illumigene C. difficile by Meridian Bioscience

Catalog Number: 280050


Product Description

DNA amplification assay for the detection of Cytotoxigenic C. difficile in Stool Specimens.

The illumigene C. difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection to toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile Paloc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

<strong><em>illumi</strong>gene C. difficile</em> by Meridian Bioscience

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    Product Specification 

    Catalog Number: 280050
    Assay Format: Isothermal Nucleic Acid Amplification Assay
    Kit Size: 50 tests
    Specimen Type: Stool
    Sensitivity: 95.2%
    Specificity: 95.3%
    Time to Results (TAT): <1 hour
    Kit Storage Requirements: 2-27°C
    Shelf Life: 18 months
    Manufacturer: Meridian Bioscience, Inc.
    GMDN: 30714
    EDMA: 15.01.40.02
    CE: YES
    FDA: YES
    Availability: European Union
    Other countries: Please Contact Us or visit our Distributor page.


    Customer Reviews

    "At Wirral University Teaching Hospital NHS Foundation Trust we have considerable experience with the illumigene C difficile DNA molecular assay. In patients who are positive following GDH screening, we undertake toxin testing and simultaneous toxin gene assay. This allows us to identify patients who are toxin-negative, but illumigene-positive, and this information is taken into account when considering the most suitable therapy, and infection prevention & control interventions. The same approach is used for Clatterbridge Cancer Centre, and is valuable in this particularly vulnerable patient population."

    Dr John Cunniffe, Consultant Microbiologist, Wirral University Teaching Hospital NHS Foundation Trust, UK

    "illumigene: when you want to implement into your routine laboratory, why? Well….final result in 1 hour, very fast report to clinicians, it’s easy to perform, hands on time of only 20 minutes, there’s no high proficiency needs, you can train your lab staff very easily."

    "No need for expensive equipment – you just need your heat block and your platform – that’s it. It has a high NPV – also a major advantage”

    Dr. Katelijne Floré, AZ Sint-Lucas Brugge, Belgium

    "Previously our laboratory used QCC from TechLab, Alere as the cornerstone of our Clostridrium difficile routine diagnostic testing. We decided two years ago to switch to the Meridian Bioscience CDIFF ABSOLUTE algorithm, which combines two steps, namely, the ImmunoCard GDH common antigen screen, which screens out negative samples effectively, and the illumigene molecular step which is used to confirm GDH positive stool samples. CDIFF ABSOLUTE has proven itself a more rapid, more cost effective and more efficient algorithmic approach with superior accuracy, compared to QCC in our experience."

    Dr Mulongo, CEBIODO, Brussels, Belgium

    "I have been using Meridian products for 4 years and in the last year, I have adapted to the latest guidelines and I’m using illumigene for the diagnosis of CDI; it provides an accurate and fast diagnosis and yields reliable results because of the high NPV of the system.

    In addition to Meridian, we organized a meeting with the medical department and they themselves have realized the importance of the appropriateness of the sample and the futility of the review of the patient after treatment of C. difficile.

    I can say I am completely satisfied with the change I made."

    Dr. ssa Maurizia Bonezzi, Casa di cura Villa Verde, Reggio Emilia, Italy

    “For our CDI lab diagnosis we selected the CDIFF ABSOLUTE strategy (incorporating ImmunoCard GDH as an initial screen given its high NPV, followed by illumigene) as our routine method of choice. CDIFF ABSOLUTE has been adapted for the lab for the past 2 years.
    This benefits us in a number of ways: very fast assay results, which enables us to report back to the clinician very quickly so that both therapeutic and patient isolation/no-isolation decisions can be made rapidly and appropriately. The illumigene platform is both robust and easy to use, with minimal training requirements and also in comparison to PCR, as no special room conditions are required, the illumigene can be used on weekends and with versatility.
    Previously, we deployed QCC + PCR in the lab and beforehand VIDAS A+B was used, however, from a logistical, turnaround time and accuracy perspective, illumigene has proven itself to be superior to both these approaches.”

    Dr JM Senterre, CHR Citadelle, Liege, BELGIUM

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