COMMENTS Antibody RESULT INTERPRETATION 0

Patient Name
Physician
Patient Number
Physician ID#
Date of Birth
Address
Date of Specimen Collected
City
Date Received
Date Reported
Antibody
State
Reference Range
Zip
Patient Value
Optical Density*
Cytolethal distending toxin B (CdtB)
0-2.8
2.85
Vinculin
0-1.68
1.6
*Optical Density (OD) values are corrected for nonspecific binding and cross-reactivity within the human serum sample.
RESULT INTERPRETATION
1
These results are consistent with the diagnosis of Irritable Bowel Syndrome (IBS)†
These results are inconclusive; further testing suggested
†
A positive IBSchek™ result suggests that there is a >90% specificity for
IBS and that the IBS may be due to previous gastroenteritis.
An inconclusive IBSchek result does not exclude IBS. It might mean that further studies
are needed to rule out other causes for the patient’s gastrointestinal complaints.
COMMENTS
Reference 1. Pimentel M, Morales W, Rezaie A, et al. Development and Validation of a Biomarker for Diarrhea-Predominant Irritable Bowel Syndrome in
Human Subjects. PLOS ONE; May13, 2015: DOI: [online ref] The IBSchek™ test was developed and its performance characteristics determined by
Commonwealth Laboratories, Inc. (“Commonwealth”) It has not been cleared or approved by the U.S. Food and Drug Administration. Performance
characteristics refer to the analytical performance of the test. These standards are guidelines only. The provider should use this data in conjunction with
additional clinical information that is unavailable to Commonwealth to make a clinical diagnosis. Commonwealth is a Clinical Laboratory Improvement
Amendment (CLIA)–certified, independent clinical laboratory and is required under CLIA to ensure the quality and validity of the IBSchek™ test.
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Phone: 1-877-IBS-CHEK (427-2435) | Fax: 1-866-427-2435
CWI15005
F-252 Rev: A