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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
D I S E A S EI N F E C T I O U SI N F E C T I O U S D I S E A S E
2 0 1 5 / 2 0 1 6 P roduc t Ca ta log
4 INF
ELISA ASSAYS
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 directive 98/79/EC. 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
The Virotech ELISA System
INFECTIOUS DISEASE SEROLOGY / ELISA
PRODUCT FORMAT ORDER NUMBER FEATURES
INF 5
Adenovirus ELISA
IgG / IgM Testkit 96 wells EC121.00 Can be processed in one run with all other kits
IgA Set Set EC121.08 of the respiratory panel
Bordetella pertussis ELISA
IgG / IgA Testkit 96 wells EC115.00 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 3 x 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 Antibody-Index-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 Antibody-Index-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
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 DC122.00 Sensitive IgG antibody screening of dog or
IgM Set dog Set DC122K80 horse serum
Brucella ELISA
IgG / IgM Testkit 96 wells EC101.00 Detects Brucella abortus, Brucella
IgA Set Set EC101.08 melitensis and Brucella suis
Candida albicans ELISA
IgG / IgM Testkit 96 wells EC111.00 Adjusted to primarily detect acute
IgA Set Set EC111.08 infections in IgG
CMV ELISA
IgG / IgM Testkit 96 wells EC113.00 Very sensitive mix of native and
IgG CSF Standards Standards EC113L60 recombinant antigens
Diphtheria ELISA
IgG Testkit 96 wells EC129.00 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 EC102.00 EBV screening ELISA
IgG CSF Standards Standards EC102L60 A diagnostic statement with regard to
IgG Antibody-Index-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 EC202.00 “Early Antigen-Diffuse” belongs to the early
antigens, which are synthesised in the viralreplication cycle (acute phase of infection)
Please note that some products listed may not be available in all markets.
INFECTIOUS DISEASE SEROLOGY / ELISA
PRODUCT FORMAT ORDER NUMBER FEATURES
6 INF
ELISA ASSAYS
EBV EBNA 1 ELISA
IgG Testkit 96 wells EC204.00 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 markers
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 EC130.00 High-specific recombinant glycoprotein gG1
IgG CSF Standards Standards EC130L60
HSV 2 (gG2) ELISA
IgG / IgM Testkit 96 wells EC131.00 High-specific affinity-purified glycoprotein gG2
IgG CSF Standards Standards EC131L60
HSV Screen ELISA
IgG / IgM Testkit 96 wells EC108.00 Screening of IgG and IgM of HSV 1and HSV 2
IgG CSF Standards Standards EC108L60 in one assay
IgA Antibody-Index-Control 4 x 1 mL EN108L45
IgG Antibody-Index-Control 4 x 1 mL EN108L65
Influenza A ELISA
IgG / IgM Testkit 96 wells EC118.00 Up to date antigens as per seasonal
IgA Testkit 96 wells EC118A00 recommendation of the WHO
Influenza B ELISA
IgG / IgM Testkit 96 wells EC119.00 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 Antibody-Index-Control 4 x 1 mL EN105L65
Mumps ELISA
IgG / IgM Testkit 96 wells EC106.00 Complete package of serum and
IgG CSF Standards Standards EC106L60 CSF diagnostic
Mycoplasma pneumoniae ELISA
IgG / IgM Testkit 96 wells EC114.00 Cut-off adjustment to detect acute infections
IgA Set Set EC114.08 in IgG. Specific infants cut-off adjustment.
Mycoplasma pn. polyvalent ELISA
IgG/IgA+M Testkit 96 wells EC214.00 Efficient diagnostic due to simultaneous detection
of IgA & IgM antibodies with one polyvalentconjugate. Cut-off adjustment to detect acute infections in IgG. Specific infants cut-off adjustment.
Please note that some products listed may not be available in all markets.
INFECTIOUS DISEASE SEROLOGY / ELISA
PRODUCT FORMAT ORDER NUMBER FEATURES
INFECTIOUS DISEASE SEROLOGY / ELISA — PREABSORPTION OF RHEUMATOID FACTORS
PRODUCT FORMAT ORDER NUMBER FEATURES
INF 7
ParaScreen ELISA
IgG / IgM Testkit 96 wells EC148.00 Detects Parainfluenza 1-3 in one test run
IgA Set Set EC148.08
RSV ELISA
IgG / IgM Testkit 96 wells EC107.00 Can be processed in one run with all other kits
IgA Set Set EC107.08 of the respiratory panel
Rubella ELISA
IgG CSF Testkit 96 wells EC109L00 CSF Diagnostic for IgG, AI-Controls for IgG
IgG CSF Standards Standards EC109L60
IgG Antibody-Index-Control 4 x 1 mL EN109L65
TBE ELISA
IgG / IgM Testkit 96 wells EC117.00 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 Antibody-Index-Control 4 x 1 mL EN117L65
Tetanus ELISA
IgG Testkit 96 wells EC124.00 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 EC110.00 IgG adjusted as recommended by the
IgA Set Set EC110.08 Robert-Koch-Institute (aligned to the WHO
IgA CSF Standards Standards EC110L40 standard: > 100IU/l = seropositive titer)
IgG CSF Standards Standards EC110L60
IgM CSF Standards Standards EC110L80
IgG Antibody-Index-Control 4 x 1 mL EN110L65
Yersinia enterocolitica ELISA
IgG / IgA Testkit 96 wells EC142.00 Mix of purified native antigens and recombinant
antigens YopD, YopB & YopE
RF-SorboTech vial – 2 mL 161101 Rheumatoid factor absorbent for all IgM and
IgA+M ELISA tests and Pertussis Toxin IgA ELISA
RF-SorboTech vial – 10 mL 161102 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/300.00 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/300.11 Rheumatoid factor absorbent for all IgM and
40 tubes with IgA+M ELISA tests and Pertussis Toxin IgA ELISA
450 µl dilution
buffer each
Please note that some products listed may not be available in all markets.
INFECTIOUS DISEASE SEROLOGY / ELISA — SINGLE COMPONENTS FOR HUMAN SEROLOGY EIA
PRODUCT FORMAT ORDER NUMBER
ELISA ASSAYS
8 INF
Tetramethylbenzidine – Substrate Solution 11 mL 151101
PBS-Washing Solution (20x concentrated) 50 mL 141201
Citrate-Stopping Solution 6 mL 141101
PBS-Dilutionbuffer (blue, ready to use) 50 mL 141301
VZV-IgM-Dilutionbuffer (green, ready to use) 50 mL 141401
IgA-Conjugate (anti-human) 11 mL 131301
IgA-Conjugate 2 (anti-human) 11 mL 131601
IgA+M Conjugate 11mL 131401
IgG-Conjugate (anti-human) 11 mL 131101
IgM-Conjugate (anti-human) 11 mL 131201
12 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 Standard-Control-Set
Tetanus ELISA Set EN124K60
IgG Standard-Control-Set
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.
Please note that some products listed may not be available in all markets.
VALIDATION OF ELISA PROCESSORS
PRODUCT FORMAT ORDER NUMBER FEATURES
VIROTECH ELISA ASSAYS - PACKAGE CONTENTS
INF 9
Validation Kit, ELISA 96 wells EC250.00 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 EC250.00
Semiquantitative ELISA Testkits, ECXXX.00
• 12 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-, IgM-
or IgG-antibodies in Cerebrospinal Fluid.
ENXXXL65, ENXXXL45 Antibody-Index-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
Please note that some products listed may not be available in all markets.
10 INF
LINE ASSAYS
The Virotech Line Immuno Assays (LIA) 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
The Virotech LINE System
INFECTIOUS DISEASE SEROLOGY LINE
PRODUCT FORMAT ORDER NUMBER FEATURES
INF 11
B. pertussis + CatACT LINE
IgA Line Immunoblot 32 strips WE116A32 New marker CatACT allows differentiation between
IgA Line Immunoblot 96 strips WE116A96 vaccination and infection. Note towards
IgA cut off control 0,5 mL WE116C40 parapertussis possible.
IgA positive control 0,5 mL WE116P40
IgG Line Immunoblot 32 strips WE116G32
IgG Line Immunoblot 96 strips WE116G96
IgG cut off control 0,5 mL WE116C60
IgG positive control 0,5 mL WE116P60
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 32 strips WE222M32 EBV-band as exclusion marker in IgM diagnostics.
IgM Line Immunoblot 96 strips 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 WE225N60
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
Please note that some products listed may not be available in all markets.
INFECTIOUS DISEASE SEROLOGY LINE
PRODUCT FORMAT ORDER NUMBER FEATURES
12 INF
LINE ASSAYS
Helicobacter pylori LINE
IgA Line Immunoblot 32 strips WE243A32 Therapy-relevant differentiation of virulent and
IgA Line Immunoblot 96 strips WE243A96 non-virulent strains via CagA and VacA
IgA cut off control 0,5 mL WE243C40
IgA positive control 0,5 mL WE243P40
IgG Line Immunoblot 32 strips WE243G32
IgG Line Immunoblot 96 strips WE243G96
IgG cut off control 0,5 mL WE243C60
IgG positive control 0,5 mL WE243P60
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.)
IgA Line Immunoblot 16 strips WE214A16 The only commercially available LINE, with
IgA cut off control 0,5 mL WE214C40 an ideal combination of established
IgA positive control 0,5 mL WE214P40 (P1) & new antigens (P200, P400)
IgG Line Immunoblot 16 strips WE214G16
IgG cut off control 0,5 mL WE214C60
IgG positive control 0,5 mL WE214P60
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
Yersinia enterocolitica LINE
(recomb.)
IgA Line Immunoblot 32 strips WE242A32 Prevalence band YopDD in IgG shows
IgA Line Immunoblot 96 strips WE242A96 contact with the pathogen
IgA cut off control 0,5 mL WE242C40
IgA positive control 0,5 mL WE242P40
IgG Line Immunoblot 32 strips WE242G32
IgG Line Immunoblot 96 strips WE242G96
IgG cut off control 0,5 mL WE242C60
IgG positive control 0,5 mL WE242P60
IgG/IgA negative control 0,5 mL WE242N20
Please note that some products listed may not be available in all markets.
INFECTIOUS DISEASE SEROLOGY LINE — SINGLE COMPONENTS FOR LINE TEST KITS
PRODUCT FORMAT ORDER NUMBER
INFECTIOUS DISEASE SEROLOGY LINE — DOG KIT (BASIS KIT) WITH ADDITIONAL HORSE SET
PRODUCT FORMAT ORDER NUMBER FEATURES
INF 13
IgG-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.62
IgM-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.82
IgA-conjugate (anti-human, 100x concentrated) 0,7 mL WE400.42
Dilution- / Washbuffer (10x concentrated) 50 mL WE200.08
Substrate Solution (BCIP/NBT, ready to use) 57 mL WE200.02
Incubationtray with 42 cavities, to be used with the Apollo automates 1 pcs WE300.42
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 WE300.08
Record Sheet 1 booklet WE301APB
Borrelia Veterinary plus OspA 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
Please note that some products listed may not be available in all markets.
LABIMAGE® LA- LINE INTERPRETATION SOFTWARE
PRODUCT FORMAT ORDER NUMBER FEATURES
LabImage® Package 1 F/LabImage 1 LabImage® Reader plus PC
LabImage® Software (CD)
Virotech SetCards (CD)
Manuals
LabImage® Package 2 F/LabImage 2 LabImage® Reader without PC
LabImage® Software (CD)
Virotech SetCards (CD)
Manuals
License-Dongle
LabImage® Package 3 F/LabImage 3 Flat Bed Scanner (Plustek)
LabImage® Software (CD)
Virotech SetCards (CD)
Manuals
License-Dongle
14 INF
LINE ASSAYS
SERAMUN AUTOIMMUN DIAGNOSTICS – SERALINE®
PRODUCT FORMAT ORDER NUMBER FEATURES
Seraline® Zöliakie-3 IgG 20 strips HW/LIA-001-3G Line Immunoassay for detection of IgG antibodies
to Gliadin, Tissue Transglutaminase (tTG) and
Mannan in human serum or plasma.
Seraline® Zöliakie-3 IgA 20 strips HW/LIA-001-3A Line Immunoassay for detection of IgA antibodies
to Gliadin, Tissue Transglutaminase (tTG) and
Mannan in human serum or plasma.
Seraline® ANA-12 IgG 20 strips HW/LIA-002-12G Line Immunoassay for detection of IgG-antibodies
in connective tissue diseases in human serum or
plasma.
Seraline® Vaskulitis-3 IgG 20 strips HW/LIA-003-3G Line Immunoassay for detection of IgG-antibodies
in systemic vasculitis in human serum or plasma.
Seraline® HepAk-7 IgG 20 strips HW/LIA-004-7G Line Immunoassay for detection of
igG-autoantibodies in autoimmune liver diseases in
human serum or plasma.
Please note that some products listed may not be available in all markets.
SERALINE® ADVANTAGES & EXAMPLES:
• Detection of multiple auto-antibodies in one test run
• Solid strips stabilised on a plastic foil and sorted strips in a booklet
• Cut-off control on each strip
• Ready to use & coloured conjugate
SERAMUN AUTOIMMUN DIAGNOSTICS – SERALINE®
SERALINE® ZÖLIAKIE SERALINE® ANA-12 SERALINE® VASKULITIS SERALINE® HepAk PLUS
function control
IgG
IgA
Cut off control
Gliadin
tTG
Mannan
function control
Cut off control
dsNDA
Nucleosomes
Sm
P0
Histones
U1 snRNP
Ro/SS-A(60kDa)
Ro/SS-A(52kDa)
La/SS-B
Scl-70
CENP-B
Jo-1
conjugate control
function control
Cut off control
PR3
MPO
GBM
function control
Cut off control
AMA/M2
LKM1
LC1
SLA
F-Actin
gp210
Sp100
CLINICAL CHEMISTRY REAGENTS
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 Stool ELISA
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
INF 15
16 INF
ELISA ASSAYS
SERAMUN ANTIGEN DETECTION TESTS — ELISA (TEST MATERIAL: HUMAN STOOL SAMPLES / CULTURE MATERIAL)
BACTERIA FORMAT ORDER NUMBER FEATURES
VIRUSES FORMAT ORDER NUMBER FEATURES
PARASITES 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 1 + 2 96 wells HW/E-030 Sensitive detection with a biotin/streptavidin
Serazym® Verotoxin 1 + 2 2 x 96 wells HW/E-030-A2 conjugate system of Verotoxin 1 & 2
(Shiga Toxin 1 & 2) in stool and culture samples
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 60-10 min
Serazym® Norovirus 96 wells HW/E-061 Detection of Norovirus capsid proteins
Serazym® Norovirus 2 x 96 wells 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
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 ( >105 mL)
Serazym® Giardia lamblia 96 wells HW/E-106-A Sensitive detection of cyst-wall-protein 1 (CWP-1)
despite intermittent excretion
Please note that some products listed may not be available in all markets.
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.
CLINI-CAL
20 INF
ELISA/LINE ASSYS
Locations
Sekisui Diagnostics (UK) Ltd.Allington, Maidstone
Kent, UK
+44-1622-607800
Sekisui Virotech GmbHRüsselsheim, Germany
+49-6142-6909-0
Sekisui Diagnostics GmbHPfungstadt, Germany
+49-6157-990899
Sekisui Medical Co., Ltd.Tokyo, Japan
+81-3-3272-0671
Sekisui Medical Technology (China) Ltd.Shunyi District, Beijing, China
+86-10-8048-6325
Sekisui Medical Technology (China) Ltd.Chaoyang District, Beijing, China
+86-10-6269-2662
Worldwide HQSekisui Diagnostics, LLCLexington, MA, USA
+1 781-652-7800
Sekisui Diagnostics, LLCSan Diego, CA, USA
+1 858-777-2600
Sekisui Diagnostics, LLCExton, PA, USA
+1 610-594-8590
Sekisui Diagnostics, LLCStamford, CT, USA
+1 203-602-7777
Sekisui Diagnostics P.E.I. Inc.Charlottetown, PEI, Canada
+1 902-566-1396
80-8231-00-02 10/15
Other trademarks used here in are owned by their respective companies
OSOM® is a registered U.S. trademark of Sekisui Diagnostics, LLC.
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www.sekisuidiagnostics.com