ibs-smart is a blood test that detects validated IBS biomarkers, anti-CdtB and anti-vinculin.
These markers are known to be elevated in a majority of patients with IBS-D or IBS-M and indicate the cause was gastroenteritis.
A 2,500+ patient study conducted at Cedars-Sinai validated anti-CdtB and anti-vinculin as highly specific biomarkers for IBS.
An assessment of these biomarkers in IBS subtypes showed that they have broad applicability in diagnosing patients with IBS-D or IBS-M (IBS with a diarrheal component).
The American College of Gastroenterology's Clinical Guidelines for the Management of IBS suggest "a positive diagnostic strategy as compared to a diagnostic strategy of exclusion...to improve time to initiate appropriate therapy....and to improve cost-effectiveness."
Diagnosing IBS with ibs-smart.
Dr. Mark Pimentel explains:
• Validated IBS biomarkers provide a diagnosis of inclusion.
• Antibody blood testing offers an organic confirmation of an IBS diagnosis.
• A positive result indicates the root cause of the patient's IBS was an instance of infectious gastroenteritis.
Food Poisoning to IBS
All common bacteria that cause food poisoning release Cytolethal Distending Toxin B (CdtB).
Anti-CdtB antibodies are generated to target the toxin. Because of molecular mimicry, anti-vinculin is produced.
Anti-vinculin attacks an important protein in the gut, leading to nerve damage and dysmotility.
IBS-D or IBS-M
The result is IBS with a diarrheal component. Symptoms include abdominal pain, bloating, and diarrhea.
With ibs-smart, you can rule in IBS using a blood test and determine the original cause.
Used early in your diagnostic protocol, ibs-smart can help you focus diagnostic workups.
ibs-smart is a second-generation test and is the only licensed, patented antibody blood test for IBS. The validation study established that a positive result indicated IBS with a positive predictive value up to 100% and specificity up to 94%.
Where Does ibs-smart Fit In a Diagnostic Protocol?
Dr. Mark Pimentel explains:
ibs-smart is an effective complement to your current diagnostic protocol.
As a first-in-line test, ibs-smart helps focus diagnostic work-ups and speeds up the assessment of undiagnosed patients with diarrheal symptoms.
The test offers the fastest path to an IBS diagnosis, which can help you begin treatment for your patients more quickly.
Clear Lab Results
If either antibody is "Elevated," the test results can be considered positive and the patient can be confidently diagnosed with IBS-D or IBS-M.
If both antibodies are "Not Elevated," the test results can be considered non-indicative of post-infectious IBS. Further testing may be required in this case.
ibs-smart is a Laboratory Developed Test, conducted at a CLIA-Certified Partner. PacificDx
ibs-smart Results Interpretation Guide
Patients to Consider
Have IBS symptoms with a diarrheal component
Have no alarm symptoms (e.g., blood in stool)
May or may not remember having had food poisoning
May have factors that increase risks associated with invasive procedures
ibs-smart has broad applicability to patients with diarrheal symptoms. Up to 60% of patients with diarrheal IBS symptoms could be suffering from post-infectious IBS.
Priced for Accessibility
Maximum Patient Responsibility: $220
ibs-smart is covered at least in part by many common insurance plans, including Medicare and Medicaid
PLA Code: 0164U
A published cost minimization model showed a test like ibs-smart could save a health system up to $800 per patient by preventing potentially unnecessary procedures.