Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program

Tsung-Hsien Chiang; Shu-Lin Chuang; Sam Li-Sheng Chen; Han-Mo Chiu; Amy Ming-Fang Yen; Sherry Yueh-Hsia Chiu; Jean Ching-Yuan Fann; Chu-Kuang Chou; Yi-Chia Lee; Ming-Shiang Wu; Hsiu-Hsi Chen

doi:10.1053/j.gastro.2014.08.043

Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program

Gastroenterology. 2014 Dec;147(6):1317-26. doi: 10.1053/j.gastro.2014.08.043. Epub 2014 Sep 6.

Authors

Affiliations

¹ Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Department of Integrated Diagnostics and Therapeutics, National Taiwan University Hospital, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.
² Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
³ School of Oral Hygiene, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.
⁴ Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
⁵ Department and Graduate Institute of Health Care Management, Chang Gung University, Tao-Yuan, Taiwan.
⁶ Department of Health Industry Management, Kainan University, Tao-Yuan, Taiwan.
⁷ Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Division of Gastroenterology and Hepatology, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.
⁸ Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan; Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan. Electronic address: yichialee@ntu.edu.tw.
⁹ Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.

PMID: 25200099
DOI: 10.1053/j.gastro.2014.08.043

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.

Keywords: Colorectal Cancer; Interval Cancer; Population Screening; Screening Test Sensitivity.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adenoma / diagnosis*
Adenoma / epidemiology
Aged
Colorectal Neoplasms / diagnosis*
Colorectal Neoplasms / mortality
Feces / chemistry*
Female
Hemoglobins / analysis*
Humans
Immunochemistry / methods
Immunochemistry / statistics & numerical data
Incidence
Japan / epidemiology
Male
Mass Screening / methods*
Mass Screening / statistics & numerical data
Middle Aged
Models, Biological*
Occult Blood
Predictive Value of Tests
Referral and Consultation / statistics & numerical data
Risk Factors
Sensitivity and Specificity

Substances

Hemoglobins