BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS

Inclusion Criteria:

1. Adults or pediatric patients evaluated by a gastroenterological service for
investigation of possible inflammatory intestinal disease or IBS. Patients are
referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea,
altered appetite, weight loss, or anemia.

- IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed
diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based
on endoscopy and confirmed by histology of biopsies taken during endoscopy.

- IBS: Eligible candidate subjects can also include patients who are self-referred
with the relevant constellation of complaints. Eligible subjects will be enrolled
after having a diagnosis of IBS based on the Rome III criteria confirmed by
negative endoscopy including the colon and terminal ileum.

- other GI Disorders: Eligible subjects will be enrolled after having a diagnosis
of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy
results and other appropriate diagnostic studies.

- Healthy Controls: Adults (≥22) with no abdominal complaints and no history of
IBS, IBD or other chronic intestinal disorder, confirmed by medical history and
physical examination at enrolment.

2. Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of
age (pediatric samples).

3. IBD patients whose diagnostic endoscopy occurred within the previous month.

4. Individuals able to understand the study and the tasks required, and who sign the
Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent
(ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).

Exclusion Criteria:

1. Individuals unable or unwilling to provide a stool specimen.

2. Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal
disease

3. Individuals receiving chemotherapy or systemic immunosuppressive drugs.

4. Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or
H2-receptor antagonists.

5. Individuals with previously diagnosed Inflammatory Bowel Disease managed with
immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have
undergone a surgical resection or diversion procedure.

6. Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including
aspirin, on 7 or more days during the 2 weeks before providing the sample.