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. All logos and trademarks are the intellectual property of Commonwealth Laboratories, Inc., Salem, MA. ©2015 Commonwealth Laboratories, Inc. | 39 Norman Street Salem, MA 01970 Phone: 1-877-IBS-CHEK (427-2435) | Fax: 1-866-427-2435 CWI15005 F-252 Rev: A