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Merck

Real-Time PCR Analysis with IMS Technology

to Improve Your Pathogen Testing Sensitivity & Reliability
with the Assurance® GDS system


ADVANCE YOUR FOOD PATHOGEN PCR ANALYSIS

PCR is widely used to identify and detect pathogens in food samples. However, the reliability of PCR-based pathogen screening methods can be affected by background contamination, false positive-negative results, and lower assay sensitivity and specificity. 

Upgrade your food pathogen detection workflow with the Assurance® GDS system – offering solutions for your pathogen testing needs, ensuring valid subsequent PCR even for the most difficult food sample matrices.

The Assurance® GDS uses the innovative PickPen® and immunomagnetic separation (IMS) technology for pathogen enrichment. Magnetic particles in the device are coated with specific antibodies to quickly collect and transfer target DNA from the enriched sample to the amplification tube for PCR analysis.


SIMPLE 3-STEP WORKFLOW WITH THE ASSURANCE® GDS SYSTEM

Reagent Preparation

Reagent Preparation
Dispensing of concentration reagent (IMS Beads), wash solution, and resuspension buffer to plasticware. Transfer of 1 mL of enriched samples to sample wells.

    Immunomagnetic Separation (IMS)

    Immunomagnetic Separation (IMS)
    Capture, wash, and release of IMS beads + target pathogens. Transfer of concentrated samples+beads to amplification tubes with lyophilized PCR pellet containing the primers, probe, etc.

      Real-Time PCR Analysis

      Real-Time PCR Analysis
      Transfer of amplification tubes to the Assurance® GDS Rotor-Gene® thermal cycler for analysis. Negative and presumptive positive results clearly shown via tables and graphics.

        DISCOVER OUR ASSURANCE® GDS SYSTEM

        We’d be more than happy to give you further information about the Assurance® GDS system or to bring it to your lab for a demo.

        Simply fill out and submit the form below.


        KEY FACTORS TO CONSIDER WHEN CHOOSING A PCR METHOD

        To ensure a valid PCR assay for accurate pathogen detection it is important to select the right system that supports your food and beverage testing needs.

        • Ease of use: How easy is it to separate, concentrate and purify the target pathogen?
        • Matrix versatility: Was the sample protocol developed for many strains of interest and matrices?
        • Time to result: Can the system avoid multiple enrichment methods and achieve shorter enrichment times?
        • High performance: Does the system deliver accurate confirmation of presumptive positive results with less inhibition?
        • Validation panel: Is the method validated according to ISO 16140-2 or reference standards (FDA BAM or USDA MLG)?

        WHAT IS A PCR METHOD WITH IMS TECHNOLOGY, HOW DOES IT WORK, AND WHAT ARE ITS BENEFITS?

        To deliver reliable results, our Assurance® GDS system uses immunomagnetic separation (IMS) technology for pathogen enrichment. Magnetic particles thus capture food pathogens quickly and effectively. This method minimizes inhibition from background materials, ensuring a valid PCR reaction for each sample in a single run.

        Key Benefits of Using a PCR Method with IMS Technology:

        • Dead cell management: The proprietary magnetic particles selectively capture the target living organism
        • Lowers inhibition: The IMS device easily isolates the target pathogen from inhibitors, reducing the risk of false positives
        • Single extraction protocol: The sample preparation procedure is optimized to be more practical, efficient and simple to run
        • Increased sensitivity: The concentrated sample improves assay sensitivity allowing for a shorter enrichment

        How Does it Work With the Assurance® GDS System?

        • PickPen® IMS device selectively captures & separates target pathogens from enrichment broth, removing inhibitor agents
        • IMS device concentrates & delivers a higher quantity of DNA – 8 samples at a time, easily and efficiently
        • Each amplification tube contains all PCR reagents in ready-to-use lyophilized pellets, no need for dispensing
        • The system allows for the simultaneous detection of multiple targets within each amplification tube

        KEY FEATURES AND BENEFITS OF THE ASSURANCE® GDS SYSTEM

        • Robust method sensitivity with an optimum and representative sample volume of 1 mL – the increased sample volume allows for shorter enrichment times and faster results
        • Improves accuracy using primers and probes
        • Protocols and workflows are adapted to meet lab needs with flexible breakpoints, that allow pre-distribution of reagents before the assay, and delay prepared sample processing up to 18h
        • Our sample preparation protocol is easy to use by any lab technician
        • Validated detection methodology with ready-to-use media, saving sample preparation time
        • Faster time to result (TTR), same day or next day with automatic result interpretation
        • Harmonized mEHEC® enrichment media for Salmonella, EHEC & STEC
        • Minimizes inhibition with PickPen® IMS technology
        • Methods validated for both screening & colony identification
        • Assay sample preparation can be manual or automated with up to 72 sample throughput
        • Simple workflow with LIMS-compatible software

        AUTOMATION OF ALL OR JUST A PART OF THE SAMPLE PREPARATION

        The cost-efficient Assurance® GDS PipetMax® automation system is designed to meet a lab’s changing needs:

        • Pre-programmed to pipette all Assurance® GDS reagents and perform IMS protocols
        • Reduces labor, allowing technicians to focus on other tasks
        • Modular design accommodates existing high throughput workflows

        MICROBIOLOGICAL METHOD VALIDATIONS

        The PCR assays with the Assurance® GDS system are validated according to ISO 16140-2 and other reference standards (FDA BAM or USDA MLG) for the detection of food pathogens in a variety of matrices and a range of sample sizes including meat, poultry, dairy, RTE meat, produce, seafood, eggs, infant formula, chocolate, and environmental surfaces.

         


        SERVICES

        Method Development Services

        Optimize or simplify your food testing method for easy implementation in routine and cost-effective testing. Experimental study performed in our application laboratory using your samples and microbial strain(s). Assessment of the matrix compatibility following one of the Assurance® GDS protocols:

        • Feasibility Study
        • Method Optimization

        Instrument Services:

        We offer a Total Services plan and Total Coverage plans that can be executed either in our local repair center or at customer site (where available). Preventive maintenance and system verification ensures optimum performance and reliability of your system and increase its lifetime.

        Training Services

        • Ensure your lab team can get the best out of your Assurance® GDS system.
        • Benefit from years of expertise and get your lab staff certified.
        • In-depth training on food testing for a minimum of 2 participants in our regional training center or at your site.

        WHAT ELSE?

        You might still have questions regarding this technology and instrument, so if you want to have a technical discussion with one of our experts, please fill out our form. They will give you more information, data, and also customer testimonials.

        In addition, our team of experts could help to find the most suitable choice for your food pathogen testing needs.


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