Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

12 Issues per year

IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

See all formats and pricing
More options …
Volume 54, Issue 4


Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms

Ian M. Godber / Louise M. Todd / Callum G. Fraser
  • Centre for Research into Cancer Prevention and Screening, Ninewells Hospital and Medical School, Dundee, Scotland, UK
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Linda R. MacDonald / Hakim Ben Younes
Published Online: 2015-10-10 | DOI: https://doi.org/10.1515/cclm-2015-0617


Background: This study aimed to determine whether patients with lower abdominal symptoms can be investigated quickly using results of faecal haemoglobin concentration (f-Hb) measurements, and whether this test could form part of a diagnostic pathway for significant colorectal disease.

Methods: Nine hundred and nine consecutive patients referred from primary care for colonoscopy were invited: 507 submitted samples for f-Hb measurement with a quantitative faecal immunochemical test for haemoglobin (FIT) (HM-JACKarc, Kyowa-Medex, Japan) and a diagnostic colonoscopy was completed in 484 patients.

Results: Colorectal cancer (CRC), higher risk adenoma (HRA), inflammatory bowel disease (IBD) and/or colitis was found in 45 patients (9.3%); these had significantly higher (p<0.0001) f-Hb than the group of 243 with normal colonoscopy plus the 196 patients with less significant clinical findings. The 11 (2.2%) patients with CRC all had f-Hb >190 μg Hb/g faeces. Using a f-Hb cut-off of 10 μg Hb/g faeces, for the group with CRC or HRA or IBD or colitis, sensitivity was 68.9%, specificity 80.2%, positive predictive value (PPV) 26.3% and negative predictive value (NPV) 96.2%. Sensitivity and NPV were 100% for CRC suggesting f-Hb is a good rule-in test for CRC. Of the 243 patients with normal colonoscopy, 81.2% had f-Hb<10 μg Hb/g faeces.

Conclusions: The high NPV for significant colorectal diseases suggests that f-Hb could be used as a rule-out test in this context. Potential exists for using f-Hb measurements to investigate symptomatic patients and guide the use of colonoscopy resources: detailed algorithms for the introduction of f-Hb measurements requires further exploration.

Keywords: colorectal cancer; colorectal disease; diagnostic accuracy; faecal haemoglobin; faecal immunochemical test; negative predictive value; positive predictive value; sensitivity; specificity


  • 1.

    Bowelcanceruk. Diagnosing bowel cancer early: right test, right time, 2014 Available at: http://www.bowelcanceruk.org.uk/campaigns-policy/latest-campaigns/right-test,-right-time/read-our-report/. Accessed: 28 June 2015.

  • 2.

    SIGN. Diagnosis and Management of Colorectal Cancer. SIGN: Edinburgh, 2011 Available at: http://www.sign.ac.uk/guidelines/fulltext/126/. Accessed: 28 June 2015

  • 3.

    Goddard FA, James MW, McIntyre AS, Scott BB on behalf of the BSG. Guidelines for the management of iron deficiency anaemia. Gut 2011;60:1309–16.CrossrefGoogle Scholar

  • 4.

    Carroll MR, Seaman HE, Halloran SP. Tests and investigations for colorectal cancer screening. Clin Biochem 2014;47:921–39.CrossrefWeb of ScienceGoogle Scholar

  • 5.

    National Institute for Health and Care Excellence. NICE NG12. Recognition and referal. NICE: London, 2015 Available at: http://www.nice.org.uk/guidance/ng12. Accessed:28 June 2015.

  • 6.

    Oono Y, Iriguchi Y, Doi Y, Tomino Y, Kishi D, Oda J, et al. A retrospective study of immunochemical fecal blood testing for colorectal cancer detection. Clin Chim Acta 2010;411:802–5.Web of ScienceGoogle Scholar

  • 7.

    Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means getting FIT: the past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT). Gut Liver 2014;8:117–30.CrossrefGoogle Scholar

  • 8.

    McDonald PJ, Digby J, Innes C, Strachan JA, Carey FA, Steele RJ, et al. Low faecal haemoglobin concentration potentially rules out significant colorectal disease. Colorectal Dis 2013;15:e151–9.Web of ScienceCrossrefGoogle Scholar

  • 9.

    Cubiella J, Salve M, Díaz-Ondina M, Alves MT, Iglesias F, Sánchez E, et al. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis 2014;16:O273–82.Web of ScienceCrossrefGoogle Scholar

  • 10.

    Kaul A, Shah A, Magill FH, Hawkins SA, Skaife P. Immunological faecal occult blood testing: a discriminatory test to identify colorectal cancer in symptomatic patients. Int J Surg 2013;11:329–31.Web of ScienceCrossrefGoogle Scholar

  • 11.

    Ochodo EA, Bossuyt PM. Reporting the accuracy of diagnostic tests: the STARD initiative 10 years on. Clin Chem 2013;59:917–9.Web of ScienceCrossrefGoogle Scholar

  • 12.

    GMEC Evaluation Team; Evaluation of quantitative faecal immunochemical tests for haemoglobin, 2013. Available at http://www.worldendo.org/assets/downloads/pdf/activities/fit_reports/gmec_fit_evaluation_report.pdf. Accessed: 31 August 2015.

  • 13.

    Fujimura K, Kurita Y, Nishimura E, Yamaguchi J, Mori S, Satho H. Comparison study of automated immunochemical fecal occult blood test analyser performance. J Clin Lab Instrum Reagents 2013;36:679–85.Google Scholar

  • 14.

    Atkin WS, Saunders BP. Surveillance guidelines after removal of colorectal adenomatous polyps. Gut 2002;51:Suppl v:v6–9.CrossrefGoogle Scholar

  • 15.

    Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, et al. Advances in fecal occult blood tests: the FIT revolution. Dig Dis Sci 2015;60:609–22.CrossrefWeb of ScienceGoogle Scholar

  • 16.

    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;66:415–9.CrossrefWeb of ScienceGoogle Scholar

  • 17.

    Liao CS, Lin YM, Chang HC, Chen YH, Chong LW, Chen CH, et al. Application of quantitative estimates of fecal hemoglobin concentration for risk prediction of colorectal neoplasia. World J Gastroenterol 2013;19:8366–72.Web of ScienceCrossrefGoogle Scholar

  • 18.

    Garcia M, Milà N, Binefa G, Benito L, Gonzalo N, Moreno V. Fecal hemoglobin concentration as a measure of risk to tailor colorectal cancer screening: are we there yet? Eur J Cancer Prev 2015;24:321–7.CrossrefGoogle Scholar

  • 19.

    Auge JM, Pellise M, Escudero JM, Hernandez C, Andreu M, Grau J, et al. Risk stratification for advanced colorectal neoplasia according to fecal hemoglobin concentration in a colorectal cancer screening program. Gastroenterology 2014;147:628–36.Web of ScienceGoogle Scholar

  • 20.

    Fraser CG, Rubeca T, Rapi S, Chen LS, Chen HH. Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening. Clin Chem Lab Med 2014;52:1211–6.Web of ScienceCrossrefGoogle Scholar

  • 21.

    Symonds EL, Osborne J, Cole SR, Bampton P, Fraser R, Young GP. Gender differences in faecal haemoglobin concentration. J Med Screen 2015; Jul 20 [Epub ahead of print]Web of ScienceGoogle Scholar

  • 22.

    Mowat C, Digby J, Strachan JA, Wilson R, Carey FA, Fraser CG, et al. Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms. Gut 2015; Aug 20 [Epub ahead of print]Google Scholar

  • 23.

    Auge JM, Fraser CG, Rodriguez C, Roset A, Lopez-Ceron M, Grau J, et al. Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients. Clin Chem Lab Med 2016;54:125–32.Web of ScienceCrossrefGoogle Scholar

  • 24.

    van Dam L, Kuipers EJ, van Leerdam ME. Performance improvements of stool-based screening tests. Best Pract Res Clin Gastroenterol 2010;24:479–92.Web of ScienceCrossrefGoogle Scholar

  • 25.

    Kok L, Elias SG, Witteman BJ, Goedhard JG, Muris JW, Moons KG, et al. Diagnostic accuracy of point-of-care fecal calprotectin and immunochemical occult blood tests for diagnosis of organic bowel disease in primary care: the Cost-Effectiveness of a Decision rule for Abdominal complaints in primary caRe (CEDAR) study. Clin Chem 2012;58:89–98.CrossrefWeb of ScienceGoogle Scholar

  • 26.

    Rodríguez-Alonso L, Rodríguez-Moranta F, Ruiz-Cerulla A, Lobatón T, Arajol C, Binefa G, et al. An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test. Dig Liver Dis 2015;47:797–804.CrossrefWeb of ScienceGoogle Scholar

  • 27.

    Wu D, Luo HQ, Zhou WX, Qian JM, Li JN. The performance of three-sample qualitative immunochemical fecal test to detect colorectal adenoma and cancer in gastrointestinal outpatients: an observational study. PLoS One 2014;9:e106648.Web of ScienceCrossrefGoogle Scholar

  • 28.

    Jellema P, van der Windt DA, Bruinvels DJ, Mallen CD, van Weyenberg SJ, Mulder CJ, et al. Value of symptoms and additional diagnostic tests for colorectal cancer in primary care: systematic review and meta-analysis. Br Med J 2010;340:c1269.Google Scholar

About the article

Corresponding author: Dr. Ian M. Godber, Consultant Clinical Scientist, NHS Lanarkshire, Department of Biochemistry, Monklands Hospital, Airdrie, Lanarkshire, ML6 0JS, Scotland, UK, E-mail:

Received: 2015-06-30

Accepted: 2015-09-10

Published Online: 2015-10-10

Published in Print: 2016-04-01

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 54, Issue 4, Pages 595–602, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2015-0617.

Export Citation

©2016 by De Gruyter.Get Permission

Citing Articles

Here you can find all Crossref-listed publications in which this article is cited. If you would like to receive automatic email messages as soon as this article is cited in other publications, simply activate the “Citation Alert” on the top of this page.

Christian von Wagner, Sandro Stoffel, Madeleine Freeman, Helga Laszlo, Brian D Nicholson, Jessican Sheringham, Dorothy Szinay, and Yasemin Hirst
British Journal of General Practice, 2018, Page bjgp18X699413
Jakob Søgaard Juul, Nete Hornung, Berit Andersen, Søren Laurberg, Frede Olesen, and Peter Vedsted
British Journal of Cancer, 2018
Aaron J Quyn, Robert JC Steele, Jayne Digby, Judith A Strachan, Craig Mowat, Paula J McDonald, Francis A Carey, Ian M Godber, Hakim B Younes, and Callum G Fraser
Annals of Clinical Biochemistry: International Journal of Laboratory Medicine, 2018, Volume 55, Number 1, Page 69
Anton R. Lord, Lisa A. Simms, Allison Brown, Katherine Hanigan, Krupa Krishnaprasad, Belinda Schouten, Anthony R. Croft, Mark N. Appleyard, and Graham L. Radford-Smith
BMC Cancer, 2018, Volume 18, Number 1
Marie Westwood, Shona Lang, Nigel Armstrong, Sietze van Turenhout, Joaquín Cubiella, Lisa Stirk, Isaac Corro Ramos, Marianne Luyendijk, Remziye Zaim, Jos Kleijnen, and Callum G. Fraser
BMC Medicine, 2017, Volume 15, Number 1
Marie Westwood, Isaac Corro Ramos, Shona Lang, Marianne Luyendijk, Remziye Zaim, Lisa Stirk, Maiwenn Al, Nigel Armstrong, and Jos Kleijnen
Health Technology Assessment, 2017, Volume 21, Number 33, Page 1
Joaquín Cubiella, Jayne Digby, Lorena Rodríguez-Alonso, Pablo Vega, María Salve, Marta Díaz-Ondina, Judith A. Strachan, Craig Mowat, Paula J. McDonald, Francis A. Carey, Ian M. Godber, Hakim Ben Younes, Francisco Rodriguez-Moranta, Enrique Quintero, Victoria Álvarez-Sánchez, Fernando Fernández-Bañares, Jaume Boadas, Rafel Campo, Luis Bujanda, Ana Garayoa, Ángel Ferrandez, Virginia Piñol, Daniel Rodríguez-Alcalde, Jordi Guardiola, Robert J.C. Steele, and Callum G. Fraser
International Journal of Cancer, 2017, Volume 140, Number 10, Page 2201
Sjoerd G. Elias, Liselotte Kok, Niek J. de Wit, Ben J. M Witteman, Jelle G. Goedhard, Mariëlle J. L. Romberg-Camps, Jean W. M. Muris, and Karel G. M. Moons
BMC Medicine, 2016, Volume 14, Number 1
Joaquín Cubiella, Pablo Vega, María Salve, Marta Díaz-Ondina, Maria Teresa Alves, Enrique Quintero, Victoria Álvarez-Sánchez, Fernando Fernández-Bañares, Jaume Boadas, Rafel Campo, Luis Bujanda, Joan Clofent, Ángel Ferrandez, Leyanira Torrealba, Virginia Piñol, Daniel Rodríguez-Alcalde, Vicent Hernández, and Javier Fernández-Seara
BMC Medicine, 2016, Volume 14, Number 1

Comments (0)

Please log in or register to comment.
Log in