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Immunocard® C. difficile GDH

A rapid, sensitive enzyme immunoassay for the detection of Clostridium difficile antigen (GDH) in stool specimens.

Catalog Number: 716050

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Definitive answers, confidence in results

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FAQs

Colonization is more common than C. diff infection. The patient exhibits NO clinical symptoms (asymptomatic) but may test positive for the C.diff organism or its toxin gene. With infection, the patient exhibits clinical symptoms and tests positive for the C.diff organism and/or its toxin.

Use a stool toxin test as part of a multistep algorithm (ie, glutamate dehydrogenase [GDH] plus toxin; GDH plus toxin, arbitrated by nucleic acid amplification test [NAAT]; or NAAT plus toxin) rather than a NAAT alone for all specimens received in the clinical laboratory when there are no pre-agreed institutional criteria for patient stool submission.

Use a NAAT alone or a multi-step algorithm for testing (ie, GDH plus toxin; GDH plus toxin, arbitrated by NAAT; or NAAT plus toxin) rather than a toxin test alone when there are pre-agreed institutional criteria for patient stool submission.

There is insufficient data to recommend use of biologic markers as an adjunct to diagnosis.

The 2018 MDRO/CDI Protocol states that the results of the final test that are placed in the patient’s medical record should be used to determine whether or not the event meets the CDI LabID Event definition. That means that facilities using a multi-step testing algorithm for C. difficile will be entering LabID events in NHSN based on the results of the final test in the algorithm.

In 2017, the CDI testing algorithm of “NAAT plus EIA, if NAAT-positive” received the “NAAT” level of risk adjustment.  Now the CDI testing algorithm of “NAAT plus EIA, if NAAt-positive” is assigned the “EIA” level of risk adjustment. Facilities using this algorithm should only enter CDI LabID events into NHSN if the results from the EIA test are positive.

Immunocard® C. difficile GDH – 87449

Para-Pak

The Para-Pak system provides a standardized procedure for the routine collection, transport, preservation, and culture of stool specimens for bacterial enteric pathogens. Learn More.

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“For our CGI lab diagnosis, we selected ImmunoCard® GDH as an initial screen -- given its high NPV -- followed by Alethia, as our routine method of choice. The fast results enable us to report back to the clinician very quickly so that both therapeutic and patient isolation/no-isolation decisions can be made appropriately. Prior to bringing on ImmunoCard GDH and Alethia, we deployed QCC + PCR, and before that, VIDAS A + B was used. Alethia has proven to be superior in turnaround time and accuracy compared to both of the previous approaches.”

Dr. JM Senterre

CHR Citadelle Liege, Belgium

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