Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis

Abstract Background This review evaluated the utility of single quantitative faecal immunochemical test (FIT) as a triaging tool for patients with symptoms of possible colorectal cancer, the effect of symptoms on FIT accuracy, and the impact of triaging incorporating FIT on service provision. Methods Five databases were searched. Meta-analyses of the extracted FIT sensitivities and specificities for detection of colorectal cancer at reported f-Hb thresholds were performed. Secondary outcomes included sensitivity and specificity of FIT for advanced colorectal neoplasia and serious bowel disease. Subgroup analysis by FIT brand and symptoms was undertaken. Results Fifteen prospective cohort studies, including 28 832 symptomatic patients were included. At the most commonly reported f-Hb positivity threshold of ≥ 10 µg Hb/g faeces (n=13), the summary sensitivity was 88.7% (95% c.i. 85.2 to 91.4) and the specificity was 80.5% (95% c.i. 75.3 to 84.8) for colorectal cancer. At lower limits of detection of ≥ 2 µg Hb/g faeces, the summary sensitivity was 96.8% (95% c.i. 91.0 to 98.9) and the specificity was 65.6% (95% c.i. 59.0 to 71.6). At the upper f-Hb positivity thresholds of ≥ 100 µg Hb/g faeces and ≥ 150 µg Hb/g faeces, summary sensitivities were 68.1% (95% c.i. 59.2 to 75.9) and 66.3% (95% c.i. 52.2 to 78.0), with specificities of 93.4% (95% c.i. 91.3 to 95.1) and 95.1% (95% c.i. 93.6 to 96.3) respectively. FIT sensitivity was comparable between different assay brands. FIT sensitivity may be higher in patients reporting rectal bleeding. Conclusion Single quantitative FIT at lower f-Hb positivity thresholds can adequately exclude colorectal cancer in symptomatic patients and provides a data-based approach to prioritization of colonoscopy resources.

[1]  Hassan Al-haj Ibrahim,et al.  Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population , 2021, Techniques in Coloproctology.

[2]  T. Rockall,et al.  Diagnostic accuracy of point of care faecal immunochemical testing using a portable high‐speed quantitative analyser for diagnosis in 2‐week wait patients , 2021, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[3]  J. Turvill,et al.  The Fast Track FIT study: diagnostic accuracy of faecal immunochemical test for haemoglobin in patients with suspected colorectal cancer , 2021, The British journal of general practice : the journal of the Royal College of General Practitioners.

[4]  D. Humes,et al.  Faecal immunochemical testing and blood tests for prioritization of urgent colorectal cancer referrals in symptomatic patients: a 2-year evaluation , 2021, BJS open.

[5]  E. Symonds,et al.  Faecal Immunochemical Tests for Haemoglobin: Analytical Challenges and Potential Solutions. , 2021, Clinica chimica acta; international journal of clinical chemistry.

[6]  I. Lansdorp-Vogelaar,et al.  Impact of the COVID-19 pandemic on faecal immunochemical test-based colorectal cancer screening programmes in Australia, Canada, and the Netherlands: a comparative modelling study , 2021, The Lancet Gastroenterology & Hepatology.

[7]  C. Mowat,et al.  Faecal haemoglobin concentration thresholds for reassurance and urgent investigation for colorectal cancer based on a faecal immunochemical test in symptomatic patients in primary care , 2020, Annals of clinical biochemistry.

[8]  D. Humes,et al.  Choice of faecal immunochemical test matters: comparison of OC-Sensor and HM-JACKarc, in the assessment of patients at high risk of colorectal cancer , 2020, Clinical chemistry and laboratory medicine.

[9]  M. Abulafi,et al.  Faecal immunochemical test is superior to symptoms in predicting pathology in patients with suspected colorectal cancer symptoms referred on a 2WW pathway: a diagnostic accuracy study , 2020, Gut.

[10]  A. A. Khan,et al.  Accuracy of faecal immunochemical testing in patients with symptomatic colorectal cancer , 2020, BJS open.

[11]  E. Mayo-Wilson,et al.  The PRISMA 2020 statement: an updated guideline for reporting systematic reviews , 2020, BMJ.

[12]  Á. Lanas,et al.  Reducing the Cut-Off Value of the Fecal Immunochemical Test for Symptomatic Patients Does Not Improve Diagnostic Performance , 2020, Frontiers in Medicine.

[13]  J. Cubiella,et al.  Optimal diagnostic accuracy of quantitative faecal immunochemical test positivity thresholds for colorectal cancer detection in primary health care: A community‐based cohort study , 2020, United European gastroenterology journal.

[14]  Zhi‐Jie Zheng,et al.  Differences in Incidence and Mortality Trends of Colorectal Cancer, Worldwide, Based on Sex, Age, and Anatomic Location. , 2020, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[15]  P. Hellström,et al.  Diagnostic accuracy of a quantitative faecal immunochemical test vs. symptoms suspected for colorectal cancer in patients referred for colonoscopy , 2020, Scandinavian journal of gastroenterology.

[16]  J. Morling,et al.  Early clinical outcomes of a rapid colorectal cancer diagnosis pathway using faecal immunochemical testing in Nottingham , 2019, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[17]  M. Abulafi,et al.  The diagnostic accuracy of the faecal immunochemical test for colorectal cancer in risk-stratified symptomatic patients. , 2019, Annals of the Royal College of Surgeons of England.

[18]  J. Cubiella,et al.  High-risk symptoms and quantitative faecal immunochemical test accuracy: Systematic review and meta-analysis , 2019, World journal of gastroenterology.

[19]  R. Arasaradnam,et al.  Faecal immunochemical testing (FIT) in symptomatic patients: what are we missing? , 2019, Frontline Gastroenterology.

[20]  C. Mowat,et al.  Impact of introducing a faecal immunochemical test (FIT) for haemoglobin into primary care on the outcome of patients with new bowel symptoms: a prospective cohort study , 2019, BMJ open gastroenterology.

[21]  U. Uthman,et al.  Systematic review and meta-analysis : diagnostic accuracy of faecal immunochemical testing for haemoglobin (FIT) in detecting colorectal cancer for both symptomatic and screening population. , 2019, Acta gastro-enterologica Belgica.

[22]  F. Cotter,et al.  Potential roles of artificial intelligence learning and faecal immunochemical testing for prioritisation of colonoscopy in anaemia , 2019, British Journal of Haematology.

[23]  D. Humes,et al.  Service evaluation of faecal immunochemical testing and anaemia for risk stratification in the 2‐week‐wait pathway for colorectal cancer , 2019, BJS open.

[24]  C. Fraser Faecal immunochemical tests (FIT) in the assessment of patients presenting with lower bowel symptoms: Concepts and challenges. , 2018, The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland.

[25]  J. Cubiella,et al.  Effect of aspirin on the diagnostic accuracy of the faecal immunochemical test for colorectal advanced neoplasia , 2018, United European gastroenterology journal.

[26]  C. Fraser,et al.  Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms , 2016, Clinical chemistry and laboratory medicine.

[27]  David H. Murray,et al.  A Blood Test for Methylated BCAT1 and IKZF1 vs. a Fecal Immunochemical Test for Detection of Colorectal Neoplasia , 2016, Clinical and Translational Gastroenterology.

[28]  J. Cubiella,et al.  Colorectal cancer diagnosis: Pitfalls and opportunities. , 2015, World journal of gastrointestinal oncology.

[29]  V. Moreno,et al.  An urgent referral strategy for symptomatic patients with suspected colorectal cancer based on a quantitative immunochemical faecal occult blood test. , 2015, Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver.

[30]  C. Mowat,et al.  Faecal haemoglobin and faecal calprotectin as indicators of bowel disease in patients presenting to primary care with bowel symptoms , 2015, Gut.

[31]  C. Mathers,et al.  Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012 , 2015, International journal of cancer.

[32]  Susan Mallett,et al.  QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies , 2011, Annals of Internal Medicine.

[33]  M. Leeflang,et al.  Cochrane diagnostic test accuracy reviews , 2013, Systematic Reviews.

[34]  P. McDonald,et al.  Low faecal haemoglobin concentration potentially rules out significant colorectal disease , 2013, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[35]  A. Zullo,et al.  A combination of faecal tests for the detection of colon cancer: a new strategy for an appropriate selection of referrals to colonoscopy? A prospective multicentre Italian study , 2012, European journal of gastroenterology & hepatology.

[36]  Les Irwig,et al.  Most bowel cancer symptoms do not indicate colorectal cancer and polyps: a systematic review , 2011, BMC gastroenterology.

[37]  Steve Halligan,et al.  Colorectal cancer: CT colonography and colonoscopy for detection--systematic review and meta-analysis. , 2011, Radiology.

[38]  G. Meijer,et al.  Higher Fecal Immunochemical Test Cutoff Levels: Lower Positivity Rates but Still Acceptable Detection Rates for Early-Stage Colorectal Cancers , 2010, Cancer Epidemiology, Biomarkers & Prevention.

[39]  A. Verbeek,et al.  Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme , 2009, British Journal of Cancer.

[40]  Johannes B Reitsma,et al.  Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. , 2005, Journal of clinical epidemiology.

[41]  Jonathan J Deeks,et al.  The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed. , 2005, Journal of clinical epidemiology.

[42]  Dirk Schrijvers,et al.  The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. , 2004, European journal of cancer.

[43]  D. Altman,et al.  Measuring inconsistency in meta-analyses , 2003, BMJ : British Medical Journal.

[44]  J. Morling,et al.  FIT increases the proportion of Colorectal Cancers detected on urgent pathways in symptomatic patients in Nottingham , 2020 .

[45]  J. Kleijnen,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. , 2017, Health technology assessment.

[46]  A. Castells,et al.  Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients , 2016, Clinical chemistry and laboratory medicine.