradyzoite antigen

MIC3 Tachyzoite antigen

GRA7 Tachyzoite and bradyzoite antigen

GRA8 Tachyzoite and bradyzoite antigen

p30 Tachyzoite antigen

MAG1 Tachyzoite antigen

GRA1 Tachyzoite and bradyzoite antigen

rSAG1 Tachyzoite antigen

Page 14: High Lights LATAM 2018 Version-BME · Shistosoma mansoni 9 Taenia solium 9 Toxocara canis 9 Toxoplasma gondii + Avidity 99 Trichinella spiralis 9 2PWN?LMQMK? APSXG !F?E?Q 99 Automation

ELISA

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 infectionsCandida

Parasitic infectionsAscaris 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 detectionHuman Papillomavirus (HPV)

AutomationEquipment solutions

Software solutions

Infectious DiseasesYour one-stop shop

Dynex DSX

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MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Germany | Tel.: +49 89 54801-0 | Fax: +49 89 [email protected] | www.mikrogen.de

PIASE001_2013-04

AUTOMATION OF STRIP ASSAYSWith 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.

Automation

Complete automation of strip assays in one - from incubation to result.

Dynablot Plus 1 instrument 31050

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 31009

Scanner to scan test strips directly in the black incubation trays.

Flat bed scanner 1 instrument 31010

Scanner to scan test strips from black evaluation sheets.

recomScan 1 licence 31006

Software for the automatic detection and inter-pretation 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 31043

Software module: Database extension for recomScan for the administration of patient data.

recomScan-PlugIn Import / Export

1 licence 31044

Software module: Extension for recomScan for data exchange with LIM.

recomScan-PlugIn Patient Report

1 licence 31045

Software module: Extension for recomScan for print out of patient reports.

ChlamydiaIdentify Infectious Infertility and Reduce Invasive Imaging

recomLine Chlamydia IgGrecomLine Chlamydia IgA [IgM]

recomWell Chlamydia trachomatis IgG, IgA

recomWell Chlamydia pneumoniae IgG, IgM, IgA

React.-Contr.

Ig Contr.

Cutoff Contr.

MOMP

OMP2

TARP

CPAF

HSP60

MOMP

OMP2

TARP

CPAF

YwbM

MOMP

OMP2

TARP

CPAF

IgGIgAIgM

Chlamydia trachomatis

Chlamydiapneumoniae

Chlamydiapsittaci

Reduced CT and CP cross-reactivities

inconclusive Chlamydia screening results

Diagnosis of fallopian tube infertility. Globally most frequently caused (~30%) by Chlamydia trachomatis

Coming

soon

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TORCH

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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

recomLine CMV

avidity determinationenables to exclude infections <12 weeks

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Human Papilloma-virus | E7Groundbreaking HPV immunoassay – A new era for cervical cancer diagnostics

recomWell HPV 16/18/45recomWell Keratin 5/8/18

Detection of E7 oncoproteins

format

NEW

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MIKROGEN GmbH | Floriansbogen 2-4 | 82061 Neuried | Tel.: +49 89 54801-0 | Fax: +49 89 54801-100www.mikrogen.de | [email protected]

PIREPVE001_2017-09

Article-No. Storage

7904 recomWell HPV 16/18/45Reagents for 96 determinations

At +2°C - +8°C

The sensitivity performance data for the corresponding disease stages were generated by the testing of

true negative (disease-"free”) samples.

N=1574 PPV NPV

*CIN2+ 36.1% (22/61) 99.0% (1498/1513) 59.5% (22/37) 97.5% (1498/1537)

*CIN3+ 58.3% (21/36) 99.0% (1522/1538) 56.8% (21/37) 99.0% (1522/1537)

**CIS / ***CxCa 85.7% (6/7) 98.0% (1536/1567) 16.2% (6/37) 99.9% (1536/1537)

*CIN: cervical intraepithelial neoplasia, **CIS: carcinoma in situ, ***CxCa: cervix carcinoma

Performance Characteristics

Preparation of Patient Samples & Test Principle and Procedure

Indirect sandwich test.

the wells of a microtiter plate.

1st Incubation Add prepared patient sample, and incubate for 1 hour at room temperature.

wash 3 times

2nd Incubation Add ready-to-use secondary anti-HPV E7 antibody, and incubate for 1 hour at room temperature.

wash 3 times

3rd 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 H3PO4 and measure the absorbence at 450 nm.

Turn around time: approx. 4h

E7

E7

E7

Sample preparation.Before performing the recomWell HPV 16/18/45, the cervical smears (stored in ThinPrep® PreservCyt Solution) are processed as follows:

Centrifugation Transfer 15 ml sample material into a screw cap tube with conical bottom. Centrifuge for 15 minutes at 600g. Carefully remove excess supernatant.

Incubation Add 500 µl lysis buffer A, vortex, and incubate for 30 minutes at room temperature. Add 500 µl lysis buffer B and vortex.

B

A B

A

B

A

recomWell HPV 16/18/45

recomWell HPV 16/18/45 – possible usage in the recommended screening algorithm

PurposerecomWell HPV 16/18/45 is a qualitative, in vitro test for detection of E7 oncoproteins from high-risk (hr) human papilloma virus (HPV) types 16, 18 and 45 in cervical smears.

Field of ApplicationrecomWell HPV 16/18/45 can be used in combination with an HPV nucleic

early diagnosis of cervical cancer.

Sample Material

obtain a second sample is not necessary, both tests can be performed with the same sample.

Notes

negative

Result is positive for other high risk HPV types

Follow up in 6-12 months

HPV-PCR

Result is positive for high risk HPV type 16 and/or 18

Routine screening

ColposcopyUse of recomWell HPV 16/18/45 Test

Primary HPV screening

HPV-PCR-testNILM

positive

neg

ativ

e

ASC

-US

Cytology

negative

Result is positive for other high risk HPV types

Follow up in 6-12 months

HPV-PCR

Result is positive for high risk HPV type 16 and/or 18

Routine screening

ColposcopyUse of recomWell HPV 16/18/45 Test

Primary HPV screening

HPV-PCR-test

NILM

ASC

-US

Cytology

negative

Result is positive for other high risk HPV types

Follow up in 6-12 months

HPV-PCR

Result is positive for high risk HPV type 16 and/or 18

Routine screening

ColposcopyUse of recomWell HPV 16/18/45 Test

Primary HPV screening

HPV-PCR-testNILM

ASC

-US

Cytology

oncoprotein detection

E7 oncoprotein

Squamous epithelium

Infectious viral particles

Normal Precancer / Dysplasia Cancer

HPV infection7-30 years

Cervical trans-

Basal layerBasement membrane

Dermis

HPV DNA/RNA

E7E7

E7

E7

E7E7

E7

E7

E7

E7

E7

E7

E7

E7

Degree of risk

Overexpression of HPV oncoprotein E7 during disease progression

2. recom

3. Preparation of Patient Samples & Test Principle and Procedure

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DNA & RNA Extraction

Respiratory InfectionsSexually Transmitted DiseasesGastrointestinal InfectionsTick Borne Infections

Tropical FeverVeterinary Antimicrobial Resistance PCRIn

Development

New

New

Real-Time Single/Multiplex PCR

Molecular Diagnostics

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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

Adenovirus PCR Control 830902

Cytomegalovirus PCR Control (RUO) 830903

Epstein Barr Virus PCR Control 830906

Enterovirus RT-PCR Control 830900

Herpes Simplex Virus Typ 1 PCR Control

830904

Herpes Simplex Virus Typ 2PCR Control

830905

830901

830918

830917

Respiratory Syncytial Virus A RT-PCR Control

830907

Respiratory Syncytial Virus B RT-PCR Control

830908

Rotavirus RT-PCR Control 830909

TBE (Tick Borne Encephalitis Virus) RT-PCR Control

830910

PCR Control830911

Bacteria Article no

Bordetella parapertussis PCR Control

830919

Bordetella pertussis PCR Control 830912

Borrelia burgdorferi PCR Control 830913

Chlamydia pneumoniae PCR Control (RUO)

830914

Streptococcus agalactiae (GBS)PCR Control

830915

Mycobacterium tuberculosis complex (BCG) PCR Control

830916

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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

React. ControlIgG Control

Cut-off Control

RNP68

PNPA

RNPC

SmB

SmD

Ro/SSA60

Ro/SSA52

Rib-P

PCNA

Scl70

Jo-1

Histon

dsDNA

Antinuclear antibodies - ANA

CRESTCalcinosis cutis-Raynaud phe-

-lity-Sclerodactyly-Teleangiecta-sia-syndrome

SLESystemic lupus erythematosus

SLESystemic lupus erythemato-sus

MCTDMixed connectivetissue disease

SLESystemic lupus erythematosus

Sjögren‘s Syndrom

PSSProgressive systemic scleroderma

Myositis

RNPARNPC

RNP68 SmB SmD Ro/SSA52Ro/SSA60SSB

SCL70 Jo-1

Extractable nuclear Antigens - ENA CENPB Rib-P PCNA Histon dsDNA

NEW

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MIKROGEN GmbHFloriansbogen 2-482061 NeuriedGermany

Phone +49 89 54801-0Fax +49 89 54801-100

[email protected] FONEWSE008

+++ new +++ neu +++ new +++

Distribuido por

Sede principal: Cra. 46 No. 128 – 33 Piso 3

Celular: 3013675111Whatsapp: 3168744877

Contacto: [email protected]á, Colombia.

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