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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. The device contains a Reaction Window with two stripes; one stripe is a test line specific for GDH, the other stripe is the control line.
The fecal sample is added to Diluent and Conjugate. The mixture is transferred to the Sample Well and the device is incubated for 15 minutes. During this time, any GDH present in the sample binds to the conjugate and the resulting complexes are captured by the antibodies in the test line. The Reaction Window is washed and Substrate is added to read the reaction.
Proper test performance is indicated by the formation of a blue line at the control side (C) of the Reaction Window.
A positive result is indicated by the formation of a blue line at the test (T) side of the Reaction Window.
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