Faecal immunochemical tests for patients with symptoms suggestive of colorectal cancer: an updated systematic review and multiple-threshold meta-analysis of diagnostic test accuracy studies
Author(s)
Type
Journal Article
Abstract
Aim
Extending faecal immunochemical tests for haemoglobin (FIT) to all primary care patients with symptoms suggestive of colorectal cancer (CRC) could identify people who are likely to benefit from colonoscopy and facilitate earlier treatment. The aim of this work was to investigate the diagnostic accuracy of FIT across different analysers at different thresholds, as a single test or in duplicate (dual FIT).
Method
This systematic review and meta-analysis searched 10 sources (December 2022). Diagnostic accuracy studies of HM-JACKarc, OC-Sensor, FOB Gold, QuikRead go, NS-Prime and four Immunodiagnostik (IDK) tests in primary care patients were included. Risk of bias was assessed (QUADAS-2). Statistical syntheses produced summary estimates of sensitivity and specificity at any chosen threshold for CRC, inflammatory bowel disease and advanced adenomas separately. Sensitivity analyses investigated reference standard and population type (high, low or all-risk). Subgroup analyses investigated patient characteristics (e.g. anaemia, age, sex, ethnicity).
Results
Thirty-seven studies were included. At a threshold of 10 μg/g, pooled results for sensitivity and specificity (95% credible intervals) for CRC, respectively, were: HM-JACKarc (n = 16 studies) 89.5% (84.6%–93.4%) and 82.8% (75.2%–89.6%); OC-Sensor (n = 11 studies) 89.8% (85.9%–93.3%) and 77.6% (64.3%–88.6%); FOB Gold (n = 3 studies), 87.0% (67.3%–98.3%) and 88.4% (81.7%–94.2%). There were limited or no data on the other tests, dual FIT and relating to patient characteristics.
Conclusion
Test sensitivity at a threshold of 10 μg/g highlights a requirement for adequate safeguards in test-negative patients with ongoing symptoms. Further research is needed into the impact of patient characteristics and dual FIT.
What does this paper add to the literature?
This systematic review of faecal immunochemical tests informed the NICE NG12 guideline update in 2023. We synthesized accuracy across thresholds in a single analysis. Accuracy at 10 μg/g in primary care patients with NG12 signs/symptoms indicates far fewer referrals with few missed cancers. Thus, safety netting is required.
Extending faecal immunochemical tests for haemoglobin (FIT) to all primary care patients with symptoms suggestive of colorectal cancer (CRC) could identify people who are likely to benefit from colonoscopy and facilitate earlier treatment. The aim of this work was to investigate the diagnostic accuracy of FIT across different analysers at different thresholds, as a single test or in duplicate (dual FIT).
Method
This systematic review and meta-analysis searched 10 sources (December 2022). Diagnostic accuracy studies of HM-JACKarc, OC-Sensor, FOB Gold, QuikRead go, NS-Prime and four Immunodiagnostik (IDK) tests in primary care patients were included. Risk of bias was assessed (QUADAS-2). Statistical syntheses produced summary estimates of sensitivity and specificity at any chosen threshold for CRC, inflammatory bowel disease and advanced adenomas separately. Sensitivity analyses investigated reference standard and population type (high, low or all-risk). Subgroup analyses investigated patient characteristics (e.g. anaemia, age, sex, ethnicity).
Results
Thirty-seven studies were included. At a threshold of 10 μg/g, pooled results for sensitivity and specificity (95% credible intervals) for CRC, respectively, were: HM-JACKarc (n = 16 studies) 89.5% (84.6%–93.4%) and 82.8% (75.2%–89.6%); OC-Sensor (n = 11 studies) 89.8% (85.9%–93.3%) and 77.6% (64.3%–88.6%); FOB Gold (n = 3 studies), 87.0% (67.3%–98.3%) and 88.4% (81.7%–94.2%). There were limited or no data on the other tests, dual FIT and relating to patient characteristics.
Conclusion
Test sensitivity at a threshold of 10 μg/g highlights a requirement for adequate safeguards in test-negative patients with ongoing symptoms. Further research is needed into the impact of patient characteristics and dual FIT.
What does this paper add to the literature?
This systematic review of faecal immunochemical tests informed the NICE NG12 guideline update in 2023. We synthesized accuracy across thresholds in a single analysis. Accuracy at 10 μg/g in primary care patients with NG12 signs/symptoms indicates far fewer referrals with few missed cancers. Thus, safety netting is required.
Date Issued
2025-01
Date Acceptance
2024-10-18
Citation
Colorectal Disease, 2025, 27 (1)
ISSN
1462-8910
Publisher
Wiley
Journal / Book Title
Colorectal Disease
Volume
27
Issue
1
Copyright Statement
© 2024 The Author(s). Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://onlinelibrary.wiley.com/doi/10.1111/codi.17255
Subjects
adenomas
CARE
colorectal cancer
diagnostic test accuracy
faecal immunochemical test
Gastroenterology & Hepatology
HEMOGLOBIN
inflammatory bowel disease
Life Sciences & Biomedicine
primary care
Science & Technology
Surgery
systematic review
Publication Status
Published
Article Number
e17255
Date Publish Online
2024-12-17