Finding the needle in the haystack; the diagnostic accuracy of the faecal immunochemical test for colorectal cancer in younger symptomatic patients

ObjectiveTo assess whether a faecal immunochemical test (FIT) could be used to select patients with suspected colorectal cancer (CRC) symptoms for urgent investigation.DesignMulticentre, double-blinded diagnostic accuracy study in 50 National Health Service (NHS) hospitals across England between October 2017 and December 2019. Patients referred to secondary care with suspected CRC symptoms meeting NHS England criteria for urgent 2 weeks wait referral and triaged to investigation with colonoscopy were invited to perform a quantitative FIT. The sensitivity of FIT for CRC, and effect of relevant variables on its diagnostic accuracy was assessed.Results9822 patients were included in the final analysis. The prevalence of CRC at colonoscopy was 3.3%. The FIT positivity decreased from 37.2% to 19.0% and 7.6%, respectively, at cut-offs of 2, 10 and 150 µg haemoglobin/g faeces (µg/g). The positive predictive values of FIT for CRC at these cut-offs were 8.7% (95% CI, 7.8% to 9.7%), 16.1% (95% CI 14.4% to 17.8%) and 31.1% (95% CI 27.8% to 34.6%), respectively, and the negative predictive values were 99.8% (95% CI 99.7% to 99.9%), 99.6% (95% CI 99.5% to 99.7%) and 98.9% (95% CI 98.7% to 99.1%), respectively. The sensitivity of FIT for CRC decreased at the same cut-offs from 97.0% (95% CI 94.5% to 98.5%) to 90.9% (95% CI 87.2% to 93.8%) and 70.8% (95% CI 65.6% to 75.7%), respectively, while the specificity increased from 64.9% (95% CI 63.9% to 65.8%) to 83.5% (95% CI 82.8% to 84.3%) and 94.6% (95% CI 94.1% to 95.0%), respectively. The area under the receiver operating characteristic curve was 0.93 (95% CI 0.92 to 0.95).ConclusionFIT sensitivity is maximised to 97.0% at the lowest cut-off (2 µg/g); a negative FIT result at this cut-off can effectively rule out CRC and a positive FIT result is better than symptoms to select patients for urgent investigations.Trial registration numberISRCTN49676259.

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The diagnostic accuracy of the faecal immunochemical test for colorectal cancer in risk-stratified symptomatic patients

Annals of The Royal College of Surgeons of England ◽

10.1308/rcsann.2019.0144 ◽

2020 ◽

Vol 102 (3) ◽

pp. 174-179 ◽

Cited By ~ 5

Author(s):

N D’Souza ◽

G Hicks ◽

SC Benton ◽

M Abulafi

Keyword(s):

Colorectal Cancer ◽

Pilot Study ◽

Diagnostic Accuracy ◽

Significant Variation ◽

Detection Rate ◽

Low Risk ◽

Faecal Immunochemical Test ◽

Risk Patients ◽

Immunochemical Test ◽

Rule Out

Introduction The faecal immunochemical test detects blood in the faeces, reporting faecal haemoglobin quantitatively in micrograms of haemoglobin per gram of faeces. The aim of this pilot study was to determine the feasibility of using the faecal immunochemical test as a rule-out test in symptomatic patients at low and high risk of colorectal cancer. Material and methods Between November 2016 and October 2017, consecutive symptomatic patients within a multicultural part of London were recruited to perform a faecal immunochemical test prior to colonoscopy. Analysis was performed on the HM-JACKarc analyser. Results Faecal immunochemical test samples were returned by 298 patients who underwent colonoscopy. There was no significant variation in faecal haemoglobin levels by age, sex, ethnicity or deprivation. The overall detection rate for colorectal cancer was 100% at 2 µg/g and 92% at 10 µg/g. If a faecal haemoglobin threshold for investigation of 2 µg/g (ie detectable) or 10 µg/g had been employed, the number of colonoscopies would have been reduced by 70% and 84%, respectively, in all symptomatic patients. For low-risk patients, the sensitivity of the faecal immunochemical test for colorectal cancer at both thresholds of 2 µg/g or 10 µg/g remained 100%, with the number of colonoscopies reduced by 80% and 91%, respectively. Conclusion This study shows that the faecal immunochemical test is a promising technology that detected colorectal cancer in all high- or low-risk symptomatic patients in our cohort at a threshold of detectable faecal haemoglobin. Data from adequately powered cohort studies will elucidate the true diagnostic accuracy of the test and the rate and patterns of undetected colorectal cancer.

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Diagnostic accuracy of faecal immunochemical test for screening individuals with a family history of colorectal cancer

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.12446 ◽

2013 ◽

Vol 38 (7) ◽

pp. 835-841 ◽

Cited By ~ 29

Author(s):

S. C. Ng ◽

J. Y. L. Ching ◽

V. Chan ◽

M. C. S. Wong ◽

B. Y. Suen ◽

...

Keyword(s):

Colorectal Cancer ◽

Family History ◽

Diagnostic Accuracy ◽

Faecal Immunochemical Test ◽

History Of ◽

Immunochemical Test

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The Fast Track FIT study: diagnostic accuracy of faecal immunochemical test for haemoglobin in patients with suspected colorectal cancer

British Journal of General Practice ◽

10.3399/bjgp.2020.1098 ◽

2021 ◽

pp. BJGP.2020.1098

Author(s):

James Turvill ◽

Daniel Turnock ◽

Dan Cottingham ◽

Monica Haritakis ◽

Laura Jeffery ◽

...

Keyword(s):

Colorectal Cancer ◽

Diagnostic Accuracy ◽

Predictive Value ◽

Final Diagnosis ◽

Care Providers ◽

Operating Characteristics ◽

Faecal Immunochemical Test ◽

Characteristics Analysis ◽

Bowel Cancer Screening ◽

Immunochemical Test

Background: The faecal immunochemical test (FIT) is now available to support clinicians in the assessment of patients at low risk of colorectal cancer (CRC) and within the Bowel Cancer Screening Programme. Aim: To determine the diagnostic accuracy of FIT for CRC and clinically significant disease in patients referred because they were judged by their GP to fulfil NICE NG12 criteria for suspected CRC. Design and Setting: Patients referred from primary care with suspected CRC, meeting NG12 criteria, to 12 secondary care providers in Yorkshire and Humber were asked to complete a FIT prior to investigation. Method: The diagnostic accuracy of FIT based upon final diagnosis was evaluated using receiver operating characteristics analysis. Clinicians and patients were blinded to the FIT results. Results: 5040 patients were fully evaluated and CRC was detected in 151 (3%). An optimal cut-off value of 19 g Hb/g faeces for CRC was determined, giving a sensitivity of 85.4% (78.8-90.6%) and specificity of 85.2% (84.1-86.2%). The negative predictive value at this cut-off value was 99.5% (99.2-99.7%) and the positive predictive value 15.1% (12.8-17.7%). Sensitivity and specificity of FIT for CRC and significant premalignant polyps at this cut-off value were 62.9% (57.5-68.0%) and 86.4% (85.4-87.4%) respectively and when including all organic enteric disease were 35.7% (32.9-38.5%) and 88.6% (87.5-89.6%). Conclusions: FIT used in patients fulfilling NICE NG12 criteria should allow for a more personalised CRC risk assessment. FIT should permit effective, patient-centred decision-making to inform the need for, type and timing of further investigation.

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Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria

Colorectal Disease ◽

10.1111/codi.12569 ◽

2014 ◽

Vol 16 (8) ◽

pp. O273-O282 ◽

Cited By ~ 50

Author(s):

J. Cubiella ◽

M. Salve ◽

M. Díaz-Ondina ◽

P. Vega ◽

M. T. Alves ◽

...

Keyword(s):

Colorectal Cancer ◽

Diagnostic Accuracy ◽

Faecal Immunochemical Test ◽

Referral Criteria ◽

Immunochemical Test

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Individualized Faecal Immunochemical Test Cut-off based on Age and Sex in Colorectal Cancer Screening

Preventive Medicine Reports ◽

10.1016/j.pmedr.2021.101447 ◽

2021 ◽

pp. 101447

Author(s):

Tim L. Kortlever ◽

Manon van der Vlugt ◽

Evelien Dekker ◽

Patrick M.M. Bossuyt

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Faecal Immunochemical Test ◽

Immunochemical Test ◽

Age And Sex

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Choice of faecal immunochemical test matters: comparison of OC-Sensor and HM-JACKarc, in the assessment of patients at high risk of colorectal cancer

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1170 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Caroline J. Chapman ◽

Ayan Banerjea ◽

David J Humes ◽

Jaren Allen ◽

Simon Oliver ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Decision Making ◽

Full Range ◽

Clinical Decision ◽

Detection Rates ◽

Faecal Immunochemical Test ◽

Specimen Collection ◽

Increased Risk ◽

Immunochemical Test

AbstractObjectivesCurrently, NICE recommends the use of faecal immunochemical test (FIT) at faecal haemoglobin concentrations (f-Hb) of 10 μg Hb/g faeces to stratify for colorectal cancer (CRC) risk in symptomatic populations. This f-Hb cut-off is advised across all analysers, despite the fact that a direct comparison of analyser performance, in a clinical setting, has not been performed.MethodsTwo specimen collection devices (OC-Sensor, OC-S; HM-JACKarc, HM-J) were sent to 914 consecutive individuals referred for follow up due to their increased risk of CRC. Agreement of f-Hb around cut-offs of 4, 10 and 150 µg Hb/g faeces and CRC detection rates were assessed. Two OC-S devices were sent to a further 114 individuals, for within test comparisons.ResultsA total of 732 (80.1%) individuals correctly completed and returned two different FIT devices, with 38 (5.2%) CRCs detected. Median f-Hb for individuals diagnosed with and without CRC were 258.5 and 1.8 µg Hb/g faeces for OC-S and 318.1 and 1.0 µg Hb/g faeces for HM-J respectively. Correlation of f-Hb results between OC-S/HM-J over the full range was rho=0.74, p<0.001. Using a f-Hb of 4 µg Hb/g faeces for both tests found an agreement of 88.1%, at 10 µg Hb/g faeces 91.7% and at 150 µg Hb/g faeces 96.3%. A total of 114 individuals completed and returned two OC-S devices; correlation across the full range was rho=0.98, p<0.001.ConclusionsWe found large variations in f-Hb when different FIT devices were used, but a smaller variation when the same FIT device was used. Our data suggest that analyser-specific f-Hb cut-offs are applied with regard to clinical decision making, especially at lower f-Hb.

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