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VIDAS® C. difficile GDH (GDH) is an automated test based on the Enzyme Linked Fluorescent Assay technique (ELFA), for use on the VIDAS family instruments. The VIDAS C. difficile GDH (glutamate dehydrogenase) assay is a qualitative test that detects the C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile in fecal specimens from persons suspected of having C. difficile infection (CDI). The test does not distinguish toxigenic from non-toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. difficile infection. As with other C. difficile tests, results should be considered in conjunction with the patient history.

The VIDAS® C. difficile GDH assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device. Reagents for the assay are ready-to-use and are pre-dispensed in the sealed reagent strips. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. Each step is followed by a wash cycle which eliminates unbound components. Specific binding of GDH present in the sample with mouse monoclonal anti-GDH antibody coated on the interior of the SPR. Binding between GDH and mouse monoclonal anti-GDH antibody conjugated with alkaline phosphatase (ALP). Detection: alkaline phosphatase catalyzes the hydrolysis of the substrate (4-Methylumbellifery! phosphate) into a fluorescent product (4-Methy-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence increases according to the quantity of GDH in the sample. When the VIDAS C. difficile GDH test is completed, the results are analyzed automatically by the instrument, a test value is generated, and a result is printed for each sample.

ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

ImmunoCord C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase (GDH), in fecal specimens from persons suspected of having C. difficile infection. The assay consists of ImmunoCard C. difficile GDH Test Cards containing immobilized polyclonal anti-C. difficile GDH antibodies, ImmunoCard C. difficile GDH Positive Control, ImmunoCard C. difficile GDH Sample Diluent/Negative Control, ImmunoCard C. difficile GDH Enzyme Conjugate, ImmunoCard Wash Buffer I, and ImmunoCard Substrate I.

Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). The assay consists of Premier C. difficile GDH Microwells coated with polyclonal antibodies specific to C. difficile GDH, Premier C. difficile GDH Enzyme Conjugate, Premier 20X Wash Buffer II, Premier Substrate I, Premier Stop Solution I, Premier C. difficile GDH Sample Diluent/Negative Control, and Premier C. difficile GDH Positive Control.

The C. DIFF QUIK CHEK™ test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, 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. FOR IN VITRO DIAGNOSTIC USE.

The C. DIFF QUIK CHEK™ test uses antibodies specific for glutamate dehydrogenase (GDH) of C. difficile. The device contains a Reaction Window with two lines of immobilized antibodies. The test line ("T") contains antibodies against C. difficile GDH. The other, representing a control line ("C"), contains anti-IgG antibodies. The Conjugate consists of antibody to GDH coupled to horseradish peroxidase. To perform the test, the fecal specimen is diluted with Diluent, and Conjugate is added to the diluted sample. 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 GDH in the sample binds to antibodyperoxidase conjugate. The antigen-antibody complexes migrate through a filter pad to a membrane where they are captured by the immobilized anti-GDH antibody in the line. The Reaction Window is subsequently washed with Wash Buffer, followed by the addition of Substrate. After up to a 10-minute incubation, the "T" reaction is examined visually for the appearance of a blue line indicates a positive test. A positive "C" reaction, indicated by a blue line, confirms that sample and all reagents were added in proper sequence and volume, that reagents were active at the time of performing the assay, and that proper sample migration occurred.

The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.

The Triage® C. difficile test is an enzyme immunoassay.