Molecular Diagnostics

Leading-edge solutions enabling better medical decisions.
ELITechGroup is a leading PCR innovator with the revolutionary Minor Groove Binder (MGB) technology and a global solution provider for Molecular Diagnostics.
Our products deliver superior performance, enabling more accurate diagnoses for patient treatment and monitoring of organ and stem cells transplant, immunocompromised patients, infectious diseases, healthcare associated Infections, onco-hematology and human genetics.
ELITechGroup Molecular Diagnostics has pioneered developments in molecular diagnostics, bringing trusted results to laboratories, giving clinicians the tools to make fast and accurate medical decisions and improve clinical outcomes.

Products

Elite InGenius®

Elite InGenius® is the first CE-IVD fully automated sample-to-result solution, integrating sample preparation, amplification and result analysis, validated with a quantitative transplant pathogen monitoring menu.

The Elite InGenius® is a fully automated Molecular Diagnostics system performing automatically the following tasks: nucleic acid extraction and purification from a large panel of biological specimens, amplification and detection of the nucleic acid extracted by RT-PCR and result analysis.

The ELITe InGenius is a highly flexible solution operating as a closed system in combination with the ELITe MGB® RT-PCR line to offer a unique CE-IVD solution for infectious disease testing AND operating as an open system, compatible with a large range of PCR chemistries.

This unique system can processed from 1 to 12 samples in parallel and independent tracks. It features a universal extraction process in prefilled unitary cartridge associated with multiple and independent PCR from one or several extracted samples enabling the laboratories to develop and custom testing panels according to their specific needs.

Several working modes are available: sample preparation only, RT-PCR amplification only, or sample preparation, amplification and result analysis for qualitative and quantitative applications.

The intuitive and clear graphic user interface piloted with a touch screen guide the user step by step during routine daily works and interfaced with the Laboratory Informatics System (LIS).

Catalogue Number(s)

INT030
Product Description: EElite InGenius® – Sample-to-result instrument with touch screen

INT032SP200
Product Description: Elite InGenius® SP 200 – Pre-filled reagents for universal kit extraction
Number of Tests: 48

INT032CS
Product Description: Elite InGenius® SP 200 Consumable Set – 48 tip cassettes, 48 sonication tubes & caps, 48 elution tubes & caps
Number of Tests: 48

INT035PCR
Product Description: Elite InGenius® PCR Cassette – Aspecific PCR Reaction Cassette & PCR Cap
Number of Tests: 192

F2102-000
Product Description: Elite InGenius® Waste Box – Plastic bag for tip trash
Number of Tests: 20

TF-350-L-R-S
Product Description: Filter tips 300
Number of Tests: 10 x 96

ELITe InGenius MGB® Meningitis Viral Panels

Puteaux, France, 6th July 2017 – ELITechGroup Molecular Diagnostics, announces today the launch of a high-performance real-time PCR assay: Meningitis Viral 2 ELITe MGB® Panel for viral meningitis diagnosis, validated with ELITe InGenius, ELITechGroup’s fully automated sample to result system.

Viruses are the most common causative agent of meningitis. Although presenting similar onset, viral and bacterial meningitis are associated with entirely different outcomes. Rapid and accurate diagnosis by molecular method is important to identify the viral agent, rule out a bacterial infection, and adapt patient management.

Meningitis Viral ELITe MGB® Panel 2 is a multiplex assay validated with cerebrospinal fluid samples, which combines reverse transcription, and real-time PCR amplification for the detection and the differentiation of Enterovirus, Parechovirus and Adenovirus in one single reaction. The clinical studies have demonstrated excellent performance: 100% diagnostic sensitivity and 100% specificity for all targets.

The validation with the ELITe InGenius system offers several advantages to laboratories: results in only 2h30 with limited hands-on time, emergency testing performed in parallel of any routine samples within the same run, and storage of extracted nucleic acid for an optimal use of precious CSF samples for retesting, additional molecular testing, or archiving.

The ELITe InGenius menu for molecular diagnostics of meningitis will be further broadened in the coming months, with an additional real-time PCR multiplex assay for the detection of the main causative agents of bacterial meningitis.

Information request Benelux

ACCURUN Controls

Consistent accuracy is non-negotiable.

Serology Controls

  • Specifically formulated as a low level positive sample for manual and automated platforms
  • Ready to use—no reconstitution or special handling required; most stable at refrigerated temperatures
  • Enable your lab to meet compliance requirements of regulatory agencies and professional organizations

 

Nucleic Acid Controls: our comprehensive line of PCR and hybrid-capture

NAT controls are formulated using intact virus or microorganisms

  • Help your lab monitor all aspects of sample testing—sample lysis and extraction through target or signal amplification to detection
  • Formulated at different levels to effectively challenge assay performance and monitor results at clinical decision points

 

Genetic Controls: setting a new standard for error detection

  • Muliple alleles per vial allow your lab to run more samples and fewer controls
    • Optimizes instrument capacity, especially for multiplexed assays
  • Eliminate more test errors, run more samples and fewer controls

Cycler Validation

Validation tools for testing PCR thermal cyclers according to legal requirements

Validation tools for testing PCR thermal cyclers according to legal requirements

 Thermal Cycler Validation Kits available for both conventional endpoint PCR and real-time PCR (qPCR) cyclers False negative PCR results are highly critical and might be caused by a defect PCR cycler. Verification of the correct temperature control of the used equipment is usually a stressful issue. To comply with quality management systems is not easy to fulfill for PCR cyclers.

Principle

The Traditional/qPCR Thermal Cycler Validation Kits provide temperature sensitive PCR reactions to monitor an upper and lower temperature range in one run. The primer sequences in the Traditional Thermal Cycler Validiation Kit respectively the primer/probe sequences in the qPCR Thermal Cycler Validation Kit in combination with a regular PCR protocol were designed to react extremely sensitive to incorrect temperature control, temperature homogeneity, precision and timing. Amplification will completely drop out at temperature differences of more than 2 °C. The cycler performance is tested at standard PCR settings to reflect most users applications. In addition, the pre-adjusted target concentrations are only amplified at high PCR efficiencies as an additional indicator for accurate temperature control of the thermal cycler.

Benefits

  • No extra equipment, instrument or software needed.
  • Applicable with any block PCR cycler or qPCR cycler used in a research or industrial quality assurance lab for the reliability testing of instrument performance and reliability.
  • In the qPCR Thermal Cycler Validiation Kit the probes of each amplification system are labeled with different fluorescent dyes (FAM™ and ROX™) to allow individual evaluation of each temperature range.
  • Includes all you need: Freeze-dried primer/probe sets, polymerase, nucleotides and rehydration buffer

Cat.-No. 57-2102
Traditional Thermal Cylcer Validation Kit (6 strips, 8 vials each)

Cat.-No. 57-2103
Traditional Thermal Cylcer Validation Kit (100 reactions)

PCR Thermal Cycler Color Compensation Kit

For real-time PCR (qPCR) thermal cyclers with optical unit equipped with filter sets for FAM™ and ROX™

Description

As real-time qPCR cyclers may vary in their fluorescence detection sensitivity, color compensation experiments must be performed on each specific multiplex PCR instrument. The Color Compensation Kit is designed for generating color compensation files on qPCR cyclers to allow proper interpretation of multiplex experiments. To generate a color compensation object, the labeled calibration dyes are used in an initial color compensation run. The calibration dyes contain labeled oligonucleotides for the determination of crosstalk corresponding to each individual dye being used in a multiplex assay, and a blank reaction buffer without dye for the determination of background fluorescence of the buffer. The result evaluation is performed by measuring the fluorescence signal with your qPCR cycler.

Kit Components

  • Freeze-dried calibration dyes for 3 different wavelengths (FAM, ROX and VIC)
  • Rehydration Buffer

Cat.-No. 57-0010
10 calibrations (25 μl each)

Detection, Prevention & Elimination of Contamination in Cell Cultures + PCR cycler validation

Minerva Biolabs GmbH is a leading biotechnology company for the development and marketing of detection & elimination kits for the control of microbial contamination. The company is based in Berlin. Their core competence lies in the control of mycoplasma, bacteria and viruses in cell cultures and biopharmaceuticals. In addition they employ their specialized kits and reagents as PCR diagnostics of respiratory tract infections and for the detection of legionella in water. They regard it as their function to be your highly competent expert in these specialized areas of contamination control, clinical diagnostics and water diagnostics.


The Mycoplasma Detection Kits employ PCR technology for rapid and reliable detection of more
than 110 Mollicutes species, including Mycoplasma, Acholeplasma and Spiroplasma. All relevant
species known as contaminants in various in situ biologicals including cell cultures, culture media, cell
preparations and virus stocks are detectable. One of the different types will fit each individual customer’s
need for a fast, reliable and time-saving routine monitoring!
Mynox® is a biological agent that integrates selectively into the mycoplasma membrane
and compromises its integrity. The result is an osmotic influx that leads to the complete
disintegration of the mycoplasma membrane. With mycoplasma eradicated, cells can
immediately return to their native morphology and normal proliferation rates.


Onar® Bacteria utilizes the polymerase chain reaction (PCR) for highly sensitive detection of
bacterial contamination in various in situ biologicals including cell cultures and virus stocks.
The primer set is specific to a highly conserved region within the 16S ribosomal RNA gene in
the bacteria genome. This allows for detection of all bacteria species tested thus far and usually
encountered as airborne contaminants in cell cultures. Eukaryotic DNA is not amplified by
Onar® Bacteria. The Primer/Nucleotide Reaction Mix already provides an Internal Control DNA as an
essential tool for successfully executed reactions.


ZellShield® protects cell cultures from a broad range of common contaminants.
ZellShield® is active against most intracellular and extracellular growing gram negative and gram
positive bacteria, mycoplasma, protozoon, fungi and yeast.
WaterShield™ protects the water in the reservoir from microbial growth. WaterShield™ can be used in
any kind of laboratory water reservoirs and is compatible with common work surfaces.
Mycoplasma-Off™ is a highly effective solution for cleansing and disinfection of all suitable laboratory
surfaces and apparatus. Mycoplasma-Off™ is outstandingly safe in use possessing not only a
strong mycoplasmacidal effect, but also being effective against bacteria, yeasts and viruses: Mycoplasma-
Off™ has been proven to be effective against bacteria such as Staphylococcus aureus,
Enterococcus hirae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Candida albicans,
BVDV, Poliovirus, Adenovirus, Polyomavirus SV40, Norovirus and Vacciniavirus.


The PCR Cycler Check™ kits allow a realistic verification of block and air heated PCR cyclers for installation
qualification (IQ), operational qualification (OQ) and performance qualification (PQ) according
to legal requirements, like ISO 17025, EN 45001, ISO 13485, ISO/TS 20836:2007, GLP, GMP and
others.
The PCR Cycler Check™ series provides temperature sensitive PCR reactions to monitor an upper and
lower temperature range in one PCR reaction. The primer sequences and the PCR protocol were designed
to react extremely sensitive on fluctuations of more than 2 °C within the cycler protocol with a drop
out of amplification. This way the temperature homogeneity, the precision of the temperature control
and the timing can be verified. In addition, the pre-adjusted target concentrations are only amplified at
high PCR efficiencies as an additional indicator for accurate temperature control of the thermal cycler.


AquaScreen® is a test system for quantitative detection of water pathogens. AquaScreen® combines
water filtration, lysis of the collected microorganisms, DNA extraction and elution of the DNA in minimal
volumes ready for subsequent PCR analysis.


Food Control™ kit series includes Food Control™ qPCR, Food Control™ LFA and Food Control™ LFA+
PCR kits for fast and reliable detection of foodborne pathogens via real-time PCR or via our proprietary
Lateral Flow Assay (LFA) technology, respectively. Food Control™ qPCR is a diagnostic system for easy
determination of contamination degree in agricultural or food industry via real-time PCR. LFA technology
provides stripes as an easy read-out making DNA gels obsolete and in combination with our LFA+
cartridges and pre-cast chambers provide maximum contamination prevention. Food Control™ kits can
be combined with our optimized DNA extraction system ExtractNow™ Food Control.


We offer our highly effective decontamination products WaterShield™, Lab Clean™, PCR Clean™ and
PCR Clean™ Wipes in order to help you to protect your research. Watershield™ is a disinfection additive
for incubators and water baths and is active against a broad range of typical water contaminations from
bacteria, mycoplasma, protozoan, algae, fungi and yeast. Water exchange is conveniently indicated by
a diminishing blue stain. Lab Clean™ is a large area decontamination solution useful for floors preventing
room-to-room spreading of e.g. DNA carry over or trace amounts of DNA, keeping your lab “DNAload”
low if regularly applied. Finally, protect your PCR experiments from e.g. carry over or DNases and
RNases using PCR Clean™ or PCR Clean™ Wipes highly effective surface decontamination reagents.

Internal Control

CTR-CPE is a universal Internal Control suitable for all ELITe MGB & Alert Q-PCR kits. The Internal Control is validated for DNA and RNA extraction from non-cellular and cellular biological samples with the ELITechGroup products: EXTRAgen, EXTRAzol, EXTRAblood, ELITe STAR 200 Extraction kit, ELITe GALAXY 300 Extraction Kit, ELITe InGenius SP200 and also with NucliSENS® easyMAG® Reagents (bioMérieux), QIAsymphony® DSP Virus / Pathogen Midi kit and QIAsymphony® DNA Mini kit (QIAGEN).

CTR-CPE is a stabilised plasmid solution containing two plasmid DNAs and genomic RNA of MS2 phage, aliquoted in four tubes and ready for use.

The amplification of the internal control CTR-CPE indicates the correctness of the extraction procedure: the presence of DNA/RNA and the absence of inhibitors.

CE-IVD product

Electrophoresis

ELITechGroup Molecular Diagnostics offers systems for the detection and identification of DNA (derived from nucleic acid amplification) by electrophoretic separation on agarose gel. The product intended use is to detect the DNA amplicons obtained by qualitative nucleic acids amplification assays.

The kit provides ready to use agarose gels in TAE buffer 1x with ethidium bromide, an electrophoresis buffer 50x to be reconstituted with sterile bidistilled water, a loading buffer 6x to prepare the amplification reaction, a ready to use molecular weight standard and a solution of ethidium bromide to dye the gel.

ELITe MGB® Kits – Microbiology

ELITe MGB® Real-Time PCR

ELITech Molecular Diagnostics offers a wide range of Real-Time PCR kits for treatment and monitoring of opportunistic infections and infectious diseases. These products are based on ELITech Molecular Diagnostics proprietary Real-Time PCR technologies that offer significant advantages over traditional methods including:

  • Shorter, optimized probe design for improved discrimination
  • Minimized background signal interference for enhance result integrity
  • Melt-Curve capability to increase specificity and detect genetic variants
  • Superior sensitivity and specificity

This patented technology significantly enhances Real-Time PCR performances, giving clinicians the tools to make better medical decisions and improve clinical outcomes.
All the ELITe MGB kits have a common temperature amplification profile allowing multi target runs on the same instrument at the same time to streamline operations and enhance daily workflow.

ELITe MGB® is registered as an ELITech trademark

CE-IVD assays

Molecular Controls

Molecular Controls & QCMD Past Panels

Qnostics’ Molecular ‘Q’ Controls are positive run controls intended to help laboratories monitor their molecular diagnostic assay on a run to run basis within customer derived limits.

Product Code(s)

ADVQC01
Product: ‘Q’ Control
Pathogen: Adenovirus

ADVMQP01
Product: Molecular ‘Q’ Panel
Pathogen: Adenovirus

BKVQC01
Product: ‘Q’ Control
Pathogen: BK Virus

BKVMQP01
Product: Molecular ‘Q’ Panel
Pathogen: BK Virus

CMVQC01
Product: ‘Q’ Control
Pathogen: Cytomegalovirus

CMVMQP01
Product: Molecular ‘Q’ Panel
Pathogen: Cytomegalovirus

EBVQC01
Product: ‘Q’ Control
Pathogen: Epstein-Barr Virus

EBVMQP01
Product: Molecular ‘Q’ Panel
Pathogen: Epstein-Barr Virus

HHV6QC01
Product: ‘Q’ Control
Pathogen: Human Herpes Virus 6

HHV6MQP01
Product: Molecular ‘Q’ Panel
Pathogen: Human Herpes Virus 6

HSV1QC01
Product: ‘Q’ Control
Pathogen: Human Herpes Virus 1

HSV1MQP01
Product: Molecular ‘Q’ Panel
Pathogen: Human Herpes Virus 1

HSV2QC01
Product: ‘Q’ Control
Pathogen: Human Herpes Virus 2

HSV2MQP01
Product: Molecular ‘Q’ Panel
Pathogen: Human Herpes Virus 2

INFAQC01
Product: ‘Q’ Control
Pathogen: Influenza A Virus

INFBQC01
Product: ‘Q’ Control
Pathogen: Influenza B Virus

RSVQC01
Product: ‘Q’ Control
Pathogen: Respiratory Syncytial Virus

JCVQC02
Product: ‘Q’ Control
Pathogen: JC Virus

JCVMQP02
Product: Molecular ‘Q’ Panel
Pathogen: JC Virus

PINFQC01
Product: ‘Q’ Control
Pathogen: Parainfluenza Virus

VZVQC01
Product: ‘Q’ Control
Pathogen: Varicella Zoster Virus

VZVMQP01
Product: Molecular ‘Q’ Panel
Pathogen: Varicella Zoster Virus

QCMD Past EQA/PT Panels

External Quality Assessment (EQA) / Proficiency Testing (PT) is recognized within ISO15189:2012 as an essential part of a laboratory’s quality management. It helps monitor and improve quality within the laboratory

  • Adenovirus
  • Aspergillus
  • B19
  • Borrelia burgdorferi
  • BK virus
  • Bordetella pertussis
  • Candida albicans
  • Chlamydia trachomatis A
  • Chlamydia trachomatis B
  • Chlamydophila pneumoniae & Mycoplasma pneumoniae
  • Clostridium difficile
  • Cytomegalovirus Dried Blood Spot
  • Cytomegalovirus Whole Blood
  • Cytomegalovirus
  • Coronavirus
  • Dengue Virus
  • Enterovirus
  • Epstein Barr virus
  • ENVA HIV Drug Resistance
  • ENVA HIV Drug Resistance Typing (Integrase)
  • Extended Spectrum β-lactamase and Carbapenemase
  • Viral Gastroenteritis
  • Bacterial Gastroenteritis
  • Parasitic Gastroenteritis
  • Hepatitis A virus
  • Hepatitis B virus
  • Hepatitis B virus Drug Resistance
  • Hepatitis B virus Genotype
  • Hepatitis C virus
  • Hepatitis C virus Genotype
  • Hepatitis C virus Drug Resistance
  • Hepatitis E virus
  • Human Immunodeficiency Virus DNA B
  • Human Immunodeficiency Virus RNA A
  • Human Immunodeficiency Virus RNA B
  • Herpes Simplex Virus
  • Human Papillomavirus
  • Human Herpes virus 6
  • Influenza virus A and B
  • Influenza Haemaglutinin typing
  • JC virus
  • JC virus and BK virus
  • Legionella pneumophila
  • MALDI-TOF Bacterial
  • Metapneumovirus
  • Methicillin Resistant S. aureus
  • Methicillin Resistant S. aureus SPA
  • Methicillin Resistant S. aureus Typing
  • Mycobacterium tuberculosis
  • Neisseria gonorrhoeae
  • Norovirus
  • Parechovirus RNA
  • Parainfluenzavirus
  • Respiratory Syncytial virus
  • Rhinovirus
  • Toxoplasma gondii
  • Vancomycin Resistant Enterococci
  • Varicella-Zoster virus
  • West Nile virus