30525C / 30550C / T30525C / T30550C -
C. DIFF QUIK CHEK COMPLETE®
The
C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme
immunoassay for the simultaneous detection of Clostridium difficile
glutamate dehydrogenase antigen and toxins A and B in a single reaction
well. The test detects C. difficile antigen, glutamate
dehydrogenase, as a screen for the presence of C. difficile and
confirms the presence of toxigenic C. difficile by detecting toxins
A and B in fecal specimens from persons suspected of
having C. difficile
disease. The test is to be used as an aid in the diagnosis of C.
difficile disease. As with other
C. difficile tests, results
should be considered in conjunction with the patient history.
The sample is added to a tube containing a mixture of Diluent and Conjugate. The diluted sample-conjugate mixture is added to the Sample Well and the device is allowed to incubate at room temperature for 15 minutes. During the incubation, any glutamate dehydrogenase and toxins A and B in the sample bind to the antibody-peroxidase conjugates. The antigen-antibody-conjugate complexes migrate through a filter pad to a membrane where they are captured by the immobilized glutamate dehydrogenase-specific and toxins A and B-specific antibodies in the lines. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After a 10 minute incubation period, the antigen reaction is examined visually for the appearance of a vertical blue line on the “Ag” side of the Reaction Window. A blue line indicates a positive test. If the antigen reaction is positive, then the toxin reaction should be examined visually for the appearance of a blue line on the “Tox” side of the Reaction Window. A blue line indicates a positive test. A positive “C” reaction, indicated by a vertical dotted blue line under the “C” portion of the Reaction Window, confirms that the test is working properly and the results are valid.
Results are shown by the following indicators:
- The formation of a blue line at the left (Ag) side of the
Reaction Window indicates the presence
of glutamate dehydrogenase. - The formation of a blue line at the left (Ag) side and the right (Tox) side of the Reaction Window indicates the presence of glutamate dehydrogenase and C. difficile toxin.
Features
- Patented and patent pending technology
- Results in approximately 30 minutes
- Easy to interpret
- Highly sensitive and specific
Further Information
Package Insert - U.S. only, Issued
11/11
Package Insert - International version, Issued
11/10
CPT Codes Issued 2/12
Material Safety Data Sheet Issued 10/11
Tutorial
C. DIFF QUIK CHEK COMPLETE® [Macromedia Flash Player Required]
A step by step animated guide to detecting C. difficile
presence in fecal specimens
using the C. DIFF QUIK CHEK COMPLETE®
test.
Poster Presentation
Glutamate dehydrogenase (GDH) is Highly Conserved Among Clostridium difficile Ribotypes
American Society of Microbiology meeting, May 2011, New Orleans, LA.
Poster Presentation
Prevalence of Clostridium difficile in Fecal Samples from Inpatient and Outpatient Populations
American Society of Microbiology meeting, May 2011, New Orleans, LA.
Poster Presentation
A New Rapid Combination Test for
Clostridium difficile Antigen and Toxins A and B in Feces –
Evaluation of the C. DIFF QUIK CHEK COMPLETE®
American Society for Microbiology meeting, May 2009, Philadelphia, PA
Poster Presentation
Comparison of the
C. DIFF QUIK CHEK COMPLETE®, a Rapid Combination Test
for Clostridium difficile GDH Antigen and Toxins A and B in Feces with Bacterial Culture
and Cytotoxin Assay
American Society for Microbiology meeting, May 2009, Philadelphia, PA
Poster Presentation
Clinical Evaluation of a New Enzyme Immunoassay (C. DIFF QUIK CHEK COMPLETE®)
for the Rapid and Simultaneous Detection of Clostridium-Glutamate Dehydrogenase
and C. difficile Toxin A/B
American Society for Microbiology meeting, May 2009, Philadelphia, PA