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

Godber, Ian M; Todd, Louise M; Fraser, Callum G.; MacDonald, Linda R; Younes, Hakim Ben

doi:10.1515/cclm-2015-0617

Cited by 59 publications

(105 citation statements)

References 6 publications

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“…FIT has recently been evaluated for CRC diagnosis in symptomatic patients and compared with available referral criteria. The available studies show that FIT has a high diagnostic accuracy for CRC detection and our results confirm these findings [8, 15–18]. In fact, the COLONPREDICT score is the first FIT-based CRC prediction model in this setting.…”

Section: Discussionsupporting

confidence: 87%

“…Nowadays, there are several potential biomarkers available that could be used to determine the risk of CRC detection in symptomatic patients. A faecal immunochemical test (FIT) has proven to be a useful diagnostic test both for CRC screening in asymptomatic individuals and for diagnosis in symptomatic patients [8, 14–18]. Semiquantitative FIT allows for quantification of faecal haemoglobin (f-Hb) concentration.…”

Section: Introductionmentioning

confidence: 99%

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Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients

Cubiella

Vega

Salve

et al. 2016

BMC Med

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BackgroundRisk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables.MethodsThis prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome.ResultsWe included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02–1.06), male gender (OR 2.2, 95 % CI 1.5–3.4), faecal haemoglobin ≥20 μg/g (OR 17.0, 95 % CI 10.0–28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2–10.3), blood haemoglobin 10–12 g/dL (OR 1.8, 95 % CI 1.1–3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0–6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2–0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06–0.2), rectal mass (OR 14.8, 95 % CI 5.3–41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2–0.4), rectal bleeding (OR 2.2, 95 % CI 1.4–3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1–2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91–0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55–0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7–45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8–6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0–1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90–0.94; p = 0.7).ConclusionsCOLONPREDICT is a highly accurate prediction model for CRC detection.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0668-5) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients

Cubiella

Vega

Salve

et al. 2016

BMC Med

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“…Added to this, when referral is made into secondary care following a positive FIT result, the quantitative result may allow those with elevated f-Hb more in keeping with malignancy to be triaged effectively8 since f-Hb is directly related to the severity of colorectal disease, with more significant bowel diseases (SBDs) being associated with higher f-Hb 9. Indeed, it has been suggested that the f-Hb could be used to prioritise further investigation, those with higher f-Hb being further investigated sooner 3 4.…”

Section: Introductionmentioning

confidence: 99%

Setting up a service for a faecal immunochemical test for haemoglobin (FIT): a review of considerations, challenges and constraints

2018

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Quantitative faecal immunochemical tests for haemoglobin (FIT) have now been advocated by the National Institute for Care and Health Excellence (NICE: DG30) to assist in the triage of patients presenting with symptoms that suggest a low risk of colorectal (bowel) cancer. The evidence is that FIT provides a good rule out test for significant bowel disease. However, a small number of cases will be missed, and robust safety-netting procedures are required to follow up some FIT-negative patients. A range of diagnostic pathways are possible, and there is no best approach at present. Introduction of FIT requires careful consideration of the logistics of supply of devices and information to requesting sites and of transport to the laboratory. A number of FIT analytical systems are available. Three are documented as appropriate for use in assessment of patients with symptoms. However, preanalytical, analytical and postanalytical challenges remain. The methods have different specimen collection devices. The methods use polyclonal antibodies and there is no primary reference material or method to which FIT methods are standardised. Third-party internal quality control is lacking, and external quality assessment schemes have many difficulties in providing appropriate materials. Reporting of results should be done using µg Hb/g faeces units and with knowledge of the limit of detection and limit of quantitation of the analytical system used. FIT can be used successfully in an agreed diagnostic pathway, along with other clinical and laboratory information: this requires a multidisciplinary approach, providing opportunities for professionals in laboratory medicine involvement.

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“…Furthermore, recent studies have demonstrated that quantitative FIT is also an objective and accurate method for detecting advanced neoplasia (AN), including advanced adenoma and colorectal cancer, in symptomatic patients. In fact, FIT has shown a better discriminatory ability than lower abdominal symptoms [5–9]. Nevertheless, its accuracy in the detection of advanced adenoma (AA) is far from perfect.…”

Section: Introductionmentioning

confidence: 99%

“…Nevertheless, its accuracy in the detection of advanced adenoma (AA) is far from perfect. The sensitivity of the FIT for CRC is relatively high, at over 85%, but its sensitivity for advanced adenoma (AA) is under 40% [9–11]. AA is associated with a relatively high risk of progression to cancer and is considered the optimal target lesion to prevent colorectal cancer [12–14].…”

Section: Introductionmentioning

confidence: 99%

Proton pump inhibitors reduce the accuracy of faecal immunochemical test for detecting advanced colorectal neoplasia in symptomatic patients

et al. 2018

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BackgroundThe faecal immunochemical test (FIT) is used in colorectal cancer (CRC) screening and for the detection of advanced colorectal neoplasia (AN) in symptomatic patients, but its accuracy could be improved. Our objective was to assess the impact of proton pump inhibitors (PPI) on the accuracy of the FIT in the detection of AN, namely advanced colorectal adenoma and CRC.Methods and findingsWe performed a prospective study of 1002 individuals referred for a diagnostic colonoscopy at Bellvitge University Hospital from September 2011 through to October 2012. An exhaustive interview was performed by a gastroenterologist, prescription drug dispensing database was reviewed and the patient was given a FIT prior to colonoscopy. The positivity threshold of FIT used was ≥ 20 μg Hb/g feces and the main outcome was AN. AN was detected in 13.2% (133) of patients. The accuracy of FIT for detecting AN in the PPI users and non-PPI users were: sensitivity 43.0% vs 65.6%, P = 0.009; specificity 86.9% vs 92.3%, P = 0.010; and, predictive positive value 34.4% vs 55.5%, P = 0.007, respectively. In multivariate analysis, adjusting for potential confounders, PPIs were associated with false positives in AN detection by FIT (OR 1.63 CI 95% 1.02–2.59, P < 0.037). The ROC curve for the FIT in the detection of AN in the PPI users and non-PPI users was 0.68 (CI 95% 0.61–0.76) and 0.85 (CI 95% 0.79–0.90).ConclusionsPPI therapy reduces the accuracy of FIT for detecting AN in symptomatic patients.

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

Cited by 59 publications

References 6 publications

Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients

Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients

Setting up a service for a faecal immunochemical test for haemoglobin (FIT): a review of considerations, challenges and constraints

Proton pump inhibitors reduce the accuracy of faecal immunochemical test for detecting advanced colorectal neoplasia in symptomatic patients

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