期刊
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
卷 59, 期 4, 页码 721-728出版社
WALTER DE GRUYTER GMBH
DOI: 10.1515/cclm-2020-1170
关键词
bowel cancer; colorectal cancer; diagnostic accuracy; faecal immunochemical test (FIT); faecal haemoglobin; risk stratification; symptomatic
资金
- National Institute for Health Research
- Medical Research Council [MR/P008348/1]
- MRC [MR/P008348/1] Funding Source: UKRI
The study found large variations in f-Hb when different FIT devices were used, but smaller variation when the same FIT device was used. This suggests that analyzer-specific f-Hb cut-offs should be applied with regard to clinical decision making, especially at lower f-Hb levels.
Objectives: Currently, NICE recommends the use of faecal immunochemical test (FIT) at faecal haemoglobin concentrations (f-Hb) of 10 mu g 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 mu g 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: A total of 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 mu g Hb/g faeces for OC-S and 318.1 and 1.0 mu g 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<0.001. Using a f-Hb of 4 mu g Hb/g faeces for both tests found an agreement of 88.1%, at 10 mu g Hb/g faeces 91.7% and at 150 mu g Hb/g faeces 96.3%. A total of 114 individuals completed and returned two OC-S devices; correlation across the full range was rho=0.98, p<0.001. Conclusions: 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.
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