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Comparative Evaluation of Immunochemical Fecal Occult Blood Tests for Colorectal Adenoma Detection

Sabrina Hundt, MSc; Ulrike Haug, PhD; and Hermann Brenner, MD, MPH
[+] Article, Author, and Disclosure Information

From The German Cancer Research Center, Heidelberg, Germany.

Acknowledgment: The authors acknowledge Isabel Lerch for her contribution in study coordination and study monitoring.

Grant Support: By the German Research Foundation (Deutsche Forschungsgemeinschaft) within the framework of a PhD program (Graduiertenkolleg 793). Test kits were provided free of charge by the manufacturers.

Potential Financial Conflicts of Interest: None disclosed.

Reproducible Research Statement:Study protocol: Not available. Data set and statistical code: Available by request from and written agreement with Dr. Haug (e-mail, u.haug@dkfz.de).

Requests for Single Reprints: Ulrike Haug, PhD, Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Bergheimer Strasse 20, 69115 Heidelberg, Germany; e-mail, u.haug@dkfz.de.

Current Author Addresses: Ms. Hundt and Drs. Haug and Brenner: Division of Clinical Epidemiology and Aging Research, German Research Center, Bergheimer Strasse 20, 69115 Heidelberg, Germany.

Author Contributions: Conception and design: U. Haug, H. Brenner.

Analysis and interpretation of the data: S. Hundt, U. Haug, H. Brenner.

Drafting of the article: S. Hundt, U. Haug.

Critical revision of the article for important intellectual content: U. Haug, H. Brenner.

Final approval of the article: S. Hundt, U. Haug, H. Brenner.

Statistical expertise: U. Haug, H. Brenner.

Obtaining of funding: H. Brenner.

Administrative, technical, or logistic support: S. Hundt.

Collection and assembly of data: S. Hundt.

Ann Intern Med. 2009;150(3):162-169. doi:10.7326/0003-4819-150-3-200902030-00005
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Background: Different immunochemical fecal occult blood tests (FOBTs) have been proposed for noninvasive colorectal cancer screening. Large-scale, colonoscopy-based screening studies that allow evaluation of these tests for the detection of precursor lesions are scarce.

Objective: To determine and compare performance characteristics of 6 qualitative immunochemical FOBTs for identifying colorectal adenomas among adults who attended screening colonoscopy examinations.

Design: Prospective screening study from January 2006 to December 2007.

Setting: 20 gastroenterology practices in Germany that did screening colonoscopy.

Patients: 1319 participants at average risk for colorectal neoplasia who were undergoing screening colonoscopy (mean age, 63 years; 50% men).

Measurements: 6 different qualitative immunochemical FOBTs were done with stool samples collected before bowel preparation for colonoscopy. Performance characteristics (sensitivity, specificity, predictive values, and likelihood ratios) of tests were measured by comparing test results with findings on colonoscopy. Technicians who read the tests were blinded to colonoscopy results, and colonoscopists were blinded to FOBT results.

Results: Overall, 405 participants (31%) had an adenoma and 130 participants (10%) had an advanced adenoma. Performance characteristics varied widely among tests. For the 2 best-performing tests (immoCARE-C [CAREdiagnostica, Voerde, Germany] and FOB advanced [ulti med, Ahrensburg, Germany]), the sensitivity for detection of advanced adenomas was 25% (95% CI, 18% to 34%) and 27% (CI, 20% to 35%), respectively; specificity was 97% (CI, 95% to 98%) and 93% (CI, 91% to 95%); and the positive likelihood ratio was 3.5 (CI, 2.2 to 5.4) and 2.5 (CI, 1.9 to 3.5).

Limitation: The study differed from real-life conditions in that stool samples were not directly dissolved in a buffer-filled vial; instead, a small container was used and stool was frozen before testing.

Conclusion: Qualitative immunochemical FOBTs could be an option for future colorectal cancer screening because they showed better performance characteristics for precursor lesions than guaiac-based FOBTs and are practical for mass screening. However, given the large differences in diagnostic performance among tests, careful evaluation of the different test variants is important.

Funding: The German Research Foundation (Deutsche Forschungsgemeinschaft) within the framework of a PhD program (Graduiertenkolleg 793).


Grahic Jump Location
Study flow diagram.

FOBadv = FOB advanced (ulti med, Ahrensburg, Germany); FOBplus = Bionexia FOBplus (DIMA, Göttingen, Germany); Hb/Hp C = Bionexia Hb/Hp Complex (DIMA); HO = HemOccult (Beckman Coulter, Krefeld, Germany); immoCare = immoCARE-C (CAREdiagnostica, Voerde, Germany); PreventID CC = PreventID CC (Preventis, Bensheim, Germany); QuickVue = QuickVue iFOB (Quidel, San Diego, California).

* The exclusion of 44 patients overall was due to missing or noninterpretable test cards.

Grahic Jump Location




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Summary for Patients

Immunochemical Fecal Occult Blood Tests

The summary below is from the full report titled “Comparative Evaluation of Immunochemical Fecal Occult Blood Tests for Colorectal Adenoma Detection.” It is in the 3 February 2009 issue of Annals of Internal Medicine (volume 150, pages 162-169). The authors are S. Hundt, U. Haug, and H. Brenner.


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