C DIFF QUIK CHEK COMPLETE 25/ BOX Alere 30525C
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.
•Patented and patent pending technology
•Results in under 30 minutes
•Easy to interpret
•Highly sensitive and specific