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A comparison of the faecal haemoglobin concentrations and diagnostic accuracy in patients suspected with colorectal cancer and serious bowel disease as reported on four different faecal immunochemical test systems

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Veröffentlicht/Copyright: 1. Juni 2022
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 60 Heft 8

Abstract

Objectives

Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer (CRC) screening programmes and to triage patients presenting with symptoms suggestive of CRC for further bowel investigations. There are a number of quantitative FIT analytical systems available. Currently, there is no harmonisation or standardisation of FIT methods. The aim of the study was to assess the comparability of numerical faecal haemoglobin concentrations (f-Hb) obtained with four quantitative FIT systems and the diagnostic accuracy at different f-Hb thresholds.

Methods

A subgroup of the National Institute for Health and Care Excellence (NICE) FIT study, a multicentre, prospective diagnostic accuracy study were sent four FIT specimen collection devices from four different FIT systems or two FIT devices for one FIT system. Faecal samples were examined and analysis of results carried out to assess difference between methods at thresholds of limit of detection (LoD), 10 µg haemoglobin/g faeces (µg/g) and 100 μg/g.

Results

233 patients returned specimen collection devices for examination on four different systems; 189 patients returned two FIT kits for one system. At a threshold of 100 μg/g the sensitivity is the same for all methods. At lower thresholds of LoD and 10 μg/g differences were observed between systems in terms of patients who would be referred and diagnostic accuracies.

Conclusions

The lack of standardisation or harmonisation of FIT means that differences are observed in f-Hb generated on different systems. Further work is required to understand the clinical impact of these differences and to minimise them.

Keywords: colorectal cancer; faecal haemoglobin; faecal immunochemical test; significant bowel disease; symptomatic patients
Corresponding author: Sally C. Benton, Clinical Biochemistry, Royal Surrey County Hospital, Berkshire and Surrey Pathology Services, Guildford, Surrey, UK; and NHS Bowel Cancer Screening South of England Hub, Berkshire and Surrey Pathology Services, 20 Priestley Road, Surrey Research Park, GU2 7YS, Guildford, Surrey, UK, Phone: +44 1483 409850, E-mail:
The NICE FIT Steering Group: Oliver Warren (Chelsea and Westminster Hospital NHS Foundation Trust); Saidyousuf Ahmadi, Carlene Parchment, Arun Shanmuganandan (Croydon University Hospital); Nicholas West (Epsom and St Helier University Hospitals); Toni Mitchell, Stephen Sah and Nick Jackson (Hammersmith Medical Research); Alistair Myers (Hillingdon Hospitals NHS Foundation Trust); Paul Ziprin (Imperial College Healthcare NHS Trust); Ian Bloom (Kingston Hospital NHS Foundation Trust); Stan Kaye (Royal Marsden Partners); Andy Ramwell (St George’s University Hospitals NHS Foundation Trust); John T Jenkins (St Mark’s Hospital); Kevin Monahan (West Middlesex University Hospital).

Acknowledgments

The study supported by Croydon University Hospital and RM Partners in the design and conduct of the trial. Patients were recruited nationally through the NIHR Clinical Research Network, Principal Investigators and R&D teams at each site. Alpha Labs Ltd supported the study prior to funding with FIT kits and production of patient information. We thank Professor Stephen Duffy for his guidance with some of the statistical methodology.

  1. Research funding: This study is a sub-study of the NICE FIT study which was funded by an NHS England award to RM Partners, the West London Cancer Alliance hosted by The Royal Marsden NHS Foundation Trust. The study was supported by the National Institute for Health Research Clinical Research Network Portfolio. Alpha Labs Ltd, MAST Diagnostics, Sysmex and Abbott/ Alfresa supported the study by providing FIT kits and reagents without charge. The study funders had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

  2. Author contributions: SCB drafted the manuscript. ZZ and CP carried out statistical analysis. CP, SOD and ZZ carried out laboratory analysis of samples. CGF provided guidance on statistical analysis. All authors provided significant input to the study, reviewed and revised drafts of the manuscript, and approved the submitted version. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013). The study was approved by the National Research Ethics Service Committee, London- South East. Full title: NICE Guidelines and The Faecal Immunochemical Test Study. REC No: 16/LO/2,174. IRAS project ID 218404.

  6. Principal investigators: Mark Austin (Brighton and Sussex University Hospitals NHS Trust); Gemma Faulkner (Bolton NHS Foundation Trust); John Stebbing (Royal Surrey NHS Foundation Trust); Jonathan Epstein (Salford Royal NHS Foundation Trust).

  7. Patient consent statement: No identifiable patient data is present in the manuscript, Permission to reproduce material from other sources, No material was reproduced from other sources.

  8. Permission to reproduce material from other sources: No material was reproduced from other sources.

  9. Clinical trial registration: ISRCTN49676259.

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Received: 2021-11-29
Accepted: 2022-05-17
Published Online: 2022-06-01
Published in Print: 2022-07-26

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2021-1248
Schlagwörter für diesen Artikel
colorectal cancer; faecal haemoglobin; faecal immunochemical test; significant bowel disease; symptomatic patients

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Transdermal measurement of cardiac troponins: the future is now
  4. Reviews
  5. Perinatal presepsin assessment: a new sepsis diagnostic tool?
  6. Hypertriglyceridemia, a causal risk factor for atherosclerosis, and its laboratory assessment
  7. Opinion Paper
  8. The novelties of the regulation on health technology assessment, a key achievement for the European union health policies
  9. General Clinical Chemistry and Laboratory Medicine
  10. Performance of four regression frameworks with varying precision profiles in simulated reference material commutability assessment
  11. Comparison of six regression-based lot-to-lot verification approaches
  12. Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model
  13. Evaluation of a pneumatic tube system carrier prototype with fixing mechanism allowing for automated unloading
  14. Analytical performance of eight enzymatic assays for ethanol in serum evaluated by data from the Belgian external quality assessment scheme
  15. Vitamin D metabolism in living kidney donors before and after organ donation
  16. Validation of steroid ratios for random urine by mass spectrometry to detect 5α-reductase deficiency in Vietnamese children
  17. Evaluation of serum neurofilament light in the early management of mTBI patients
  18. Assessment of urine sample quality by the simultaneous measurement of urinary γ-glutamyltransferase and lactate dehydrogenase enzyme activities: possible application to unravel cheating in drugs of abuse testing
  19. Reference Values and Biological Variations
  20. Age and sex specific reference intervals of 13 hematological analytes in Chinese children and adolescents aged from 28 days up to 20 years: the PRINCE study
  21. Cancer Diagnostics
  22. Prostate health index (PHI) as a reliable biomarker for prostate cancer: a systematic review and meta-analysis
  23. A comparison of the faecal haemoglobin concentrations and diagnostic accuracy in patients suspected with colorectal cancer and serious bowel disease as reported on four different faecal immunochemical test systems
  24. Circulating cell-free DNA undergoes significant decline in yield after prolonged storage time in both plasma and purified form
  25. Cardiovascular Diseases
  26. Analytical and clinical performance evaluation of a new high-sensitivity cardiac troponin I assay
  27. Infectious Diseases
  28. Results of a SARS-CoV-2 virus genome detection external quality assessment round focusing on sensitivity of assays and pooling of samples
  29. Letters to the Editors
  30. Improving D-dimer testing appropriateness by controlling periodicity of retesting: prevention is better than cure
  31. Biological variation of serum cholinesterase catalytic concentrations
  32. Three-month ad interim analysis of total anti-SARS-CoV-2 antibodies in healthy recipient of a single BNT162b2 vaccine booster
  33. Fibrin strands in peripheral blood smear: the COVID-19 era
  34. Fragments of alpha-1-antitrypsin in patients with severe COVID-19 and bacterial pulmonary sepsis
  35. Comparison of thyroid stimulating hormone, free thyroxine, total triiodothyronine, thyroglobulin and peroxidase antibodies measurements by two different platforms
  36. Effect of different incubation times on the detection of factor VIII inhibitor in acquired hemophilia A
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