T5015 - C. DIFFICILE TOX A/B II™
A second generation rapid ELISA for the detection of Clostridium difficile toxins A and B in fecal specimens.
After treatment with antibiotics, many patients develop gastrointestinal problems ranging from mild diarrhea to severe pseudomembranous colitis. Many cases of the milder forms of gastrointestinal illness and most cases of pseudomembranous colitis are caused by Clostridium difficile. This organism is an opportunistic anaerobic bacterium that grows in the intestine once the normal flora has been altered by antibiotics. 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™. The C. DIFFICILE TOX A/B II™ is an ELISA and is an alternative to tissue culture assay for detecting C. difficile toxin in fecal specimens. The test is completed within one hour. Alternatively, a rapid format may be used for results within 30 minutes.
Features
- Detects both toxin A and toxin B
- No indeterminates
- Results in an hour or less
- Easy to perform
- Utilizes highly specific antibodies
- High correlation with tissue culture but much faster
Further Information
Package Insert Issued 3/08
CPT Codes Issued 3/08
Material Safety Data Sheet Issued 3/06
Poster Presentation
Comparative Evaluation of Six Commercially Available Assays for the Detection of Clostridium difficile Toxins in Fecal Specimens
Poster Presentation
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.
Frequently Asked Questions
Q: I'm satisfied with my toxin A EIA but I've heard that our lab should be using a test that detects both toxins. Why?
A: There have been an increasing number of reports of toxin A negative, toxin B positive strains of C. difficile. These strains have caused a number of deaths because hospitals have used a toxin A test that did not detect the infection in time for isolation and treatment of these patients. These unusual strains are lacking the portion of the toxin A gene that contains the code for the region of the toxin A molecule that the antibodies used in the toxin A EIAs recognize.
Q: What is the CPT code for the C. DIFFICILE TOX A/B II™?
A: According to the 2006 coding, the CPT code is 87324.
Q: What is the detection limit for the C. DIFFICILE TOX A/B II™?
A: The C. DIFFICILE TOX A/B II™ test will detect Toxin A at levels > 0.8 ng/mL and Toxin B at levels > 2.5 ng/mL.
Q: How long can I store a fecal sample after it's been diluted in the kit Diluent?
A: Diluted fecal samples can be stored for up to 72 hours between 2° and 8°C.
Q: Can I read the test visually?
A: Yes, the test can be read visually using the color chart found on the back of the instructional card. This guide will enable you to interpret the test results without the aid of a spectrophotometer.
Q: Can I test fecal samples collected from barium enemas or colonic washings?
A: The test was not designed to be used on anything other than diarrheal samples; therefore, we do not have data for these types of samples. If this type of sample is tested, the results reported to the physician should contain a disclaimer.
Q: Can I test solid samples?
A: We do not recommend testing solid samples; however, it is difficult to refuse to test a sample based on its consistency. If the lab decides to run the test be aware that this type of sample may give a false positive if the plate is not washed correctly or too much sample is used in the test. Take special care in plate washing.
Q: Should I test samples from infants?
A: Despite the fact that 50% of infants carry Clostridium difficile as normal flora, we recommend testing if symptoms are present. Clostridium difficile disease is primarily an opportunistic infection in the elderly population, but in some instances, infants can acquire the disease. The physician should be advised about normal carriage rates in this population when the result is reported.
Q: How many times should a patient be tested?
A: The number of times a patient should be tested should be based upon your facility's requirements. However, according to many clinicians, some facilities typically require up to 3 fecal specimens (not more than one per day) tested per patient to confirm a negative result. If the result is positive, further testing 7-10 days after completion of therapy can help to show that toxin is no longer present in the feces.