Abstract
Background: This study aimed to determine whether patients with lower abdominal symptoms can be investigated quickly using results of faecal haemoglobin concentration (f-Hb) measurements, and whether this test could form part of a diagnostic pathway for significant colorectal disease.
Methods: Nine hundred and nine consecutive patients referred from primary care for colonoscopy were invited: 507 submitted samples for f-Hb measurement with a quantitative faecal immunochemical test for haemoglobin (FIT) (HM-JACKarc, Kyowa-Medex, Japan) and a diagnostic colonoscopy was completed in 484 patients.
Results: Colorectal cancer (CRC), higher risk adenoma (HRA), inflammatory bowel disease (IBD) and/or colitis was found in 45 patients (9.3%); these had significantly higher (p<0.0001) f-Hb than the group of 243 with normal colonoscopy plus the 196 patients with less significant clinical findings. The 11 (2.2%) patients with CRC all had f-Hb >190 μg Hb/g faeces. Using a f-Hb cut-off of 10 μg Hb/g faeces, for the group with CRC or HRA or IBD or colitis, sensitivity was 68.9%, specificity 80.2%, positive predictive value (PPV) 26.3% and negative predictive value (NPV) 96.2%. Sensitivity and NPV were 100% for CRC suggesting f-Hb is a good rule-in test for CRC. Of the 243 patients with normal colonoscopy, 81.2% had f-Hb<10 μg Hb/g faeces.
Conclusions: The high NPV for significant colorectal diseases suggests that f-Hb could be used as a rule-out test in this context. Potential exists for using f-Hb measurements to investigate symptomatic patients and guide the use of colonoscopy resources: detailed algorithms for the introduction of f-Hb measurements requires further exploration.
Acknowledgments
Pauline Warnock and the staff of the NHS Lanarkshire Patient Centred Booking Service are thanked the distribution of the FIT devices and patient information. Professor Chris Robertson at the University of Strathclyde is thanked for his initial review of the data. Kyowa-Medex Co., Ltd, Tokyo, Japan, and Alpha Laboratories Ltd, Eastleigh, UK, are thanked for providing the loan of the analyser, all training and reagents, calibrators, controls and consumables. Yasunobu Masuda, Matthew Davis and Mairi White are thanked for their considerable help in the logistics required, for the loan of the automated analytical system and for their ongoing interest throughout the study.
Author contributions: The study was conceived by IMG, CGF and HBY. All authors participated in the design of the study, participated in data collection and analysis, commented on the implications of the results, and critically reviewed the final manuscript. LT performed the analytical testing and LM reviewed the endoscopy findings. IMG, CGF and HBY performed the data analysis and wrote the initial drafts of the manuscript. IMG is guarantor.
Ethical approval: The study was approved by the West of Scotland ethics service in February 2013 – reference 13/WS/0031.
Research funding: This research was supported, by NHS Lanarkshire; the analyser, training, reagents, calibrators, controls and consumables were fully supported by Kyowa-Medex Co., Ltd, Tokyo, Japan, and Alpha Laboratories Ltd, Eastleigh, Hants, UK.
Employment or leadership: None declared.
Competing interests: CGF has consultancy contracts with Kyowa-Medex Co., Ltd, Mode Diagnostic, Glasgow, Scotland, and Immunostics Inc., Ocean, NJ, USA, and received travel support from Alpha Labs Ltd; all other authors have no other relationships or activities that could appear to have influenced the submitted work. The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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