Q: What is IBS?

A: Irritable bowel syndrome (IBS) is a chronic bowel problem that is associated with bloating, intermittent abdominal discomfort, and changes in bowel frequency and form. Diarrhea and constipation are common symptoms associated with IBS. Until now, the diagnosis of IBS has typically been a diagnosis of exclusion because IBS symptoms are similar to those seen for celiac disease, Crohn’s disease, ulcerative colitis, and other chronic bowel diseases.

Q: What is the IBSchek™ Test?

A: IBSchek is a simple ELISA*-based blood test that is highly predictive of an IBS diagnosis based on the presence of 2 antibodies—anti-CdtB and anti-vinculin. In a study of more than 2,500 patients conducted in 180 centers around the U.S., IBSchek was found to be more commonly positive in IBS compared to patients with Crohn’s disease, ulcerative colitis, and celiac disease. These results confirmed that IBSchek is the only quick and reliable blood test for the diagnosis of Irritable Bowel Syndrome.
*ELISA=enzyme-linked immunosorbant assay.

Q: How does IBSchek work?

A: IBSchek was developed based on the scientific discovery that Irritable bowel syndrome often results from a previous episode of gastroenteritis. IBSchek tests for the presence of antibodies that were created by alterations in the intestinal microbiota resulting from acute gastroenteritis. It detects levels of an antibody to a toxin from gastroenteritis called CdtB (cytolethal distending toxin B), as well as vinculin, a human protein commonly found in nerves and the lining of the gut. While the test is more specific for anti-CdtB, the anti-vinculin component suggests that Irritable Bowel Syndrome may be an autoimmune disease. The 2 levels enable a differential diagnosis of IBS from Inflammatory Bowel Disease.

Q: Does IBSchek work for IBS associated with constipation and diarrhea?

A: IBSchek has been validated in diagnosing Irritable Bowel Syndrome associated with diarrhea. Studies are underway—and results are expected by year-end—to validate the efficacy in IBS associated with constipation. Studies are also underway to determine the cost savings—both direct and indirect—to the patient and healthcare system from receiving a faster diagnosis.

Q: What does a positive IBSchek mean?

A: This is a very important question. All tests are based on statistics. If your patient’s result is positive, it means there is a high degree of medical certainty that he or she has IBS. Having a high degree of certainty in Irritable Bowel Syndrome diagnosis reduces cost and prevents treatment delays. It keeps patients from having to undergo more invasive and costly exploratory tests, and, more precisely, it directs your next step in caring for your patients.

Q: What if IBSchek is inconclusive?

A: Although IBSchek is highly predictive of an Irritable Bowel Syndrome diagnosis, some patients you suspect have IBS will still have an inconclusive test result. IBSchek tests for a specific mechanism known to cause Irritable Bowel Syndrome. If the result is positive, you know the pathophysiological reason behind your patient’s IBS and can determine the optimal approach to treat quickly and efficiently. However, an inconclusive IBSchek result is simply an indication that additional testing is required to determine the cause of your patient’s symptoms. One option that may be a viable consideration is the Hydrogen/Methane Breath Test (HMBT) for Small Intestinal Bacterial Overgrowth (SIBO). The HMBT can identify an over-colonization of microbes in the small intestine that may be directly contributing to a patient’s symptoms. This allows an accurate, rapid diagnosis of common sources of digestive distress. HMBTs not only offer a patient-friendly alternative to more invasive diagnostic methods, but once the SIBO is identified, an appropriate antibiotic regimen can be prescribed.

Q: What is the turnaround time for test results?

A: When the IBSchek kit arrives at a CDI-affiliated laboratory, the blood will be analyzed within 24 hours. You can receive the results via secure fax to your office, or you can set up an account and receive them via our secured web-based reporting system.

Q: Can medications affect IBSchek results?

A: Yes, some medications can affect the results of an antibody test. It is important to note that if your patient is taking steroids, anti-inflammatory medications, biologic agents, or any other immunosuppressive medications, you may not get a true reading, because these medications may change the level of antibodies in the blood. If a patient with suspected IBS has a negative test and is taking any of these medications, repeat testing could be considered at a time when the patient is no longer taking these medications.

Q: Does a positive IBSchek tell me what treatment to use for my IBS patient?

A: A positive IBSchek confirms that your patient has IBS and that his or her disease is real. IBSchek does not offer insight into which treatment is best for your Irritable Bowel Syndrome patient. However, confidently knowing your patient has IBS allows you to immediately initiate therapy without additional invasive and costly testing. You may want to consider a Hydrogen/Methane Breath Test (HMBT) for Small Intestinal Bacterial Overgrowth (SIBO) to help determine the type of antibiotic therapy to use. Treatment of a patient with methane-positive breath results differs from that of a patient with hydrogen-positive results. Once the SIBO is identified, an appropriate antibiotic regimen can be prescribed for the treatment of Irritable Bowel Syndrome.

Q: Is there a link between IBS and small intestinal bacterial overgrowth?

A: It is now known (based on extensive human and animal research) that acute gastroenteritis leads to IBS. In animal studies, infection with C. jejuni caused small intestinal bacterial overgrowth. C. jejuni infection also leads to the production of the anti-CdtB and anti-vinculin antibodies detected by IBSchek. In the same animal studies, antibody levels were related to the number of infections the animals experienced. However, irrespective of the number of infections with C. jejuni, bacterial overgrowth was more closely related to the antibodies than the number of infections.

Q: Do I need to be a gastroenterologist to order IBSchek?

A: No. Any healthcare provider who has prescribing rights in his or her state or country of residence can order IBSchek.

Contact our Customer Service department with questions, international toll free, at 888-258-5966, or customerservice@commonwealthdx.com