Fecal Immunochemical Testing in Patients With Low-Risk Symptoms of Colorectal Cancer: A Diagnostic Accuracy Study

Authors: Alex J. Ball MRCP1, Imran Aziz MRCP1,2, Sophie Parker BSc1, Ravishankar B. Sargur FRCPath3, Jonathan Aldis MSc3, and Matthew Kurien FRCP1,2
View More View Less
  • 1 Department of Gastroenterology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield;
  • | 2 Academic Unit of Gastroenterology, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield Medical School, Sheffield, South Yorkshire; and
  • | 3 Department of Allergy and Immunology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.

Background: The fecal immunochemical test (FIT) is recommended for triaging primary care patients in England with low-risk symptoms of colorectal cancer (CRC). The evidence underpinning recommendations by the National Institute for Health and Care Excellence had limitations, with a paucity of primary care evidence. This study examines the diagnostic accuracy of FIT in a defined low-risk symptom primary care population. Patients and Methods: Consecutive symptomatic adult patients referred for a FIT between October and December 2019 were included. Patients were derived from 225 primary care practices in England. Serious colorectal diseases (CRC, high-risk polyps, and inflammatory bowel disease [IBD]) were identified through patient follow-up over 18 months, using both primary and secondary healthcare records. Performance characteristics of FIT are reported according to differing thresholds, including the currently recommended threshold of ≥10 μg hemoglobin per gram of feces (μg/g). Results: A total of 3,506 patients were included in the final analysis. Of these, 708 had a positive FIT result (≥10 μg/g). The prevalence of CRC was 1.3%. FIT positivity declined from 20.2% to 5.8% and 4.5% at cutoffs of 10, 80, and 120 μg/g, respectively. The sensitivity of FIT at ≥10 μg/g to detect CRC was 91.1% (95% CI, 77.9%–97.1%); its specificity was 80.7% (95% CI, 79.3%–82.0%); the positive predictive value (PPV) was 5.8% (95% CI, 4.2%–7.8%); and the negative predictive value (NPV) was 99.9% (95% CI, 99.6%–99.95%). The area under the receiver operating characteristic curve was 0.93 (0.91–0.96). PPV and specificity increased, whereas sensitivity and NPV decreased when serious colorectal diseases (CRC, high-risk polyps, and IBD) were combined. Age, sex, socioeconomic deprivation, and anemia did not significantly influence FIT sensitivity on subgroup analysis. Conclusions: Utilization of FIT at a threshold ≥10 μg/g can safely triage patients with low-risk symptoms in primary care, with negative results effectively ruling out CRC.

Submitted February 24, 2022; final revision received May 23, 2022; accepted for publication May 23, 2022.

Author contributions: Study concept and design: Ball, Aziz, Sargur, Kurien. Data acquisition: All authors. Data analysis and interpretation: Parker, Kurien. Manuscript preparation: Ball, Aziz, Kurien. Critical revision: All authors.

Disclosures: The authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: This research was supported by funding from the South Yorkshire, Bassetlaw & North Derbyshire Cancer Alliance. The funding body were not involved in the conduct of the research, manuscript preparation, data analysis, or influenced the decision to submit to JNCCN. The authors have no other financial disclosures to declare.

Correspondence: Matthew Kurien, MRCP, Academic Unit of Gastroenterology, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Medical School, Beech Hill Road, Sheffield, Sheffield S10 2RX, United Kingdom. Email: m.kurien@sheffield.ac.uk

Supplementary Materials

    • Supplemental Materials (PDF 432 KB)
  • 1.

    Holtedahl K, Vedsted P, Borgquist L, et al. Abdominal symptoms in general practice: frequency, cancer suspicions raised, and actions taken by GPs in six European countries. Cohort study with prospective registration of cancer. Heliyon 2017;3:e00328.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2.

    Hamilton W, Sharp D. Diagnosis of colorectal cancer in primary care: the evidence base for guidelines. Fam Pract 2004;21:99106.

  • 3.

    National Institute for Health and Care Excellence. Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care. Accessed February 22, 2022. Available at: https://www.nice.org.uk/guidance/dg30

    • Search Google Scholar
    • Export Citation
  • 4.

    National Institute for Health and Care Excellence. Suspected cancer: recognition and referral. Accessed February 22, 2022. Available at: https://www.nice.org.uk/guidance/ng12

    • Search Google Scholar
    • Export Citation
  • 5.

    van Melle M, Yep Manzano SIS, Wilson H, et al. Faecal immunochemical test to triage patients with abdominal symptoms for suspected colorectal cancer in primary care: review of international use and guidelines. Fam Pract 2020;37:606615.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Westwood M, Corro Ramos I, Lang S, et al. Faecal immunochemical tests to triage patients with lower abdominal symptoms for suspected colorectal cancer referrals in primary care: a systematic review and cost-effectiveness analysis. Health Technol Assess 2017;21:1234.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Fraser CG, Rubeca T, Rapi S, et al. Faecal haemoglobin concentrations vary with sex and age, but data are not transferable across geography for colorectal cancer screening. Clin Chem Lab Med 2014;52:12111216.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 8.

    Digby J, McDonald PJ, Strachan JA, et al. Deprivation and faecal haemoglobin: implications for bowel cancer screening. J Med Screen 2014;21:9597.

  • 9.

    D’Souza N, Abulafi M. The faecal immunochemical test in low risk patients with suspected bowel cancer. Br J Hosp Med (Lond) 2019;80:2226.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 10.

    Saw KS, Liu C, Xu W, et al. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg 2022;109:182190.

  • 11.

    Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527.

  • 12.

    Rutter MD, East J, Rees CJ, et al. British Society of Gastroenterology/ Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines. Gut 2020;69:201223.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Goddard AF, James MW, McIntyre AS, et al. Guidelines for the management of iron deficiency anaemia. Gut 2011;60:13091316.

  • 14.

    Noble S, McLennan D, Noble M, et al. The English Indices of Deprivation 2019: Research Report. Ministry of Housing, Communities and Local Government. London, UK: Ministry of Housing, Communities and Local Government; 2019.

    • Search Google Scholar
    • Export Citation
  • 15.

    GBD 2017 Colorectal Cancer Collaborators. The global, regional, and national burden of colorectal cancer and its attributable risk factors in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol 2019;4:913933.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16.

    Juul JS, Hornung N, Andersen B, et al. The value of using the faecal immunochemical test in general practice on patients presenting with non-alarm symptoms of colorectal cancer. Br J Cancer 2018;119:471479.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17.

    Nicholson BD, James T, Paddon M, et al. Faecal immunochemical testing for adults with symptoms of colorectal cancer attending English primary care: a retrospective cohort study of 14 487 consecutive test requests. Aliment Pharmacol Ther 2020;52:10311041.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18.

    Bailey SER, Abel GA, Atkins A, et al. Diagnostic performance of a faecal immunochemical test for patients with low-risk symptoms of colorectal cancer in primary care: an evaluation in the south west of England. Br J Cancer 2021;124:12311236.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    Laszlo HE, Seward E, Ayling RM, et al. Faecal immunochemical test for patients with ‘high-risk’ bowel symptoms: a large prospective cohort study and updated literature review. Br J Cancer 2022;126:736743.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20.

    Potter C. GP referral thresholds raised to include mandatory FIT tests. Pulse. May 26, 2021. Accessed February 22, 2022. Available at: https://www.pulsetoday.co.uk/news/clinical-areas/cancer/gp-referral-thresholds-raised-to-include-mandatory-fit-tests/

    • Search Google Scholar
    • Export Citation
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 837 837 837
PDF Downloads 524 524 524
EPUB Downloads 0 0 0