Result card

  • TEC18: Are the reference values or cut-off points clearly established?
Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening
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Are the reference values or cut-off points clearly established?

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cristian Vladescu

Internal reviewers: Antonio Migliore, Pernilla Östlund, Frida Mowafi, Daniela d’Angela, Jesus Gonzalez

Results {5-8,20}

Cut-off limits are important in CRC screening due the fact that, by increasing the positive cut-off limit, the test sensitivity and positivity rate decreases and specificity and positive predictive values for CRC detection increase.

European guidelines {6} state that “the choice of a cut-off concentration to be used in an immunochemical test to discriminate between a positive and negative result will depend on the test device chosen, the number of samples used and the algorithm adopted to integrate the individual test results. Whilst an increasing number of studies are reporting the experience of different algorithms, local conditions, including the effect on sample stability of transport conditions, preclude a simple prescribed algorithm at this time. Adoption of a test device and the selection of a cut-off concentration should follow a local pilot study to ensure that the chosen test, test algorithm and transport arrangements work together to provide a positivity rate that is clinically, logistically and financially acceptable (VI - A)”.

Two out of three iFOBT are quantitative tests and have adjustable or user defined cut-off values (OC-Sensor and The FOB Gold); Hem-SP/MagStream HT is qualitative, and has a non-adjustable cut-off value:

  • OC-Sensor is CE marked for a user defined cut-off (default setting 100 ng/mL), with 20 ng/mL in buffer as limit of detection.;
  • Hem-SP/MagStream HT is qualitative, and has a non-adjustable cut-off at a Hb concentration equal to or greater than 20 ng/ml;
  • The FOB Gold is CE marked for a user defined cut-off, with limit of detection of 14 ng/mL buffer, and measuring range of 15-1000 ng/ml.

 

Van Rossum at al. {20}, using OC-Sensor collection and OC-Micro analyser  concluded that cut-off of 75 ng/ml brought optimal results and may be recommended for population screening in Netherlands. They concluded also in settings where colonoscopy capacity is insufficient, a cut-off up to 200ng/ml would result in minimal false negative results for cancer although more for advance adenoma.

 

Critical
Completely
Huic M et al. Result Card TEC18 In: Huic M et al. Description and technical characteristics of technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 28 June 2022]. Available from: http://corehta.info/ViewCover.aspx?id=206

References

1.         Young GP, St John DJ, Winawer SJ, Rozen P. 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. The American journal of gastroenterology. 2002;97(10):2499-507. eng.

2.         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. Canadian Journal of Gastroenterology. 2012;26(3):131-47. eng.

3.         Health Information and Quality Authority. Health technology assessment (HTA) of a population-based colorectal cancer screening programme in Ireland. Dublin: Health Information and Quality Authority, 2009.

4.         Rabeneck L RR, Thompson F, Mills M, Oleschuk C, Whibley AH, et al. Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening. Toronto, ON: Cancer Care Ontario, 2011 Nov 8  Contract No.: Program in Evidence-based Care Evidence-based Series No.: 15-8.

5.         NHS Centre for Evidence-based Purchasing. Evaluation report: Immunohistocemical faecal occult blood tests. NHS Purchasing and Supply Agency, 2009 CEP09042.

6.         Segnan N, Patnick J, von Karsa L, editors. European guidelines for quality assurance in colorectal cancer screening and diagnosis - First Edition. 1st ed. Luxembourg: Publications Office of the European Union; 2010.

7.         Whyte S, Chilcott J, Cooper K, Essat M, Stevens J, Wong R, et al. Re-appraisal of the options for colorectal cancer screening. Report for the NHS Bowel Cancer Screening Programme. Sheffield: University of Sheffield, School of Health and related Research, 2011.

8.         Guittet L, Guillaume E, Levillain R, Beley P, Tichet J, Lantieri O, et al. Analytical comparison of three quantitative immunochemical fecal occult blood tests for colorectal cancer screening. Cancer Epidemiol Biomarkers Prev. 2011 2011 Jul;20(7):1492-501. eng.

9.         von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. eng.

10.       van Rossum LGM, van Rijn AF, van Oijen MGH, Fockens P, Laheij RJF, Verbeek ALM, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. International Journal of Cancer. 2009;125(4):746-50.

11.       Young GP. Fecal immunochemical tests (FIT) vs. office-based guaiac fecal occult blood test (FOBT). Pract Gastroenterol. 2004 2004;28(6):46-56.

12.       Lin J, Webber E, Beil T, Goddard K, EP W. Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults. Rockville, MD: Agency for Healthcare Research and Quality, 2012  Contract No.: AHRQ Publication 12-EHC022-EF.

13.       Exact Sciences Corp. Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer. [Internet]. 2013, April 18 [cited 2013 Aug 9]. Available from: http://investor.exactsciences.com/releasedetail.cfm?ReleaseID=757341.

14.       ClinicalTrials.gov. Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C) [Internet]. U.S. National Institutes of Health; 2013, Jun 18 [cited 2013 Aug 9]. Available from: http://prsinfo.clinicaltrial.gov/ct2/show/record/NCT01397747?id=NCT01397747&rank=1).

15.       Council of the European Union. Recommendation of 2 December 2003 on cancer screening. 2003/878/EC. Off J Eur Union. 2003:34–8.

16.       Medical Advisory Secretariat. Screening Methods for Early Detection of Colorectal Cancers and Polyps. Summary of Evidence-Based Analyses. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care, 2009  Contract No.: 6.

17.       Epigenomics AG. Epigenomics AG submits the fourth module and completes its PMA submission to the FDA for Epi proColon®. [Internet]. Epigenomics AG,; 2013, Jan 7 [cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

18.       ClinicalTrials.gov. Head to Head Study Epi proColon and FIT. [Internet]. U.S. National Institutes of Health; 2013 [updated 2013, Feb 6; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

19.       Epigenomics AG. Results of Comparative Study between Epigenomics Epi proColon® and FIT to be Presented at Digestive Disease Week. [Internet]. Epigenomics AG,; 2013, Mar 15 [updated 2011; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

20.       van Rossum LGM, van Rijn AF, Laheij RJF, van Oijen MGH, Fockens P, Jansen JBMJ, et al. Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme. British journal of cancer. 2009;101(8):1274-81.