T5029 - C. DIFF QUIK CHEK®
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.
Features
- Patent pending technology
- Results in under 30 minutes
- Easy to interpret
- Highly sensitive and specific
Further Information
Package Insert Issued 2/07
CPT Codes Issued 3/08
Material Safety Data Sheet Issued 7/06
Poster Presentation
Use of a Rapid Antigen Test, C. DIFF QUIK CHEK®, as a Screening Test for C. difficile Disease
American Society for Microbiology meeting, May 2007, Toronto, Canada
Poster Presentation
Detection of Clostridium difficile in fecal specimens using a new rapid antigen test, the C. DIFF QUIK CHEK®
American Society for Microbiology meeting, May 2006, Orlando, FL
Poster Presentation
Multicenter Evaluation of a Rapid Test for Detection of Clostridium difficile in Fecal Specimens
American Society for Microbiology meeting, May 2006, Orlando, FL
Poster Presentation
Two Rapid Tests for Detection of Clostridium difficile in Fecal Specimens
American Society for Microbiology meeting, June 2005, Atlanta, GA
Frequently Asked Questions
Q: Only one line is visible after running the test, what does that mean?
A: One visible line could mean two things. If the visible line is located on the side of the cassette labeled "C" (for Control Line), then the test ran properly and no C. difficile toxin was detected in the sample. If the visible line is located on the side of the cassette labeled "T" (for Test Line), then the test DID NOT run properly, the results are invalid and the sample should be tested again using a fresh cassette. Q: No line is visible after running the test, what does that mean?
A: No visible line means that the test DID NOT run properly. The sample should be tested again using a fresh cassette.
Q: The membrane surface appears dry, even though diluted sample has been added. What should I do?
A: After 5 minutes, if the membrane still appears to be dry, up to 100mL (4 drops) of Diluent can be added to the Sample Well to aid in the "wicking" process. An additional 5 minutes of incubation is required for a total of 20 minutes from the addition of sample. If within 5 minutes the additional Diluent is insufficient to cause wetting of the membrane in the Reaction Window, the test is invalid and the sample should be tested again using a fresh cassette.
Q: What is the CPT code for the C. DIFF QUIK CHEK®?
A: According to the 2006 coding, the CPT code is 87324.