Results indicators

• A blue line at the left (Ag) side of the Reaction Window indicates the presence of glutamate dehydrogenase.
• 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.

Documentation

• Guidelines Brochure
• Sell Sheet
• Package Insert (PDF) International version, Issued 07/16
• CPT Codes (PDF) Issued 08/2018
• Patent #8,343,726

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 (GDH), 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, and the other is the control line.

Results indicators

• 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 side (T) of the Reaction Window.
• If the visible line is located on the side of the cassette labeled “T,” or no lines are visible in the Reaction Window, then the test did not run properly, the results are invalid and the sample should be tested again using a fresh cassette.

Documentation

• Package Insert (PDF) Issued 04/2021
• CPT Codes (PDF) Issued 08/2018
• Patent #8,343,726

C. DIFF QUIK CHEK ® Presentations and Publications

• Glutamate dehydrogenase (GDH) is Highly Conserved Among Clostridium difficile Ribotypes
• American Society of Microbiology meeting, May 2011, New Orleans, LA
• Prevalence of Clostridium difficile in Fecal Samples from Inpatient and Outpatient Populations
• American Society of Microbiology meeting, May 2011, New Orleans, LA
• Glutamate Dehydrogenase is Highly Conserved Among Clostridium difficile Ribotypes
• J. Clin. Microbiol. April 2012 vol. 50 no. 4 1425-1426
• Detection of Clostridium difficile in fecal specimens using a new rapid antigen test, the C. DIFF QUIK CHEK®s
• American Society for Microbiology meeting, May 2006, Orlando, FL
• Multicenter Evaluation of a Rapid Test for Detection of Clostridium difficile in Fecal Specimens
• American Society for Microbiology meeting, May 2006, Orlando, FL
• Two Rapid Tests for Detection of Clostridium difficile in Fecal Specimens
• American Society for Microbiology meeting, June 2005, Atlanta, GA

TOX A/B QUIK CHEK®

The TOX A/B QUIK CHEK® test is a rapid enzyme immunoassay that uses antibodies specific for toxins A and B of C. difficile.

The device contains a Reaction Window with two stripes. One stripe is a test line specific for toxins A and B. The other stripe is the control line.

• Detects C. difficile toxins A and B in fecal specimens

Results should be considered in conjunction with the patient history.

Results indicators

• 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 side (T) of the Reaction Window.

Documentation

• Package Insert (PDF) Issued 06/18
• CPT Codes (PDF) Issued 08/2018

TOX A/B QUIK CHEK® Poster Presentations and Publications

• Comparative Evaluation of Six Commercially Available Assays for the Detection of Clostridium difficile Toxins in Fecal Specimens
• Comparison of the C. difficile TOX A/B QUIK CHEK® with commercial C. difficile A+B ELISAs American Society for Microbiology meeting, May 2006, Orlando, FL
• Comparison of the TOX A/B QUIK CHEK® to tissue culture assay and to a commercial A+B ELISA for the detection of Clostridium difficile toxins in fecal specimens American Society for Microbiology meeting, May 2006, Orlando, FL
• A New Rapid Test for Detecting Clostridium difficile Toxins A and B in Fecal Specimens American Society for Microbiology meeting, June 2005, Atlanta, GA

C. DIFFICILE TOX A/B II™

A second generation rapid ELISA for the detection of Clostridium difficile toxins A and B in fecal specimens.

Clostridium difficile produces two toxins, A and B. Toxin A often is referred to as the enterotoxin and toxin B is referred to as the cytotoxin. Both toxins are detected by the C. DIFFICILE TOX A/B II™ test.

The C. DIFFICILE TOX A/B II™ test is an ELISA and an alternative to tissue culture assay for detecting C. difficile toxin in fecal specimens. The test is completed within one hour, and a rapid format may be used for results within 30 minutes.

• Detects both toxin A and toxin B
• Utilizes highly specific antibodies
• High correlation with tissue culture but much faster

Documentation

• Package Insert (PDF) Issued 3/08
• CPT Codes (PDF) Issued 08/2018

C. DIFFICILE TOX A/B II™ Poster Presentations and Publications

• Prevalence of Clostridium difficile in Fecal Samples from Inpatient and Outpatient Populations
  American Society of Microbiology meeting, May 2011, New Orleans, LA
• Six Rapid Tests for Direct Detection of Clostridium difficile and Its Toxins in Fecal Samples Compared with the Fibroblast Cytotoxicity Assay
  Journal of Clinical Microbiology, February 2003
• Fatal Pseudomembranous Colitis Associated with a Variant Clostridium difficile Strain Not Detected by Toxin A Immunoassay
  Annals of Internal Medicine, September 2001
• Genetic Characterization of Toxin A-Negative, Toxin B-Positive Clostridium difficile Isolates by PCR
  Journal of Clinical Microbiology, August 2000
• Characterization of a Toxin A-Negative, Toxin B-Positive Strain of Clostridium difficile-Associated Diarrhea
  Journal of Clinical Microbiology, July 2000
• Pseudomembranous Colitis Caused by a Toxin A- B+ Strain of Clostridium difficile
  Journal of Clinical Microbiology, April 2000
• An Outbreak of Toxin A Negative, Toxin B Positive Clostridium difficile-Associated Diarrhea in a Canadian Tertiary-Care Hospital
  Canada Communicable Disease Report, April 1999
• Multicenter Evaluation of the Clostridium difficile TOX A/B TEST
  Journal of Clinical Microbiology, January 1998
• Comparative Evaluation of Six Commercially Available Assays for the Detection of Clostridium difficile Toxins in Fecal Specimens
• Performance of TECHLAB^® C. DIFF CHEK™ in Combination with C. DIFFICILE TOX A/B II™, Triage^® C. difficile Panels, and a Cytotoxin Assay for the Diagnosis of C. difficile-Associated Diarrhea (CDAD)
  American Society of Microbiology meeting, May 2004, New Orleans, LA

Documentation

• Package Insert (PDF) Issued 10/2016
• CPT Codes (PDF) Issued 08/2018

C. DIFFICILE TOX-B TEST

A tissue culture assay for the detection of Clostridium difficile toxin B in fecal specimens.

The C. DIFFICILE TOX-B TEST uses a tissue culture format to detect the presence of cytotoxic activity (cell rounding) in fecal specimens and confirms the identification of C. difficile toxin by using specific antitoxin. Reagents in the kit include toxin control, specific antitoxin, Phosphate Buffered Saline, and diluent.

Minimizes repeat testing of specimens containing high toxin levels

Documentation

• Package Insert (PDF) Issued 05/2015
• CPT Codes (PDF) Issued 08/2018