Gastroenterology

Gastroenterology

Volume 152, Issue 5, April 2017, Pages 1217-1237.e3
Gastroenterology

AGA Section
Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer

https://doi.org/10.1053/j.gastro.2016.08.053Get rights and content

The use of the fecal occult blood test (FOBT) for colorectal cancer (CRC) screening is supported by randomized trials demonstrating effectiveness in cancer prevention and widely recommended by guidelines for this purpose. The fecal immunochemical test (FIT), as a direct measure of human hemoglobin in stool has a number of advantages relative to conventional FOBT and is increasingly used relative to that test. This review summarizes current evidence for FIT in colorectal neoplasia detection and the comparative effectiveness of FIT relative to other commonly used CRC screening modalities. Based on evidence, guidance statements on FIT application were developed and quality metrics for program implementation proposed.

Section snippets

Literature Review

The committee relied on 2 previous systematic reviews of the FIT. The first was developed for the US Preventive Services Task Force,15 and the second addressed the sensitivity of FIT for CRC.16 To update this review, a search strategy similar to that used for the more recent review16 was used to identify high-quality reports published since August 2013 through September 30, 2015. The updated review used the MEDLINE (Ovid) and Cochrane Database Search strategy as outlined by Lee et al16 in their

How sensitive and specific is FIT-based screening for CRC and advanced neoplasia with one-time application?

Several cohort and cross-sectional studies analyzed the single-application test characteristics of FIT for CRC detection with or without a comparative guaiac-based fecal occult blood test (gFOBT), using colonoscopy or at least 2 years of follow-up evaluation as the reference standard19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38 (Table 1). In a meta-analysis of 19 studies in asymptomatic average-risk adults the pooled sensitivity of FIT was 79% (95% confidence

gFOBT vs FIT

Studies using different designs (eg, randomized controlled trial [RCT], cross-sectional) have compared gFOBT and FIT for the detection of neoplasia in screening populations (Table 4).19, 20, 21, 28, 33, 35, 53, 54, 55, 56, 57, 58 Significant variation exists across studies with the specific brands used (both gFOBT and FIT) and outcomes examined. Studies have indicated that FIT is superior to gFOBT in sensitivity for detecting CRC and advanced neoplasia, with comparable or only slightly reduced

Number of samples

The number of FIT samples needed for test completion (eg, from a single bowel movement vs multiple bowel movements across days) is an important consideration for optimizing CRC screening. In a Dutch study, van Roon et al75 examined participation and clinical outcomes with 1 or 2 FITs (OC-Sensor, Eiken Chemical Co, Tokyo, Japan; cut-off value, 10 μg/g). There was no difference in participation, but 2-sample FIT was associated with a higher detection rate of advanced neoplasia (4.1% [95% CI,

Acknowledgments

The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or the Department of Veterans Affairs.

References (120)

  • L.G. van Rossum et al.

    Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population

    Gastroenterology

    (2008)
  • J. Chubak et al.

    Uptake and positive predictive value of fecal occult blood tests: a randomized controlled trial

    Prev Med

    (2013)
  • T. Raginel et al.

    A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening

    Gastroenterology

    (2013)
  • G. Vart et al.

    Comparing participation rates between immunochemical and guaiac faecal occult blood tests: a systematic review and meta-analysis

    Prev Med

    (2012)
  • D.J. Robertson et al.

    Stool testing for colorectal cancer screening

    Gastroenterology

    (2015)
  • N. Segnan et al.

    Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening

    Gastroenterology

    (2007)
  • A. Castells et al.

    Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests

    Clin Gastroenterol Hepatol

    (2014)
  • A.H. van Roon et al.

    Diagnostic yield improves with collection of 2 samples in fecal immunochemical test screening without affecting attendance

    Clin Gastroenterol Hepatol

    (2011)
  • M.C. Wong et al.

    Diagnostic accuracy of a qualitative fecal immunochemical test varies with location of neoplasia but not number of specimens

    Clin Gastroenterol Hepatol

    (2015)
  • L. Guittet et al.

    Colorectal cancer screening: why immunochemical faecal occult blood test performs as well with either one or two samples

    Dig Liver Dis

    (2012)
  • B. Tannous et al.

    Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: implications for clinical practice in hospital and outpatient settings

    Clin Chim Acta

    (2009)
  • J.M. Auge et al.

    Risk stratification for advanced colorectal neoplasia according to fecal hemoglobin concentration in a colorectal cancer screening program

    Gastroenterology

    (2014)
  • J.A. Wilschut et al.

    Cost-effectiveness analysis of a quantitative immunochemical test for colorectal cancer screening

    Gastroenterology

    (2011)
  • B. Levin 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)
  • D. Lieberman et al.

    Standardized colonoscopy reporting and data system: report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable

    Gastrointest Endosc

    (2007)
  • S.J. Winawer et al.

    Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society

    Gastroenterology

    (2006)
  • J.M. Lane et al.

    Interval fecal immunochemical testing in a colonoscopic surveillance program speeds detection of colorectal neoplasia

    Gastroenterology

    (2010)
  • Cancer of the colon and rectum

    CA Cancer J Clin

    (1980)
  • J.S. Mandel et al.

    Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study

    N Engl J Med

    (1993)
  • A. Shaukat et al.

    Long-term mortality after screening for colorectal cancer

    N Engl J Med

    (2013)
  • J.S. Mandel et al.

    The effect of fecal occult-blood screening on the incidence of colorectal cancer

    N Engl J Med

    (2000)
  • R.M. Jaffe et al.

    False-negative stool occult blood tests caused by ingestion of ascorbic acid (vitamin C)

    Ann Intern Med

    (1975)
  • C.L. Songster et al.

    Immunochemical detection of fecal occult blood–the fecal smear punch-disc test: a new non-invasive screening test for colorectal cancer

    Cancer

    (1980)
  • G.H. Barrows et al.

    Immunochemical detection of human blood in feces

    Am J Clin Pathol

    (1978)
  • M. Zorzi et al.

    Impact on colorectal cancer mortality of screening programmes based on the faecal immunochemical test

    Gut

    (2015)
  • H.M. Chiu et al.

    Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program

    Cancer

    (2015)
  • Vital signs: colorectal cancer screening test use–United States, 2012

    MMWR Morb Mortal Wkly Rep

    (2013)
  • G.H. Guyatt et al.

    GRADE: an emerging consensus on rating quality of evidence and strength of recommendations

    BMJ

    (2008)
  • E.P. Whitlock et al.

    Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force

    Ann Intern Med

    (2008)
  • C.G. Fraser et al.

    A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin

    J Natl Cancer Inst

    (2012)
  • J.E. Allison et al.

    Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteristics

    J Natl Cancer Inst

    (2007)
  • J.E. Allison et al.

    A comparison of fecal occult-blood tests for colorectal-cancer screening

    N Engl J Med

    (1996)
  • T.I. Cheng et al.

    Colorectal cancer screening in asymptomaic adults: comparison of colonoscopy, sigmoidoscopy and fecal occult blood tests

    J Formos Med Assoc

    (2002)
  • T.H. Chiang et al.

    Performance of the immunochemical fecal occult blood test in predicting lesions in the lower gastrointestinal tract

    CMAJ

    (2011)
  • H.M. Chiu et al.

    Association between early stage colon neoplasms and false-negative results from the fecal immunochemical test

    Clin Gastroenterol Hepatol

    (2013)
  • T.R. de Wijkerslooth et al.

    Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia

    Am J Gastroenterol

    (2012)
  • M. Itoh et al.

    Estimation of the optimal cut off point in a new immunological faecal occult blood test in a corporate colorectal cancer screening programme

    J Med Screen

    (1996)
  • G.D. Launoy et al.

    Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average-risk population

    Int J Cancer

    (2005)
  • Z. Levi et al.

    A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study

    Int J Cancer

    (2011)
  • Z. Levi et al.

    A quantitative immunochemical fecal occult blood test for colorectal neoplasia

    Ann Intern Med

    (2007)
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    Conflicts of interest This authors discloses the following: David A. Johnson is a clinical investigator for Exact Sciences and Epigenomics. David Lieberman served on scientific advisory Board for Exact Sciences. Douglas K. Rex received consulting fees from Olympus and research support from Endochoice. Douglas J. Robertson is on the scientific advisory board for Medtronic. Tonya Kaltenback served as Consultant for Olympus America. The remaining authors disclose no conflicts.

    This article is being published jointly in Gastroenterology, American Journal of Gastroenterology, and Gastrointestinal Endoscopy.

    Authors share co-first authorship.

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