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Randomized Controlled Trial
. 2017 Nov;112(11):1728-1735.
doi: 10.1038/ajg.2017.285. Epub 2017 Oct 10.

A Comparison of Fecal Immunochemical and High-Sensitivity Guaiac Tests for Colorectal Cancer Screening

Jean A Shapiro  1 , Janet K Bobo  2 , Timothy R Church  3 , Douglas K Rex  4 , Gary Chovnick  2 , Trevor D Thompson  1 , Ann G Zauber  5 , David Lieberman  6 , Theodore R Levin  7 , Djenaba A Joseph  1 , Marion R Nadel  1
Affiliations
Randomized Controlled Trial

A Comparison of Fecal Immunochemical and High-Sensitivity Guaiac Tests for Colorectal Cancer Screening

Jean A Shapiro et al. Am J Gastroenterol. 2017 Nov.

Abstract

Objectives: Annual testing using either a high-sensitivity guaiac fecal occult blood test (HS-gFOBT) or a fecal immunochemical test (FIT) is recommended for screening average-risk people for colorectal cancer. We compared the performance characteristics of the HS-gFOBT Hemoccult II SENSA and two FITs (InSure FIT and OC FIT-CHEK) for detecting advanced colorectal neoplasia.

Methods: The study included 1,006 asymptomatic patients, aged 50-75 years, who were scheduled to receive a screening colonoscopy at gastroenterology practices in the Minneapolis and Indianapolis metropolitan areas. Each participant was asked to complete all three stool tests before their colonoscopy. Each test's performance characteristics were evaluated using the screening colonoscopic results as the reference standard.

Results: Sensitivity for detecting advanced colorectal neoplasia was highest for InSure FIT (26.3%, 95% confidence interval (CI) 15.9-40.7), followed by OC FIT-CHEK (15.1%, 95% CI 6.7-26.1) and Hemoccult II SENSA (7.4%, 95% CI 1.9-17.0). InSure FIT was statistically significantly more sensitive than both OC FIT-CHEK (absolute difference in sensitivity=11.2%, 95% CI 0.4-24.2) and Hemoccult II SENSA (difference in sensitivity=18.9%, 95% CI 10.2-32.6). Specificities were relatively high for all tests (between 96.8% and 98.6%).

Conclusions: Our results suggest that some FITs are more sensitive than the HS-gFOBT Hemoccult II SENSA, but these results need to be confirmed in larger asymptomatic populations. Comparisons between the FITs examined in this study and other FITs are needed to determine the best tests for population screening.

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Conflict of interest statement

CONFLICT OF INTEREST

Guarantor of the article: Jean A. Shapiro, PhD.

Specific author contributions: Planning the study: Shapiro, Bobo, Church, Rex, Chovnick, Zauber, Lieberman, Levin, Nadel; conducting the study: Shapiro, Bobo, Church, Rex, Chovnick; collecting data: Shapiro, Bobo, Church, Rex, Chovnick; interpreting data and drafting the manuscript: Shapiro, Bobo, Church, Rex, Chovnick, Thompson, Zauber, Lieberman, Levin, Joseph, Nadel. All authors have approved the submitted manuscript.

Financial support: The Division of Cancer Prevention and Control, Centers for Disease Control and Prevention provided financial support for this study through a contract with Battelle Memorial Institute.

Potential competing interests: Dr Rex reported receiving research support from Endochoice and consulting fees from Olympus. No other conflict of interest disclosures were reported.

References

    1. Henley SJ, Singh SD, King J et al. Invasive Cancer Incidence and Survival—United States, 2012. MMWR Morb Mortal Wkly Rep 2015;64:1353–8. - PubMed
    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015; 65:5–29. - PubMed
    1. Levin B, Lieberman DA, McFarland B et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 2008; 134:1570–95. - PubMed
    1. Smith RA, Manassaram-Baptiste D, Brooks D et al. Cancer screening in the United States, 2015: a review of current American cancer society guidelines and current issues in cancer screening. CA Cancer J Clin 2015; 65:30–54. - PubMed
    1. Bibbins-Domingo K, Grossman DC, Curry SJ et al. creening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2016; 315:2564–75. - PubMed

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