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

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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.

Original languageEnglish
Pages (from-to)1317-1326
Number of pages10
JournalGastroenterology
Volume147
Issue number6
DOIs
Publication statusPublished - Dec 1 2014

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Early Detection of Cancer
Colorectal Neoplasms
Hemoglobins
Tokyo
Japan
Confidence Intervals
Neoplasms
Mass Screening
Mortality
Colonoscopy
Feces
Temperature
Population

Keywords

  • Colorectal Cancer
  • Interval Cancer
  • Population Screening
  • Screening Test Sensitivity

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. / Chiang, Tsung Hsien; Chuang, Shu Lin; Chen, Sam Li Sheng; Chiu, Han Mo; Yen, Amy Ming Fang; Chiu, Sherry Yueh Hsia; Fann, Jean Ching Yuan; Chou, Chu Kuang; Lee, Yi Chia; Wu, Ming Shiang; Chen, Hsiu Hsi.

In: Gastroenterology, Vol. 147, No. 6, 01.12.2014, p. 1317-1326.

Research output: Contribution to journalArticle

Chiang, Tsung Hsien ; Chuang, Shu Lin ; Chen, Sam Li Sheng ; Chiu, Han Mo ; Yen, Amy Ming Fang ; Chiu, Sherry Yueh Hsia ; Fann, Jean Ching Yuan ; Chou, Chu Kuang ; Lee, Yi Chia ; Wu, Ming Shiang ; Chen, Hsiu Hsi. / Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. In: Gastroenterology. 2014 ; Vol. 147, No. 6. pp. 1317-1326.
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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.",
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AU - Chuang, Shu Lin

AU - Chen, Sam Li Sheng

AU - Chiu, Han Mo

AU - Yen, Amy Ming Fang

AU - Chiu, Sherry Yueh Hsia

AU - Fann, Jean Ching Yuan

AU - Chou, Chu Kuang

AU - Lee, Yi Chia

AU - Wu, Ming Shiang

AU - Chen, Hsiu Hsi

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N2 - 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.

AB - 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.

KW - Colorectal Cancer

KW - Interval Cancer

KW - Population Screening

KW - Screening Test Sensitivity

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