Gold Standard Diagnostics Group of Dietzenbach at MEDICA 2020 in Düsseldorf -- MEDICA - World Forum for Medicine
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Gold Standard Diagnostics Group

Waldstr. 23 A6, 63128 Dietzenbach
Germany
Telephone +49 6074 4876-0
Fax +49 6074 4876-29
info@novatec-id.com

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Contact

Rodrigo Berlie

Managing Director
Novatec Immundiagnostica GmbH

Germany

Phone
+49 (0) 6074 48760

Email
info@novatec-id.com

Alexander Berka

Managing Director
Virotech Diagnostics GmbH

Germany

Phone
+49 (0) 6142 69090

Email
info@virotechdiagnostics.com

John Griffiths

Managing Director
Gold Standard Diagnostics Inc.

USA

Phone
+1 (855) 268-6940

Email
info@gsdx.us

Product Orders & Information

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Our range of products

Product categories

  • 02  Laboratory technology
  • 02.01  Analyser systems / equipment
  • 03  Diagnostic tests
  • 03.04  Microbiology testing
  • 03.04.01  Bacteriology testing in microbiology

Bacteriology testing in microbiology

  • 03  Diagnostic tests
  • 03.04  Microbiology testing
  • 03.04.02  Parasitology testing in microbiology
  • 03  Diagnostic tests
  • 03.05  Infectious immunology testing
  • 03.05.02  Microbiological diagnosis, virology, equipment and systems for

Microbiological diagnosis, virology, equipment and systems for

  • 03  Diagnostic tests
  • 03.06  Genetic testing, molecular diagnostics
  • 03.06.03  Polymerase chain reaction (PCR)

Our products

Product category: Analyser systems / equipment

ThunderBolt® ELISA+CLIA Analyzer

The ThunderBolt is an innovative 2-plate, fully automated, open platform that is compact and cost efficient. The user friendly and flexible software is capable of programming a broad range of protocols. The ThunderBolt is available for both ELISA and Chemiluminescent (CLIA) applications.

  • Slide-in racks with positive sample identification
  • Simple workflow software that guides you through the process
  • Designed to suit different laboratory demands
  • High sample loading capacity: 192 primary sample tubes
  • Capable of running many different protocols in a single batch
  • On-board camera allows remote troubleshooting
  • No disposable tips, minimal consumables, direct in-well dilution (up to 1:100)
  • Occupies minimal bench space

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Product category: Analyser systems / equipment

AIX1000® - Automated RPR Syphilis testing

The AIX1000 is an FDA cleared, fully automated system for nontreponemal, rapid plasma reagin (RPR) testing. It has been designed to simplify the processing, analysis, result interpretation, and archiving for RPR screens and semi-quantitative titers.

  • RPR screens & titers
  • Up to 192 results in 90 minutes
  • Full sample traceability: positive specimen ID/Tracking
  • Proprietary image recognition algorithm gives objective results
  • Reduced labor overhead: reduced TAT and hands on
  • Easy access to test results: save data and review on demand

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Product category: Analyser systems / equipment

The Bolt - ELISA+CLIA Analyzer

The fully-automated one-plate processing, modular design – The Bolt shares many features of the ThunderBolt, but with a more customizable, lower throughput, cost-effective design.
  • Program any EIA or CLIA protocol (on-board reader)
  • 96 Sample Capacity
  • Open, fully customizable
  • Convection Incubator
  • High Precision micro-syringe
  • Intuitive User Interface
  • Space Saving Design - Fits standard 60 cm lab bench
  • LIS Connectivity
  • Low Consumable Costs - No disposable tips

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Product category: Polymerase chain reaction (PCR)

GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR

Real-Time PCR test intended for the qualitative determination of SARS-CoV-2 genomic RNA in respiratory samples to aid in the diagnosis of COVID-19. The latest product revision will directly impact your laboratory throughput, doubling your sample capacity with no extra cost.
  • Simultaneous detection of two target sequences
  • Approximately 1 hour turnaround time
  • Sample processing time improved fourfold with 384 run format
  • Reduced reaction volume
  • Increased endpoint fluorescence and robustness of the assay
  • Extraction/inhibition control included
  • Increased volume of Positive Control

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Product category: Polymerase chain reaction (PCR)

GSD NovaPrime® RNA Extraction kits for SARS-CoV-2

As COVID-19 continues to accelerate worldwide, diagnostic laboratories face an unprecedented demand for testing capacity. The use of the GSD NovaPrime® RNA Extraction kits enables laboratories to meet this demand with an easy and highly efficient extraction method. The combination with the GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR represents an excellent molecular diagnostic solution.

  • Easy implementation and short extraction time
  • Magnetic bead technology for automated extraction of genomic SARS-CoV-2 RNA
  • Respiratory samples from clinical specimens (nasal, nasopharyngeal, oropharyngeal)
  • Validated instruments: King Fisher™ Flex System, Maelstrom 9600, and MGI MGISP-960

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Product category: Immuno assay testing

SARS-CoV-2 (COVID-19) ELISA Assays

Enzyme-Linked Immunosorbent Assays (ELISA) intended for the qualitative determination of antibodies against SARS-CoV-2 in human serum or plasma to aid in the diagnosis of COVID-19.

  • Separate detection of IgG, IgA, and IgM antibodies
  • SARS-CoV-2 Nucleocapsid recombinant antigen
  • Ideal complement to RT-PCR
  • Ready-to-use controls
  • Results in under 2 hours
  • Assay procedure is easy to automate
  • Works on several open ELISA systems (protocols available)
  • CE-IVD

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Product category: Immuno assay testing

NovaTec ELISA Portfolio (NovaLisa® )

NovaLisa® is the IVD ELISA Kits product line for the human market. We offer a wide range of products with focus on Infectious Diseases: Virology, Bacteriology, Parasites, Worms and Fungi. All the reagents are ready to use and user friendly.

  • CE approved
  • Standardized methods
  • Ready-to-use, color-coded reagents
  • Special IgM-buffer to avoid interferences with rheumatoid factors
  • EIAs with cut-off-controls
  • Snap-off microtiter strips
  • QC performed manually as well as on several automated systems
  • Avidity tests available

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Product category: Immuno assay testing

NovaLisa® Arboviruses

The NovaLisa® kits for the diagnosis of Dengue, Zika, and Chikungunya are intended for the qualitative detection of antibodies to these viruses in human serum or plasma.

  • Ready-to-use reagents
  • Highly specific antigens (NS1 for Zika virus)
  • μ-capture technology available for optimized sensitivity and specificity
  • Zika IgM μ-capture has been tested with samples from pregnant women
  • Low cross-reactivity compared to conventional diagnostic test systems
  • Widely used in scientific studies in epidemiological areas
  • CE-IVD

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Product category: Immuno assay testing, Parasitology testing in microbiology

NovaLisa® Malaria

The NovaLisa® Malaria antibody assay is a fast and sensitive enzyme immunoassay for the detection of total antibodies against Plasmodium spp. in human serum or plasma.

  • Ready-to-use reagents
  • Recombinant antigens of P. falciparum and P. vivax
  • P. ovale, P. malariae, and P. knowlesi are also detected due to the antigenic similarity between the different Plasmodium species
  • Low cross-reactivity to other parasites or vector-borne transmitted viruses
  • Diagnostic Sensitivity: 95.88% ; Diagnostic Specificity: 97.53%
  • CE-IVD

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Product category: Immuno assay testing

NovaTec VetLine Portfolio

VetLine is the ELISA Kits product line for the veterinary market. We offer a wide range of products for antibody detection in a wide range of species: canine, feline, bovine, porcine, caprine, and poultry.

  • Ready to use and colour coded reagents
  • Standardized procedures
  • EIAs with cut off control
  • Easy to use on automated systems
  • Snap-off microtiter strips
  • Long shelf-life
  • Assay dependant sample types: serum, plasma, urine, milk
  • Pooled samples

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Product category: Parasitology testing in microbiology, Immuno assay testing

NovaTec VetLine Leishmania ELISA

The NovaTec VetLine Leishmania ELISA is intended for the qualitative determination of antibodies against Leishmania in veterinary serum.

  • Ready-to-use reagents and colour coded reagents
  • Standardized procedures
  • Includes Negative Control, Cut-off Control, and Positive Control
  • Objective result interpretation in contrast to IFT
  • Diagnostic Sensitivity: 95.80% ; Diagnostic Specificity: 95.43%
  • Widely used in Labchains
  • Easy to use on automated systems
  • Long shelf-life

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Product category: Immuno assay testing

VIROTECH VZV ELISA

The VIROTECH VZV IgG/IgM ELISA + VZV IgA-Set is intended for the qualitative detection of IgG-, IgM- and IgA-antibodies against VZV in human serum. It is intended for differentiation respectively check of seronegativity, primary infection, past infection, reactivation and to determine if vaccination is necessary respectively has been successful.

  • In IgG adjusted to the international WHO-standard
  • Highly specific results in IgM due to a special dilution buffer
  • Validated for CSF diagnostics
  • Color-coded, breakable microtiterplates
  • Test result after approx. 100 min
  • Advantages of the VIROTECH ELISA system
  • Automated processing possible
  • CE-IVD

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Product category: Immuno assay testing

VIROTECH FSME / TBE ELISA

The VIROTECH FSME/TBE IgG/IgM ELISA is intended for the detection of an acute or recent infection with Tick-Borne-Encephalitis-Virus (TBE) or for the detection of vaccination antibodies.

  • Detection of seroconversion after vaccination
  • Detection of an apparent or inapparent infection with the TBE virus
  • Antibody progression control after infection
  • Validated for CSF diagnostics in IgG
  • Color-coded, breakable microtiterplates
  • Test result after approx. 100 min
  • Advantages of the Virotech ELISA system
  • Automated processing possible
  • CE-IVD

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Product category: Immuno assay testing

VIROTECH Masern / Measles ELISA

The VIROTECH Masern/Measles IgG ELISA and the VIROTECH Masern/Measles IgM ELISA is intended for the detection of an acute or recent infection with Measles respectively for the detection of vaccination antibodies.

  • In IgG adjusted to the 2nd and 3rd International Standard of the WHO
  • Validated in IgG for CSF diagnostics
  • Color-coded, breakable microtiter plates
  • Test result after approx. 100 min
  • Advantages of the VIROTECH ELISA system
  • Automated processing possible
  • CE-IVD

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Product category: Immuno assay testing

VIROTECH ELISA portfolio

The Virotech Diagnostics ELISA product portfolio offers a wide range of qualitative and quantitative serological test systems for the most relevant infectious diseases. They serve as tools to diagnose specific IgG, IgM and IgA antibodies in human serum. Furthermore, the Virotech system ensures a high level of flexibility by offering the possibility to apply dilution buffer, washing buffer, TMB, citrate stop solution as well as conjugates for all parameters.

  • Wide product range consists of >60 CE marked ELISA test systems
  • 1 test procedure for > 60 assays
  • Test result after approx. 100 min
  • System diagnostics: Lot- and parameter-independent components
  • Color-coded, breakable microtiter plates
  • Automated processing possible
  • CE-IVD

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Product category: Immuno assay testing

VIROTECH LINE Immunoblot portfolio

Virotech Diagnostics LINE Immunoblots serve the qualitative detection of pathogen-specific IgG, IgM and IgA antibodies in human serum. The coated nitrocellulose test strips enable a high degree of flexibility by covering various system components. Microdispension of antigens at defined positions on the nitrocellulose ensures high reproducibility. Easy reading and interpretation of Virotech Diagnostics LINE Immunoblots can be done visually as well as by utilizing a user-friendly evaluation software.

  • Solid strips stabilised on a plastic foil
  • Quality control on each strip
  • Test results after approx. 100 minutes
  • Parameter- and lot independent components
  • Positive and negative controls separately available
  • CE-IVD

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Product category: Immuno assay testing

VIROTECH Cerebrospinal Fluid product portfolio

In addition to serology, VIROTECH Diagnostics ELISAs can be used for detecting pathogen-specific antibodies in CSF within the established system. The determination of the antibody-index follows the Reiber system. VIROTECH also offers Antibody-Index-Controls for ensuring quality control of the daily CSF routine diagnostics.

  • Parallel CSF-/Serum procedure on one plate (incl. serology)
  • 4 Ready to use CSF Standards or VIROTECH Diagnostics internal evaluated values for a fix standard curve
  • Uniform serum and CSF dilution and incubation times
  • Antibody-Index-Controls available
  • Color-coded, breakable microtiterplates
  • Test result after approx. 100 min
  • Advantages of the VIROTECH ELISA system
  • Automated processing possible
  • CE-IVD

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Product category: Parasitology testing in microbiology

NovaLisa® Strongyloides

The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or
plasma (citrate or heparin).

  • Chimeric recombinant antigen to increase specificity
  • Detects the main human pathogen species.
  • Diagnostic Sensitivity: 89.47%;  Diagnostic Specificity: 94.12%
  • Ready to use reagents with standardized procedures
  • EIAs with cut off control
  • Color coded reagents
  • Easy to use on automated systems
  • CE-IVD

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Product category: Parasitology testing in microbiology

NovaLisa® Toxocara canis IgG

The Toxocara canis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Toxocara canis in human serum or plasma (citrate, heparin).

  • Diagnostic Sensitivity: 96.92%; Diagnostic Specificity: 98.63%
  • Ready to use reagents with standardized procedures
  • EIAs with cut off control
  • Color coded reagents
  • Easy to use on automated systems
  • CE-IVD

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Product category: Bacteriology testing

NovaLisa® Borrelia burgdorferi ELISA

The Borrelia burgdorferi ELISA kits (IgG and IgM presentations) are intended for the qualitative determination of antibodies against Borrelia burgdorferi in human samples. 

  • Ready-to-use and colour coded reagents
  • Recombinant antigens
  • Validated for CSF (cerebrospinal fluid), serum, and plasma samples
  • Diagnostic Sensitivity: 98.39%; Diagnostic Specificity: 95.48%
  • CE-IVD

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Product category: Bacteriology testing

NovaLisa® Chlamydia Assays

Full panel available:
  • Chlamydia trachomatis IgA
  • Chlamydia trachomatis IgG
  • Chlamydia trachomatis IgM
  • Chlamydia pneumoniae IgA
  • Chlamydia pneumoniae IgG
  • Chlamydia pneumoniae IgG

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Product category: Bacteriology testing

VIROTECH Borrelia Diagnostic - ELISA and LINE Immunoblots

The Borrelia IgG and IgM ELISA serve as screening test for the qualitative detection of IgG and IgM antibodies to Borrelia burgdorferi sensu lato. In the second step the Borrelia LINE immunoblot test kits are used for the qualitative detection of Borrelia burgdorferi sensu lato specific IgG or IgM antibodies and thus serve as confirmatory test for a complete Borrelia diagnostic.

  • ELISA and LINE can be processed in the Virotech system
  • Antigens from the recommended European strains B. afzelii strain PKo, B. garinii strain PBr and B. burgdorferi strain ZS7
  • Combination of native highly purified and recombinant antigens on the LINE products
  • Borrelia LINEs with additional exclusion markers for EBV primary or syphilis infection available
  • All Borrelia products are validated for CSF diagnostics
  • Color-coded, breakable microtiterplates
  • Test result after approx. 100 min
  • Advantages of the Virotech ELISA / LINE system
  • Automated processing possible
  • CE-IVD

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Product category: Bacteriology testing

VIROTECH Vaccination Panel - Tetanus, Diphtheria and Bordetella ELISA

The VIROTECH Diphtheria and Tetanus IgG ELISA allow the quantitative detection of IgG antibodies against the Diphtheria-Toxin or Tetanus-Toxoid for monitoring of vaccination success and determination of immune status. The VIROTECH Bordetella pertussis Toxin (PT) IgG ELISA is used for the detection of vaccination antibodies as well as for the detection of acute or recent infections.

  • Adjusted to WHO standard
  • Quantification in IU/ml
  • Evaluation using 1-point-quantification or standard curve
  • Color-coded, breakable microtiter plates
  • Test result after approx. 100 min
  • Advantages of the Virotech ELISA system
  • Automatic processing possible
  • CE-IVD

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Product category: Bacteriology testing

VIROTECH Treponema pallidum LINE Immunoblot - IgG and IgM antibody detection tests

The VIROTECH Treponema pallidum LINE Immunoblot Testkit is for the qualitative detection of Treponema pallidum specific IgG- respectively IgM- antibodies in human serum. The Kit can be used as confirmation test for an extended Syphilis diagnostic, in case the result of the screening test is doubtful (suspicious) or positive.

  • By using recombinant proteins, a high specificity for all stages of infection is achieved
  • For the detection of primary, secondary and latent syphilis
  • Test result after approx. 100 min
  • Advantages of the Virotech LINE System
  • Automatic processing possible
  • CE-IVD

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Product category: Bacteriology testing

VIROTECH Pertussis Portfolio

VIROTECH Diagnostics offers a broad portfolio for your pertussis diagnostics: The VIROTECH Bordetella pertussis (FHA+PT) IgG/IgA ELISA functions as a screening test and serves for the qualitative detection of IgG and IgA antibodies against PT and FHA in human serum. The VIROTECH Pertussis Toxin (PT) ELISA detects specifically IgG, IgM and IgA antibodies against the highly specific Pertussis Toxin (PT) in human serum. In addition to the ELISA diagnostics we offer the VIROTECH B.pertussis + CatACT LINE IgG/IgA immunoblot.

  • VIROTECH Bordetella pertussis (FHA+PT) ELISA: Sensitive screening test for the qualitative detection of IgG and IgA antibodies against PT and FHA
  • VIROTECH Pertussis Toxin (PT) ELISA: Detection of IgG, IgM and IgA antibodies against the highly specific Pertussis Toxin (PT) for the detection of an infection or the detection of vaccination antibodies (vaccination success control). Quantification in IgG in international units per millilitre (IU/ml) possible.
  • VIROTECH B.pertussis + CatACT LINE IgG/IgA Immunoblot: For detection of Bordetella pertussis infections. Differentiation between infection and vaccination possible. Evidence of a Boretella parapertussis infection. 
  • Color-coded, breakables microtiterplates
  • Test result after apprx. 100 min
  • Benefits of the Virotech ELISA/LINE system
  • Automatic processing possible
  • CE-IVD

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Company news

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Oct 20, 2020

SARS-CoV-2 Real-Time PCR & Extraction Kits

The Gold Standard Diagnostics Group is excited to offer the GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR kit in combination with the GSD NovaPrime® RNA Extraction kits. Benefit now from a complete molecular solution with high sensitivity and efficiency in the overall workflow.

GSD NovaPrime® RNA Extraction kits
  • Magnetic-particle technology for automated extraction of genomic SARS-CoV-2 RNA
  • Easy implementation and short extraction time
  • Respiratory samples from clinical specimens
  • Validated instruments: King Fisher™ Flex System, Maelstrom 9600, and MGI MGISP-960
GSD NovaPrime® SARS-CoV-2 (COVID-19)
  • Simultaneous detection of two target sequences.
  • Approximately 1 hour TAT
  • No cross reactivity with common human coronavirus strains.
  • Extraction/inhibition control and positive control included.

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About us

Company details

The Gold Standard Diagnostics Group is a leading healthcare provider of diagnostic solutions composed by three companies with extensive experience in the clinical market: Gold Standard Diagnostics Inc., NovaTec Immundiagnostica GmbH, and Virotech Diagnostics GmbH.

Uniting their combined core competencies, the group provides automated platforms and a broad test menu of diagnostic tests in the fields of virology, bacteriology, parasitology, mycology, tumor markers, hormones and autoimmune diseases.

With new R&D capabilities, Gold Standard Diagnostics (GSD) is committed to provide the highest quality assays and services to its vast laboratory network worldwide, and will continue to devote all of its efforts to improving patient care.

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Company data

Area of business
  • Laboratory Equipment
  • Diagnostics