Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program
Journal
Gastroenterology
Journal Volume
147
Journal Issue
6
Pages
1317-1326
Date Issued
2014
Author(s)
Chuang S.-L.
Chen S.L.-S.
Yen A.M.-F.
Chiu S.Y.-H.
Fann J.C.-Y.
Chou C.-K.
Abstract
BACKGROUND & AIMS: We investigated whether 2 quantitative fecal immunochemical tests (FITs) with the same cutoff concentration of fecal hemoglobin perform equivalently in identifying patients with colorectal cancer (CRC).METHODS: A total of 956,005 Taiwanese subjects, 50 to 69 years old, participated in a nationwide CRC screening program to compare results from 2 FITs; 78% were tested using the OC-Sensor (n = 747,076; Eiken Chemical Co, Tokyo, Japan) and 22% were tested using the HM-Jack (n = 208,929; Kyowa Medex Co Ltd, Tokyo, Japan), from 2004 through 2009. The cutoff concentration for a positive finding was 20 μg hemoglobin/g feces, based on a standardized reporting unit system. The tests were compared using short-term and long-term indicators of performance.RESULTS: The OC-Sensor test detected CRC in 0.21% of patients, with a positive predictive value of 6.8%. The HM-Jack test detected CRC in 0.17% of patients, with a positive predictive value of 5.2%. The rate of interval cancer rate was 30.7/100,000 person-years among subjects receiving the OC-Sensor test and 40.6/100,000 person-years among those receiving the HM-Jack test; there was significant difference in test sensitivity (80% vs 68%, P =.005) that was related to the detectability of proximal CRC. After adjusting for differences in city/county, age, sex, ambient temperature, and colonoscopy quality, significant differences were observed between the tests in the positive predictive value for cancer detection (adjusted relative risk = 1.29; 95% confidence interval, 1.14-1.46) and the rates of interval cancer (0.75; 95% confidence interval, 0.62-0.92). Although each test was estimated to reduce CRC mortality by approximately 10%, no significant difference in mortality was observed when the 2 groups were compared.CONCLUSIONS: Different brands of quantitative FITs, even with the same cutoff hemoglobin concentration, perform differently in mass screening. Population-level data should be gathered to verify the credibility of quantitative laboratory findings. ? 2014 AGA Institute.
SDGs
Other Subjects
hemoglobin; hemoglobin; adult; age; aged; Article; cancer diagnosis; cancer localization; cancer mortality; cancer screening; cancer staging; colonoscopy; colorectal cancer; comparative study; diagnostic accuracy; diagnostic test accuracy study; environmental temperature; fecal immunochemical test; feces analysis; female; follow up; hemoglobin determination; histopathology; human; immunoassay analyzer; immunochemistry; major clinical study; male; patient referral; predictive value; risk factor; sensitivity analysis; sex difference; sigmoidoscopy; adenoma; biological model; chemistry; Colorectal Neoplasms; feces; immunochemistry; incidence; Japan; mass screening; middle aged; mortality; occult blood; procedures; sensitivity and specificity; statistics and numerical data; Adenoma; Aged; Colorectal Neoplasms; Feces; Female; Hemoglobins; Humans; Immunochemistry; Incidence; Japan; Male; Mass Screening; Middle Aged; Models, Biological; Occult Blood; Predictive Value of Tests; Referral and Consultation; Risk Factors; Sensitivity and Specificity
Publisher
W.B. Saunders
Type
journal article