The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer

Abstract

Purpose

Fecal immunochemical tests (FITs) have been developed to address analytical problems inherent in the older guaiac-based fecal occult blood tests (g-FOBTs). Our aim was to compare the performance characteristics of one g-FOBT (Hemoccult II) and two FITs (the Hemoccult ICT and MagStream HemSp) relative to colonoscopy for the detection of colorectal cancer and significant precursor lesions. We also examined whether a 1-day collection strategy would negatively impact test diagnostic performance.

Methods

We used a prospective observational cohort design in a Canadian population eligible for screening. All participants received colonoscopy after performing the occult blood tests.

Results

One thousand seventy-five individuals were enrolled (mean age 56.3 years, 53.8 % females). Using colonoscopy as the gold standard, the sensitivity for screen-relevant neoplasm was determined for Hemoccult II (7.2, 95 % CI: 1.1–13.4), Hemoccult ICT (23.2 %: 13.2–33.1), and MagStream HemSp using 67 μg/gram stool as the cut-off (23.2 %: 13.2–33.1). The Magstream HemSp, using a cut-off threshold of 30 μg/gram stool, had the lowest specificity at 87.6 % (85.4–89.6), while the Hemoccult II had the highest at 98.8 % (98.1–99.5). Single-day stool testing reduced the false-positive rates of all tests without significantly reducing the sensitivity.

Conclusion

We found that FITs have a significantly increased sensitivity but reduced specificity for screen-relevant neoplasm compared to g-FOBT using colonoscopy as the gold standard. Optimal threshold levels for hemoglobin detection depend on the desired trade off between sensitivity and false-positive rate. Single-day testing with an FIT may be an option to enhance population compliance with screening.

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Fig. 1

Abbreviations

FOBT:

Fecal occult blood tests

FIT:

Fecal immunochemical tests

g-FOBTs:

Guaiac-based occult blood tests

References

  1. 1.

    Hardcastle JD, Thomas WM, Chamberlain J, Pye G, Sheffield J, James PD, Balfour TW, Amar SS, Armitage NC, Moss SM (1989) Randomised, controlled trial of faecal occult blood screening for colorectal cancer. Results for first 107,349 subjects. Lancet 1:1160–1164

    PubMed  Article  CAS  Google Scholar 

  2. 2.

    Faivre J, Dancourt V, Lejeune C, Tazi MA, Lamour J, Gerard D, Dassonville F, Bonithon-Kopp C (2004) Reduction in colorectal cancer mortality by fecal occult blood screening in a French controlled study. Gastroenterology 126:1674–1680

    PubMed  Article  Google Scholar 

  3. 3.

    Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F (1993) Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med 328:1365–1371

    PubMed  Article  CAS  Google Scholar 

  4. 4.

    Mandel JS, Church TR, Ederer F, Bond JH (1999) Colorectal cancer mortality: effectiveness of biennial screening for fecal occult blood. J Natl Canc Inst 91:434–437

    Article  CAS  Google Scholar 

  5. 5.

    Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O (1996) Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 348:1467–1471

    PubMed  Article  CAS  Google Scholar 

  6. 6.

    Young GP, St John DJ, Winawer SJ, Rozen P (2002) Choice of fecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organization) and OMED (World Organization for Digestive Endoscopy) report. Am J Gastroenterol 97:2499–2507

    PubMed  Google Scholar 

  7. 7.

    Allison JE, Tekawa IS, Ransom LJ, Adrain AL (1996) A comparison of fecal occult-blood tests for colorectal-cancer screening. N Engl J Med 334:155–159

    PubMed  Article  CAS  Google Scholar 

  8. 8.

    Rozen P, Knaani J, Samuel Z (1997) Performance characteristics and comparison of two immunochemical and two guaiac fecal occult blood screening tests for colorectal neoplasia. Dig Dis Sci 42:2064–2071

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Zappa M, Castiglione G, Paci E, Grazzini G, Rubeca T, Turco P, Crocetti E, Ciatto S (2001) Measuring interval cancers in population-based screening using different assays of fecal occult blood testing: the District of Florence experience. Int J Cancer 92:151–154

    PubMed  Article  CAS  Google Scholar 

  10. 10.

    Hol L, Wilschut JA, van Ballegooijen M, van Vuuren AJ, van der Valk H, Reijerink JC, van der Togt AC, Kuipers EJ, Habbema JD, van Leerdam ME (2009) Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer 100:1103–1110

    PubMed  Article  CAS  Google Scholar 

  11. 11.

    Federici A, Giorgi Rossi P, Borgia P, Bartolozzi F, Farchi S, Gausticchi G (2005) The immunochemical faecal occult blood test leads to higher compliance than the guaiac for colorectal cancer screening programmes: a cluster randomized controlled trial. J Med Screen 12:83–88

    PubMed  Article  Google Scholar 

  12. 12.

    Hughes K, Leggett B, Del Mar C, Croese J, Fairley S, Masson J, Aitken J, Clavarino A, Janda M, Stanton WR, Tong S, Newman B (2005) Guaiac versus immunochemical tests: faecal occult blood test screening for colorectal cancer in a rural community. Aust N Z J Public Health 29:358–364

    PubMed  Article  Google Scholar 

  13. 13.

    Cole SR, Young GP, Esterman A, Cadd B, Morcom J (2003) A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. J Med Screen 10:117–122

    PubMed  Article  CAS  Google Scholar 

  14. 14.

    Morikawa T, Kato J, Yamaji Y, Wada R, Mitsushima T, Shiratori Y (2005) A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology 129:422–428

    PubMed  Google Scholar 

  15. 15.

    Beckman Coulter I (2003) Hemoccult II product instructions. In: Editor (ed)^(eds) Book Hemoccult II product instructions. Beckman Coulter, Inc., City, pp

  16. 16.

    Beckman Coulter I Hemoccult ICT. In: Editor (ed)^(eds) Book hemoccult ICT. Beckman Coulter, Inc., City, pp

  17. 17.

    Alonzo TA, Pepe MS, Moskowitz CS (2002) Sample size calculations for comparative studies of medical tests for detecting presence of disease. Stat Med 21:835–852

    PubMed  Article  Google Scholar 

  18. 18.

    Hundt S, Haug U, Brenner H (2009) Comparative evaluation of immunochemical fecal occult blood tests for colorectal adenoma detection. Ann Intern Med 150:162–169

    PubMed  Google Scholar 

  19. 19.

    Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Leshno M, Niv Y (2007) A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Ann Intern Med 146:244–255

    PubMed  Google Scholar 

  20. 20.

    Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, Han DS (2010) Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol 105:2017–2025

    PubMed  Article  Google Scholar 

  21. 21.

    Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM (2009) American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol 104:739–750

    PubMed  Article  Google Scholar 

  22. 22.

    Rabeneck L, Rumble RB, Thompson F, Mills M, Oleschuk C, Whibley A, Messersmith H, Lewis N (2012) Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening. Can J Gastroenterol 26:131–147

    PubMed  Google Scholar 

  23. 23.

    Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ (2008) 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 134:1570–1595

    PubMed  Article  CAS  Google Scholar 

  24. 24.

    Rozen P, Comaneshter D, Levi Z, Hazazi R, Vilkin A, Maoz E, Birkenfeld S, Niv Y (2010) Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use. Cancer 116:2115–2125

    PubMed  CAS  Google Scholar 

  25. 25.

    Taylor KL, Shelby R, Gelmann E, McGuire C (2004) Quality of life and trial adherence among participants in the prostate, lung, colorectal, and ovarian cancer screening trial. J Natl Canc Inst 96:1083–1094

    Article  Google Scholar 

  26. 26.

    Castiglione G, Zappa M, Grazzini G, Sani C, Mazzotta A, Mantellini P, Ciatto S (1997) Cost analysis in a population-based screening programme for colorectal cancer: comparison of immunochemical and guaiac faecal occult blood testing. J Med Screen 4:142–146

    PubMed  CAS  Google Scholar 

  27. 27.

    Fenton JJ, Elmore JG, Buist DS, Reid RJ, Tancredi DJ, Baldwin LM (2010) Longitudinal adherence with fecal occult blood test screening in community practice. Ann Fam Med 8:397–401

    PubMed  Article  Google Scholar 

  28. 28.

    van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, Verbeek AL, Jansen JB, Dekker E (2008) Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology 135:82–90

    PubMed  Article  Google Scholar 

  29. 29.

    Allison JE, Sakoda LC, Levin TR, Tucker JP, Tekawa IS, Cuff T, Pauly MP, Shlager L, Palitz AM, Zhao WK, Schwartz JS, Ransohoff DF, Selby JV (2007) Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteristics. J Natl Canc Inst 99:1462–1470

    Article  Google Scholar 

  30. 30.

    Haug U, Hundt S, Brenner H (2010) Quantitative immunochemical fecal occult blood testing for colorectal adenoma detection: evaluation in the target population of screening and comparison with qualitative tests. Am J Gastroenterol 105:682–690

    PubMed  Article  Google Scholar 

  31. 31.

    Fraser CG, Allison JE, Halloran SP, Young GP (2012) A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst E-pub ahead of print

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Acknowledgments

The study was funded by the Capital Health Authority, Edmonton, Alberta, Canada. Beckman Coulter Inc, USA provided Hemoccult ICT collection cards and test devices. Fujirebio Inc, Japan provided the Magstream HT. Reagents and support were provided by Fujirebio Diagnostics Inc, USA. Grammatical revisions and manuscript formatting was performed by Joanne Simala-Grant and Kathleen Ismond (funding from Dr DC Sadowski, Academic Trust Account).

Conflict of interest

No conflicts relevant to the manuscript for all authors.

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Correspondence to Daniel C. Sadowski.

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Wong, C.K.W., Fedorak, R.N., Prosser, C.I. et al. The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. Int J Colorectal Dis 27, 1657–1664 (2012). https://doi.org/10.1007/s00384-012-1518-3

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Keywords

  • Fecal occult blood tests
  • Colon cancer screening
  • Tumor markers
  • Disease prevention
  • Sensitivity
  • Specificity