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+++ neu +++ new +++ neu
HIGHLIGHTS – 2018
MIKROGEN – BASED IN MUNICH, GERMANY
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
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
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
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
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
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
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 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
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
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
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
TORCH
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
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
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
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
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
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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