Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 21, 2019; 25(19): 2383-2401
Published online May 21, 2019. doi: 10.3748/wjg.v25.i19.2383
High-risk symptoms and quantitative faecal immunochemical test accuracy: Systematic review and meta-analysis
Noel Pin Vieito, Sara Zarraquiños, Joaquín Cubiella
Noel Pin Vieito, Sara Zarraquiños, Joaquín Cubiella, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Ourense 32005, Spain
Noel Pin Vieito, Sara Zarraquiños, Joaquín Cubiella, Instituto de Investigación Sanitaria Galicia Sur, Ourense 32005, Spain
Noel Pin Vieito, Department of Biochemistry, Genetics and Immunology, Faculty of Biology University of Vigo, Vigo 36310, Pontevedra, Spain
Author contributions: Pin Vieito N and Cubiella J conception and design of the study; Pin Vieito N, Zarraquiños S, and Cubiella J acquisition of data, analysis and interpretation of data, and final approval; Pin Vieito N and Cubiella J drafted the article; Cubiella J contributed to critical revision.
Conflict-of-interest statement: Dr. Pin reports non-financial support from ABBVIE, non-financial support from GILEAD SCIENCES, outside the submitted work; Dr. Zarraquiños reports non-financial support from CASEN RECORDATI, non-financial support from MYLAN, non-financial support from ALLERGAN, non-financial support from OLYMPUS, non-financial support from ABBVIE, outside the submitted work; Dr. Cubiella reports grants from Instituto de Investigación Sanitaria Galicia Sur, grants from Fondo de Investigaciones Sanitarias (FIS), during the conduct of the study; personal fees from NORGINE, personal fees from IMC, outside the submitted work;
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Noel Pin Vieito, MD, Staff Physician, Statistician, Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, C/ Ramón Puga 52-54, Ourense 32005, Spain.
Telephone: +34-988385399 Fax: +34-988385399
Received: February 3, 2019
Peer-review started: February 6, 2019
First decision: March 5, 2019
Revised: March 20, 2019
Accepted: March 29, 2019
Article in press: March 30, 2019
Published online: May 21, 2019

The quantitative faecal immunochemical test for haemoglobin (FIT) has been revealed to be highly accurate for colorectal cancer (CRC) detection not only in a screening setting, but also in the assessment of patients presenting lower bowel symptoms. Therefore, the National Institute for Health and Care Excellence has recommended the adoption of FIT in primary care to guide referral for suspected CRC in low-risk symptomatic patients using a 10 µg Hb/g faeces threshold. Nevertheless, it is unknown whether FIT´s accuracy remains stable throughout the broad spectrum of possible symptoms.


To perform a systematic review and meta-analysis to assess FIT accuracy for CRC detection in different clinical settings.


A systematic literature search was performed using MEDLINE and EMBASE databases from inception to May 2018 to conduct a meta-analysis of prospective studies including symptomatic patients that evaluated the diagnostic accuracy of quantitative FIT for CRC detection. Studies were classified on the basis of brand, threshold of faecal haemoglobin concentration for a positive test result, percentage of reported symptoms (solely symptomatic, mixed cohorts) and CRC prevalence (< 2.5%, ≥ 2.5%) to limit heterogeneity and perform subgroup analysis to assess the influence of clinical spectrum on FIT´s accuracy to detect CRC.


Fifteen cohorts including 13073 patients (CRC prevalence 0.4% to 16.8%) were identified. Pooled estimates of sensitivity for studies using OC-Sensor at 10 µg Hb/g faeces threshold (n = 10400) was 89.6% [95% confidence interval (CI): 82.7% to 94.0%). However, pooled estimates of sensitivity for studies formed solely by symptomatic patients (n = 4035) and mixed cohorts (n = 6365) were 94.1% (95%CI: 90.0% to 96.6%) and 85.5% (95%CI: 76.5% to 91.4%) respectively (P < 0.01), while there were no statistically significant differences between pooled sensitivity of studies with CRC prevalence < 2.5% (84.9%, 95%CI: 73.4% to 92.0%) and ≥ 2.5% (91.7%, 95%CI: 83.3% to 96.1%) (P = 0.25). At the same threshold, OC-Sensor® sensitivity to rule out any significant colonic lesion was 78.6% (95%CI: 75.6% to 81.4%). We found substantial heterogeneity especially when assessing specificity.


The results of this meta-analysis confirm that, regardless of CRC prevalence, quantitative FIT is highly sensitive for CRC detection. However, FIT ability to rule out CRC is higher in studies solely including symptomatic patients.

Keywords: Bowel disease, Colorectal cancer, Diagnostic accuracy, Faecal haemoglobin, Faecal immunochemical test, Faecal occult blood test, Inflammatory bowel disease, Significant colonic lesion

Core tip: The quantitative faecal immunochemical test for haemoglobin (FIT) has been recommended to guide referral for suspected colorectal cancer (CRC) in people with unexplained symptoms without rectal bleeding. However, the information regarding its accuracy in different settings is scarce. Our meta-analysis reveals that sensitivity for CRC may change across populations with differences in clinical symptoms, irrespective of CRC prevalence. On the other hand, we should not use this to rule out CRC if its prevalence is high. In addition, FIT is not sensitive enough to exclude other significant colonic diseases.