Gastroenterology

Gastroenterology

Volume 147, Issue 6, December 2014, Pages 1317-1326
Gastroenterology

Original Research
Full Report: Clinical—Alimentary Tract
Difference in Performance of Fecal Immunochemical Tests With the Same Hemoglobin Cutoff Concentration in a Nationwide Colorectal Cancer Screening Program

https://doi.org/10.1053/j.gastro.2014.08.043Get rights and content
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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.

Keywords

Population Screening
Colorectal Cancer
Screening Test Sensitivity
Interval Cancer

Abbreviations used in this paper

CI
confidence interval
CRC
colorectal cancer
FIT
fecal immunochemical test
ISO
International Organization for Standardization
RR
relative risk
SR
screening rate

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Conflicts of interest The authors disclose no conflicts.

Funding This study was supported by the Health Promotion Administration, Ministry of Health and Welfare (A1011119 and A1021227). The funding source had no role in study design, data collection, analysis, or interpretation, report writing or the decision to submit this paper for publication.

Author names in bold designate shared co-first authorship.