Affiliation:
1. Laboratory Medicine and Pathology
2. Biomedical Informatics and Medical Education, University of Washington School of Medicine
3. Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Center
4. Division of Gastroenterology, University of Washington School of Medicine
5. Public Health Sciences & Clinical Research Divisions, Fred Hutchinson Cancer Center, Seattle, WA
Abstract
Goals:
We aimed to determine the performance of the OC-Auto Micro 80 fecal immunochemical test (FIT) in an average-risk population receiving care in an integrated, academic-community health system.
Background:
The FIT is the most used colorectal cancer (CRC) screening test worldwide. However, many Food and Drug Administration–cleared FIT products have not been evaluated in clinical settings.
Study:
We performed a retrospective cohort study of patients (50 to 75 y old) in the University of Washington Medicine health care system who were screened for CRC by OC-Auto Micro 80 FIT between March 2016 and September 2021. We used electronic health records to extract patient-level and clinic-level factors, FIT use, colonoscopy, and pathology findings. The primary outcomes were the FIT positivity rate and neoplasms detected at colonoscopy. Secondary outcomes were FIT positivity by sex and safety-net versus non–safety-net clinical settings.
Results:
We identified 39,984 FITs completed by 26,384 patients; 2411 (6.0%) had a positive FIT result (>100 ng/mL of hemoglobin in buffer), and 1246 (51.7%) completed a follow-up colonoscopy. The FIT positive rate was 7.0% in men and 5.2% in women (P <0.01). Among those who completed a colonoscopy after an abnormal FIT result, the positive predictive value for CRC, advanced adenoma, and advanced neoplasia was 3.0%, 20.9%, and 23.9%, respectively.
Conclusions:
In a retrospective analysis of a large heterogeneous population, the OC-Auto Micro 80 FIT for CRC screening demonstrated a positivity rate of 6.0% and a positive predictive value for CRC of 3.0%.
Publisher
Ovid Technologies (Wolters Kluwer Health)