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

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