Back to Journals » Clinical Epidemiology » Volume 10

Variation of diagnostic performance of fecal immunochemical testing for hemoglobin by sex and age: results from a large screening cohort

Authors Brenner H, Qian J, Werner S

Received 30 October 2017

Accepted for publication 31 December 2017

Published 5 April 2018 Volume 2018:10 Pages 381—389


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Professor Vera Ehrenstein

Hermann Brenner,1–3 Jing Qian,1 Simone Werner1

1Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany; 2Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany; 3German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg, Germany

Objective: Fecal immunochemical tests (FITs) for hemoglobin in stool are increasingly used for colorectal cancer screening. Reported sensitivities and specificities have strongly varied between studies, but it is unclear to what extent such variation reflects differences between tests or between study population characteristics. We aimed to evaluate the key parameters of FIT performance for detecting advanced neoplasia (AN) according to sex and age.
Methods: Sex- and age-specific sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs) for detecting AN of a quantitative FIT (FOB Gold®) were evaluated among 3211 men and women aged 50–79 years who underwent screening colonoscopy in Germany.
Results: At the cutoff recommended by the manufacturer (17 µg hemoglobin/g feces), sensitivity was higher (51.2% versus 34.7%, p=0.004) and specificity was lower (91.0% versus 94.8%, p<0.001) among 65–79 year-old participants compared with 50–64 year-old participants. PPVs and NPVs did not differ significantly between age groups. However, higher NPVs were observed among women compared with men (94.7% versus 92.5%, p=0.015). Specificity was also higher among women compared with men (94.7% versus 92.3%, p=0.007), while there was only a little variation in sensitivity (40.3% versus 41.8%, p=0.789) according to sex. In joint stratification by both factors, sensitivity ranged from 34.1% (95% CI 24.2%–45.2%) in 50–64 year-old women to 51.4% (95% CI 39.3%–63.3%) in 65–79 year-old men (p=0.029). The observed age and sex differences were highly consistent across a wide range of alternative cutoffs from 10 to 50 µg hemoglobin/g feces.
Conclusion: There are major differences in diagnostic performance parameters according to sex and age, which should receive careful attention in the interpretation and comparison of results of FIT-based colorectal cancer screening studies.

Keywords: colorectal cancer, fecal immunochemical tests, hemoglobin, screening

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]