Skip to main content
SpringerLink
Log in

Quality Indicators and Benchmarks for Guideline-Recommended Fecal Occult Blood Tests

  • Chapter
  • First Online:
Colorectal Cancer Screening

Abstract

The fecal immunochemical test (FIT) for hemoglobin is beginning to be accepted as a legitimate and attractive choice for use as a screening test for colorectal cancer in the USA, but, as yet, many primary care physicians, gastroenterologists, health policy experts, and US laboratory professionals remain unfamiliar with FIT’s usefulness and potential or do not understand why quality standards and benchmarks are critical to FIT effectiveness and for their evaluation. All such stakeholders must understand the need for FIT refinement and standardization to ensure traceability of analytical results, consistency in fecal sample mass evaluation, assessment of hemoglobin (Hb) stability, and common units for reporting Hb concentrations. We hope this chapter will help provide the reader with an understanding of the importance of adopting a standardized approach to FIT nomenclature, to the measurement of fecal Hb (f-Hb) concentrations, and of how FIT results are reported.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Abbreviations

ACP:

American College of Physicians

ACR:

American College of Radiology

ACS:

American Cancer Society

CDC:

Centers for disease control

EWG:

Expert working group

FIT:

Fecal immunochemical test for hemoglobin

FOBT:

Fecal occult tests for blood: Traditional, low analytical sensitivity

FS:

Flexible sigmoidoscopy

gFOBT:

Guaiac fecal occult blood test

sFOBT:

Sensitive guaiac fecal occult blood test

f-Hb:

Fecal hemoglobin concentration

Hb:

Hemoglobin

MSTF:

Multi-society task force

POCT:

Point-of-care test

PPV:

Positive predictive value

WEO:

World Endoscopy Organization

References

  1. Levin B, Lieberman DA, McFarland B, Smith RA, Brooks D, Andrews KS, 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. CA Cancer J Clin. 2008;58(3):130–60. doi:10.3322/ca.2007.0018. (Epub 2008/03/07).

    Article  PubMed  Google Scholar 

  2. Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. preventive services task force. Ann Intern Med. 2008;149(9):638–58. doi:0000605-200811040-00245 [pii].

    Article  PubMed  Google Scholar 

  3. Rex DK, Kahi CJ, Levin B, Smith RA, Bond JH, Brooks D, et al. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US multi-society task force on colorectal cancer. Gastroenterology. 2006;130(6):1865–71.

    Article  PubMed  Google Scholar 

  4. Imperiale TF. Noninvasive screening tests for colorectal cancer. Dig Dis. 2012;30(Suppl 2):16–26. doi:10.1159/000341884. (Epub 2012/12/12).

    Article  PubMed  Google Scholar 

  5. Halloran SP, Launoy G, Zappa M. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First edition faecal occult blood testing. Endoscopy. 2012;44(Suppl 03):SE65–87. doi:10.1055/s-0032-1309791.

    Google Scholar 

  6. Fraser CG, Halloran S, Allison J, Young G. Making colorectal cancer screening FITTER for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT). Clin Chem Lab Med. 2013;51(11):2065–7. doi:10.1515/cclm-2013-0408.

    Article  CAS  PubMed  Google Scholar 

  7. Allison JE, Tekawa IS, Ransom LJ, Adrain AL. A comparison of fecal occult-blood tests for colorectal-cancer screening. N Engl J Med. 1996;334(3):155–9. doi:10.1056/NEJM199601183340304. (Epub 1996/01/18).

    Article  CAS  PubMed  Google Scholar 

  8. Rozen P, Knaani J, Samuel Z. Performance characteristics and comparison of two immunochemical and two guaiac fecal occult blood screening tests for colorectal neoplasia. Dig Dis Sci. 1997;42(10):2064–71. doi:10.1023/a:1018866400973.

    Article  CAS  PubMed  Google Scholar 

  9. Rennert G, Rennert HS, Miron E, Peterburg Y. Population colorectal cancer screening with fecal occult blood test. Cancer Epidemiol Biomarkers Prev. 2001;10(11):1165–8.

    CAS  PubMed  Google Scholar 

  10. Kershenbaum A, Flugelman A, Lejbkowicz F, Arad H, Rennert G. Excellent performance of Hemoccult Sensa in organised colorectal cancer screening. Eur J Cancer. 2013;49(4):923–30. doi:10.1016/j.ejca.2012.09.020. (Epub 2012/10/27).

    Article  PubMed  Google Scholar 

  11. Allison JE, Sakoda LC, Levin TR, Tucker JP, Tekawa IS, Cuff T, et al. Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteristics. J Natl Cancer Inst. 2007;99(19):1462–70. doi:10.1093/jnci/djm150. (Epub 2007/09/27).

    Article  PubMed  Google Scholar 

  12. Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, et al. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008;149(7):441–50, W81. (Epub 2008/10/08).

    Article  PubMed Central  PubMed  Google Scholar 

  13. Smith A, Young GP, Cole SR, Bampton P. Comparison of a brush-sampling fecal immunochemical test for hemoglobin with a sensitive guaiac-based fecal occult blood test in detection of colorectal neoplasia. Cancer. 2006;107(9):2152–9. doi:10.1002/cncr.22230. (Epub 2006/09/26).

    Article  PubMed  Google Scholar 

  14. Allison JE, Meijer GA. Colonic polyps: the harm of overdiagnosis. Practical approaches to the diagnosis and treatment of colorectal cancer, Series 8. Prac Gastroenterol. 2012;XXXVI(11):25–38.

    Google Scholar 

  15. Vart G, Banzi R, Minozzi S. Comparing participation rates between immunochemical and guaiac faecal occult blood tests: a systematic review and meta-analysis. Prev Med. 2012;55(2):87–92. doi:10.1016/j.ypmed.2012.05.006. (Epub 2012/05/29).

    Article  PubMed  Google Scholar 

  16. Cole SR, Young GP, Esterman A, Cadd B, Morcom J. A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen. 2003;10(3):117-22. doi:10.1258/096914103769011003.

    Article  CAS  PubMed  Google Scholar 

  17. Hoffman RM, Steel S, Yee EF, Massie L, Schrader RM, Murata GH. Colorectal cancer screening adherence is higher with fecal immunochemical tests than guaiac-based fecal occult blood tests: a randomized, controlled trial. Prev Med. 2010;50(5–6):297–9. doi:10.1016/j.ypmed.2010.03.010. (Epub 2010/03/24).

    Article  PubMed  Google Scholar 

  18. Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JC, et al. Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut. 2010;59(1):62–8. doi:10.1136/gut.2009.177089. (Epub 2009/08/13).

    Article  CAS  PubMed  Google Scholar 

  19. Hughes K, Leggett B, Del Mar C, Croese J, Fairley S, Masson J, et al. Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community. Aust NZ J Public Health. 2005;29(4):358–64. (Epub 2005/10/15).

    Article  Google Scholar 

  20. van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008;135(1):82–90. doi:10.1053/j.gastro.2008.03.040. (Epub 2008/05/17).

    Article  PubMed  Google Scholar 

  21. Digby J, McDonald PJ, Strachan JA, Libby G, Steele RJ, Fraser CG. Use of a faecal immunochemical test narrows current gaps in uptake for sex, age and deprivation in a bowel cancer screening programme. J Med Screen. 2013;20(2):80–5. doi:10.1177/0969141313497197. (Epub 2013/09/07).

    Article  PubMed  Google Scholar 

  22. Williams JA, Hunter R, Smith M, Coles ME, Hubert TW, Thomas DW. Evaluation of an immunological test for occult bleeding from colorectal neoplasia. Aust N Z J Surg. 1982;52(6):617–21. (Epub 1982/12/01).

    Article  CAS  PubMed  Google Scholar 

  23. St John DJ, Young GP, Alexeyeff MA, Deacon MC, Cuthbertson AM, Macrae FA, et al. Evaluation of new occult blood tests for detection of colorectal neoplasia. Gastroenterology. 1993;104(6):1661–8. (Epub 1993/06/01).

    CAS  PubMed  Google Scholar 

  24. Robinson MH, Marks CG, Farrands PA, Thomas WM, Hardcastle JD. Population screening for colorectal cancer: comparison between guaiac and immunological faecal occult blood tests. Br J Surg. 1994;81(3):448–51. (Epub 1994/03/01).

    Article  CAS  PubMed  Google Scholar 

  25. Rozen P, Knaani J, Papo N. Evaluation and comparison of an immunochemical and a guaiac faecal occult blood screening test for colorectal neoplasia. Eur J Cancer Prev. 1995;4(6):475–81. (Epub 1995/12/01).

    Article  CAS  PubMed  Google Scholar 

  26. Petrelli N, Michalek AM, Freedman A, Baroni M, Mink I, Rodriguez-Bigas M. Immunochemical versus guaiac occult blood stool tests: results of a community-based screening program. Surg Oncol. 1994;3(1):27–36. (Epub 1994/02/01).

    Article  CAS  PubMed  Google Scholar 

  27. Morikawa T, Kato J, Yamaji Y, Wada R, Mitsushima T, Shiratori Y. A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology. 2005;129(2):422–8. doi:10.1016/j.gastro.2005.05.056. (Epub 2005/08/09).

    Article  PubMed  Google Scholar 

  28. Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, et al. A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Ann Intern Med. 2007;146(4):244–55. (Epub 2007/02/21).

    Article  PubMed  Google Scholar 

  29. Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, et al. Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol. 2010;105(9):2017–25. doi:10.1038/ajg.2010.179. (Epub 2010/05/27).

    Article  PubMed  Google Scholar 

  30. Rabeneck L, Rumble RB, Thompson F, Mills M, Oleschuk C, Whibley A, et al. Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening. Cancer J Gastroenterol. 2012;26(3):131–47. (Epub 2012/03/13).

    Google Scholar 

  31. Young GP, Fraser CG, Halloran SP, Cole S. Guaiac based faecal occult blood testing for colorectal cancer screening: an obsolete strategy? Gut. 2012;61(7):959–60. doi:10.1136/gutjnl-2011-301810.

    Article  PubMed Central  PubMed  Google Scholar 

  32. Allison JE, Fraser CG, Halloran SP, Young GP. Comparing fecal immunochemical tests: improved standardization is needed. Gastroenterology. 2012;142(3):422–4. doi:10.1053/j.gastro.2012.01.015. (Epub 2012/01/28).

    Article  PubMed  Google Scholar 

  33. Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means means getting FIT. The past, present, and future of colorectal cancer screening using FIT. Gut Liver. 2014;8(2):117–30.

    Article  PubMed Central  PubMed  Google Scholar 

  34. Fraser CG, Allison JE, Halloran SP, Young GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst. 2012;104(11):810–4. doi:10.1093/jnci/djs190. (Epub 2012/04/05).

    Article  CAS  PubMed  Google Scholar 

  35. Fraser CG, Allison JE, Young GP, Halloran S. Newer fecal tests: opportunities for professionals in laboratory medicine. Clin Chem. 2012;58(6):963–5. doi:10.1373/clinchem.2012.185025. (Epub 27 March 2012).

    Article  CAS  PubMed  Google Scholar 

  36. Fraser CG, Allison JE, Young GP, Halloran SP. Quantitation of hemoglobin improves fecal immunochemical tests for noninvasive screening. Clin Gastroenterol Hepatol. 2013;11(7):839–40. doi:10.1016/j.cgh.2013.02.031. (Epub 2013 Apr 13).

    Article  CAS  PubMed  Google Scholar 

  37. Fraser CG, Allison JE, Young GP, Halloran SP, Seaman HE. A Standard for Faecal Immunochemical Tests for haemoglobin evaluation reporting (FITTER) (Letter). Ann Clin Biochem. 2014;51:301–2.

    Article  PubMed  Google Scholar 

  38. McDonald PJ, Anderson CM, Fraser CG. Acceptance quality checks for qualitative fecal immunochemical tests ensure screening program consistency. Int J Cancer. 2011;128(1):247–8. author reply 248–9. doi:10.1002/ijc.25316. (Epub 2010/03/17).

    Article  CAS  PubMed  Google Scholar 

  39. Digby J, Fraser CG, Carey FA, McDonald PJ, Strachan JA, Diament RH, et al. Faecal haemoglobin concentration is related to severity of colorectal neoplasia. J Clin Pathol. 2013;66(5):415–9. doi:10.1136/jclinpath-2013-201445. (Epub 2013/02/19).

    Article  CAS  PubMed  Google Scholar 

  40. Liao C-S, Lin Y-M, Chang H-C, Chen Y-H, Chong L-W, Chen C-H, et al. Application of quantitative estimates of fecal hemoglobin concentration for risk prediction of colorectal neoplasia. World J Gastroenterol. 2013;19(45):8366–72.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  41. Ciatto S, Martinelli F, Castiglione G, Mantellini P, Rubeca T, Grazzini G, et al. Association of FOBT-assessed faecal Hb content with colonic lesions detected in the Florence screening programme. Br J Cancer. 2007;96(2):218–21. doi:10.1038/sj.bjc.6603534. (Epub 2007/01/11).

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  42. Chen LS, Yen AM, Fraser CG, Chiu SY, Fann JC, Wang PE, et al. Impact of faecal haemoglobin concentration on colorectal cancer mortality and all-cause death. BMJ Open. 2013;3(11):e003740. doi:10.1136/bmjopen-2013-003740. (Epub 2013/11/10).

    Article  PubMed Central  PubMed  Google Scholar 

  43. Fraser CG. A future for faecal haemoglobin measurements in the medical laboratory. Ann Clin Biochem. 2012;49(6):518–26. doi:10.1258/acb.2012.012065. (Epub 2012/09/06).

    Article  CAS  PubMed  Google Scholar 

  44. Brenner H, Haug U, Hundt S. Inter-test agreement and quantitative cross-validation of immunochromatographical fecal occult blood tests. Int J Cancer. 2010;127(7):1643–9. doi:10.1002/ijc.25154. (Epub 2010/01/06).

    Article  CAS  PubMed  Google Scholar 

  45. Tao S, Seiler CM, Ronellenfitsch U, Brenner H. Comparative evaluation of nine faecal immunochemical tests for the detection of colorectal cancer. Acta Oncol. 2013;52(8):1667–75. doi:10.3109/0284186x.2013.789141. (Epub 2013/04/27).

    Article  PubMed  Google Scholar 

  46. Tao S, Brenner H. Well adjusted qualitative immunochemical faecal occult blood tests could be a promising alternative for inexpensive, high-quality colorectal cancer screening. Eur J Cancer Prev. 2013;22(4):305–10. doi:10.1097/CEJ.0b013e32835b6991.

    Article  CAS  PubMed  Google Scholar 

  47. Grazzini G, Ventura L, Zappa M, Ciatto S, Confortini M, Rapi S, et al. Influence of seasonal variations in ambient temperatures on performance of immunochemical faecal occult blood test for colorectal cancer screening: observational study from the Florence district. Gut. 2010;59(11):1511–5. doi:10.1136/gut.2009.200873. (Epub 2010/07/07).

    Article  PubMed  Google Scholar 

  48. Carroll MRR, Piggott C, Pearson S, Seaman HE, Halloran SP. Evaluation of quantitative faecal immunochemical tests for haemoglobin. Guildford: Guildford Medical Device Evaluation Centre (GMEC). 2013. http://worldendo.org/assets/downloads/pdf/activities/fit_reports/gmec_fit_evaluation_report.pdf. Accessed 17 Sept 2014.

  49. Fraser CG. Fecal occult blood tests. Life savers or outdated colorectal screening tools? Clin Lab News. 2011;37:8–10.

    Google Scholar 

  50. Niv Y. Fecal occult blood test–the importance of proper evaluation. J Clin Gastroenterol. 1990;12(4):393–5.

    Article  CAS  PubMed  Google Scholar 

  51. Fleisher M, Winawer SJ, Zauber AG, Smith C, Schwartz MK. Accuracy of fecal occult blood test interpretation. National Polyp Study Work Group. Ann Intern Med. 1991;114(10):875–6.

    Article  CAS  PubMed  Google Scholar 

  52. Selinger RR, Norman S, Dominitz JA. Failure of health care professionals to interpret fecal occult blood tests accurately. Am J Med. 2003;114(1):64–7. doi:S0002934302013505 [pii].

    Article  PubMed  Google Scholar 

  53. Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H, Chejfec G. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. Veterans Affairs Cooperative Study Group 380. N Engl J Med. 2000;343(3):162–8. doi:10.1056/nejm200007203430301. (Epub 2000/07/20).

    Article  CAS  PubMed  Google Scholar 

  54. Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings. N Engl J Med. 2000;343(3):169–74. doi:10.1056/nejm200007203430302. (Epub 2000/07/20).

    Article  CAS  PubMed  Google Scholar 

  55. Centers for Disease Control and Prevention. Vital signs: colorectal cancer screening test use—United States, 2012. Centers for Disease Control and Prevention. 2013 (updated 8 Nov 2013; cited 62). http://www.cdc.gov/mmwr/pdf/wk/mm6244.pdf.

  56. National Colorectal Cancer Roundtable. Tools & Resources—The New FOBT Clinician’s Reference Resource. Updated 20 Dec 2013. http://nccrt.org/about/provider-education/fobt-clinicians-reference-resources.

  57. Kahi CJ, Anderson JC, Rex DK. Screening and surveillance for colorectal cancer: state of the art. Gastrointest Endosc. 2013;77(3):335–50. doi:10.1016/j.gie.2013.01.002. (Epub 2013/02/16).

    Article  PubMed  Google Scholar 

  58. Qaseem A, Denberg TD, Hopkins RH, Humphrey LL, Levine J, Sweet DE, et al. Screening for colorectal cancer: a guidance statement from the American college of physicians. Ann Intern Med. 2012;156(5):378–86. doi:10.1059/0003-4819-156-5-201203060-00010.

    Article  PubMed  Google Scholar 

  59. Sugerman D. Options for colorectal cancer screening. JAMA. 2013;310(6):658. doi:10.1001/jama.2013.57593.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgement

The authors thank Dr. Helen Seaman for her help in preparing this manuscript for publication.

Author information

Authors and Affiliations

  1. Department of Internal Medicine/Gastroenterology, University of California San Francisco, SFGH Campus, 1001 Potrero Avenue, 94110, San Francisco, CA, USA

    James E. Allison

  2. Centre for Research into Cancer Prevention and Screening, University of Dundee, Dundee, Scotland

    Callum G. Fraser

  3. Clinical Biochemistry, Royal Surrey County Hospital, University of Surrey, Guildford, Surrey, UK

    Stephen P. Halloran

  4. Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, SA, Australia

    Graeme P. Young

Authors
  1. James E. Allison
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Callum G. Fraser
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Stephen P. Halloran
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Graeme P. Young
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to James E. Allison .

Editor information

Editors and Affiliations

  1. Department of Gastroenterology, Minneapolis VA Medical Center, Minneapolis, Minnesota, USA

    Aasma Shaukat

  2. Department of Medicine, Yale University, New Haven, Connecticut, USA

    John I. Allen

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer Science+Business Media New York

About this chapter

Cite this chapter

Allison, J., Fraser, C., Halloran, S., Young, G. (2015). Quality Indicators and Benchmarks for Guideline-Recommended Fecal Occult Blood Tests. In: Shaukat, A., Allen, J. (eds) Colorectal Cancer Screening. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2333-5_4

Download citation

  • DOI: https://doi.org/10.1007/978-1-4939-2333-5_4

  • Published:

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4939-2332-8

  • Online ISBN: 978-1-4939-2333-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation