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

Chapman, Caroline J; Banerjea, Ayan; Humes, David J; Allen, Jaren; Oliver, Simon; Ford, Abby; Hardy, Katie; Djedovic, Natasha; Logan, Richard F; Morling, Joanne R

Abstract

Objectives: Currently 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.

Methods: Two 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.

Results: 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[less than]0.001. Using a f-Hb of 4μg Hb/g faeces for both tests found an agreement of 88.1%, at 10μg Hb/g faeces 91.7% and at 150μg Hb/g faeces 96.3%.

114 individuals completed and returned two OC-S devices; correlation across the full range was rho=0.98, p[less than]0.001.

Conclusion: We 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.

Citation

Chapman, C. J., Banerjea, A., Humes, D. J., Allen, J., Oliver, S., Ford, A., Hardy, K., Djedovic, N., Logan, R. F., & Morling, J. R. (2021). 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, 59(4), 721-728. https://doi.org/10.1515/cclm-2020-1170

• Journal Article Type: Article
• Acceptance Date: Oct 15, 2020
• Online Publication Date: Oct 29, 2020
• Publication Date: Mar 12, 2021
• Deposit Date: Oct 15, 2020
• Publicly Available Date: Oct 30, 2021
• Journal: Clinical Chemistry and Laboratory Medicine (CCLM)
• Print ISSN: 1434-6621
• Electronic ISSN: 1437-4331
• Publisher: De Gruyter
• Peer Reviewed: Peer Reviewed
• Volume: 59
• Issue: 4
• Pages: 721-728
• DOI: https://doi.org/10.1515/cclm-2020-1170
• Keywords: bowel cancer; colorectal cancer; diagnostic accuracy; faecal immunochemical test (FIT); faecal haemoglobin; risk stratification; symptomatic
• Public URL: https://nottingham-repository.worktribe.com/output/4966582
• Publisher URL: https://www.degruyter.com/view/journals/cclm/ahead-of-print/article-10.1515-cclm-2020-1170/article-10.1515-cclm-2020-1170.xml