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Tests for the differential detection of Glutamate Dehydrogenase (GDH) and C.Difficile toxins A and B

One-step immunochromatographic tests for the differential detection of Glutamate Dehydrogenase (GDH) as well as C. difficile toxins A and B in human faeces

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C. difficile is a bacteria considered to be responsible for approximately 25% of the diarrhoea associated with the consumption of antibiotics. In addition to these symptoms, the disease can lead to other complications (such as pseudomembranous colitis – PMC) that require urgent antibiotic treatment, as they can be life-threatening. In fact, mortality associated with C. difficile can reach up to 30%.

GDH is an enzyme produced in large quantities by C. difficile strains, which makes it an excellent marker for determining infections caused by this micro-organism. In addition, C. difficile can release toxins (A and/or B), which are the main virulence factors responsible for causing clinical symptoms.

In the diagnosis of C. difficile infection, it is recommended to test all samples for GDH antigen if the origin of the diarrhoea is unknown. In case of a positive GDH antigen test, a second test for toxin A and/or B is recommended.

The Simple/Stick GDH, Simple/Stick 2A-Bdiff and Simple GDH-Toxins tests allow this protocol to be followed, either with a single test or with two independent tests.

≤15 minutes

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Complete diagnostic protocol in a single test

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Simple and safe

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Possibility of automated reading

Our products for the differential detection of Glutamate Dehydrogenase (GDH) and C. Difficile toxins A and B

Product
Catalogue No.
Contents
Sample
Promotional Sheet
CE Decl.
Instruct.
Simple/Stick GDH
9.045.020.00.000
Simple 20 tests/kit. Visual or automated reading
Stool
9.045.020.71.000
Simple 20 tests/kit. Visual reading
9.045.005.00.000
Simple 5 tests/kit. Visual or automated reading
Simple/Stick 2A-Bdiff
9.038.020.00.000
Simple 20 tests/kit. Visual or automated reading
Stool
9.038.005.00.000
Simple 5 tests/kit. Visual or automated reading
Simple GDH-Toxins
9.065.020.20.000
Simple 20 tests/kit. Visual reading
Stool
Positive control (GDH-Toxins)
9.065.011.12.000
1 swab/kit
N/A
N/A

The SIMPLE GDH-Toxin test allows to follow the protocol recommended by both the Society for Healthcare Epidemiology of North America (SHEA) and the Infectious Diseases Society of America (IDSA) and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), but using a single test. This allows the clinician to make decisions more quickly and efficiently.

Possibility of automated reading with OPERON immunochromatography strip reader. The interpretation of results on the Simple GDH-Toxins product, as well as on the Simple/Stick GDH and Simple/Stick 2A-Bdiff products, can be done both visually and automated, thus minimising the possibility of error and allowing the results to be recorded.

Products adapted to rapid and urgent point-of-care or PoC diagnostics, with results in maximum 15 minutes, minimal handling and contact with the sample by the professional performing the test and with all components ready for use.

Positive controls are available to the user to validate the results obtained. They can be purchased as a commercially available independent reference.

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Rapid IC POC Test that differentiates C.diff
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    Frequently Asked Questions

    Simple/Stick GDH, Simple/Stick 2A-Bdiff and Simple GDH-Toxins are all qualitative. This means that the test shows a positive or negative result for the detection of both GDH and toxins A and B, but does not quantify the amount of the positive.

    The tests are manufactured with a shelf life of 24 months.

    The Simple/Stick GDH and Simple/Stick 2A-Bdiff tests are available in either Simple format (i.e. cassette included) or Stick format (reaction strips only).

    Depending on the reference, we can find from kits that include 5 tests to kits that include 20.

    Positive controls may be available separately or included in the kit, according to the user’s need.

    The Simple/Stick 2A-Bdiff and Simple GDH-Toxins tests give results within 15 minutes, while the Simple/Stick GDH test gives results within 10 minutes.

    As indicated in the instructions for use, the test was designed for detection of C.difficile in fresh faeces.

    It is recommended to analyse fresh, untreated samples. If they have to be stored for a period of time, they can be kept in the refrigerator (+2-8ºC) for 1 or 2 days. For longer periods, they should be frozen at -20°C, taking into account that some samples lose immunoreactivity after freezing.

    They can be done both visually and automated, through the OPERON Strip Reader.

    No, all products are transported at room temperature, so handling is simple and economical.

    The kits can be stored at room temperature.