Direct Comparison of Diagnostic Performance of 9 Quantitative Fecal Immunochemical Tests for Colorectal Cancer Screening

Gies, Anton; Ćuk, Katarina; Schrotz‐King, Petra; Brenner, Hermann

doi:10.1053/j.gastro.2017.09.018

Cited by 97 publications

(108 citation statements)

References 25 publications

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“…Various FIT devices have been trialled and it has become evident that there is considerable heterogeneity in FIT devices for the O339 detection of CRC. This is further compounded by the fact that various threshold levels are applied and there is uncertainty surrounding those who test negative with FIT [15]. In the UK, CRC detection based on symptoms alone is low; ranging from 4% to 8% [16,17].…”

Section: Discussionmentioning

confidence: 99%

Risk stratification of symptomatic patients suspected of colorectal cancer using faecal and urinary markers

et al. 2018

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Aim Faecal markers, such as the faecal immunochemical test for haemoglobin (FIT) and faecal calprotectin (FCP), have been increasingly used to exclude colorectal cancer (CRC) and colonic inflammation. However, in those with lower gastrointestinal symptoms there are considerable numbers who have cancer but have a negative FIT test (i.e. false negative), which has impeded its use in clinical practice. We undertook a study of diagnostic accuracy CRC using FIT, FCP and urinary volatile organic compounds (VOCs) in patients with lower gastrointestinal symptoms. Method One thousand and sixteen symptomatic patients with suspected CRC referred by family physicians were recruited prospectively in accordance with national referring protocol. A total of 562 patients who completed colonic investigations, in addition to providing stool for FIT and FCP as well as urine samples for urinary VOC measurements, were included in the final outcome measures. Results The sensitivity and specificity for CRC using FIT was 0.80 [95% confidence interval (CI) 0.66–0.93] and 0.93 (CI 0.91–0.95), respectively. For urinary VOCs, the sensitivity and specificity for CRC was 0.63 (CI 0.46–0.79) and 0.63 (CI 0.59–0.67), respectively. However, for those who were FIT‐negative CRC (i.e. false negatives), the addition of urinary VOCs resulted in a sensitivity of 0.97 (CI 0.90–1.0) and specificity of 0.72 (CI 0.68–0.76). Conclusions When applied to the FIT‐negative group, urinary VOCs improve CRC detection (sensitivity rises from 0.80 to 0.97), thus showing promise as a second‐stage test to complement FIT in the detection of CRC.

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Section: Discussionmentioning

confidence: 99%

Risk stratification of symptomatic patients suspected of colorectal cancer using faecal and urinary markers

et al. 2018

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“…However, given the lack of test performance data for the most commonly used test among these providers (InSure), the need for better population‐based test performance information and communication of that information to providers is apparent. Although several well‐controlled comparisons of FIT performance have been reported, the need for performance assessment in real‐world clinical settings has been noted (eg, Ref ). Forecasting colonoscopy burden depends on reliable estimates of expected positivity rate.…”

Section: Discussionmentioning

confidence: 99%

“…Despite advances in the accuracy of fecal tests, FP results outnumber true‐positive (TP) results. Factors affecting FP include choice of FIT, number of samples collected per screening round, and—for quantitative FITs—hemoglobin concentration threshold for determining a positive test . Varying the concentration of hemoglobin used as a threshold for positivity at values between 25 ng/mL and 200 ng/mL using an OC‐Micro system can result in FIT positivity rates that range from 18% to 5%, which has substantial influence on follow‐up colonoscopy demand .…”

Section: Introductionmentioning

confidence: 99%

“…Factors affecting FP include choice of FIT, number of samples collected per screening round, and-for quantitative FITs-hemoglobin concentration threshold for determining a positive test. 15,16 Varying the concentration of hemoglobin used as a threshold for positivity at values between 25 ng/mL and 200 ng/mL using an OC-Micro system can result in FIT positivity rates that range from 18% to 5%, 17,18 which has substantial influence on follow-up colonoscopy demand. 19 Even at the same threshold for positivity, test brand may affect sensitivity and positive predictive value (PPV).…”

Section: Introductionmentioning

confidence: 99%

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Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial

et al. 2018

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Annual fecal immunochemical testing (FIT) is cost‐effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false‐positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed‐FIT outreach, clinics delivered one of three FIT brands (InSure, OC‐Micro, and Hemosure). Patients who had a positive FIT result and a follow‐up colonoscopy were included in this analysis (N = 1130). Patients’ demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow‐up colonoscopy) were evaluated for FIT brand and patient factors using mixed‐effects multivariable logistic regression. The mean proportion of FIT‐positive results ranged from 8% in centers using the OC‐Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for χ 2 = 0.08). In multivariable‐adjusted models, use of Hemosure was associated with greater odds of a FP result than OC‐Micro (OR = 2.00, 95% CI: 0.47‐8.56) or InSure (OR = 1.72, 95% CI: 0.44‐6.68). However, only female sex (OR = 1.58, 95% CI: 1.19‐2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13‐4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.

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“…There are a large number of FIT on the market; many of these are qualitative tests with very little evidence to support their use in any clinical setting. There are an increasing number of quantitative FIT analytical approaches on the market, mainly designed for CRC screening,23 and four of these were subject to an independent analytical evaluation that ratified their potential use in the diagnosis of SBD 24…”

Section: Analytical Considerationsmentioning

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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Direct Comparison of Diagnostic Performance of 9 Quantitative Fecal Immunochemical Tests for Colorectal Cancer Screening

Cited by 97 publications

References 25 publications

Risk stratification of symptomatic patients suspected of colorectal cancer using faecal and urinary markers

Risk stratification of symptomatic patients suspected of colorectal cancer using faecal and urinary markers

Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial

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

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