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Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer

  • Yanqin Huang , Weiting Ge , Viktoriya London , Qilong Li , Shanrong Cai , Suzhan Zhang and Shu Zheng EMAIL logo
Published/Copyright: June 12, 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 11

Abstract

Background: There is currently very little data available on the consistency of quantitative and qualitative faecal immunochemical test (FIT) for colorectal cancer screening.

Methods: A representative random population (n=1889, 40–74 year olds) in Jiashan, China was invited for FIT screening in 2012. Faecal samples were collected by a single specimen collection device and simultaneously tested by a quantitative FIT (OC-SENSOR, OC) and two qualitative FITs (FIT A and FIT B with intrinsic positive haemoglobin cut-off concentrations of 20 μg Hb/g faeces and 40 μg Hb/g faeces, respectively). The observational criteria for a positive result of the qualitative FIT were set according to the density of the colour appearing in the test strip. The results produced by the quantitative and qualitative FIT for each sample were compared. κ coefficient was used to measure consistency.

Results: A total of 1368 (72.4%) individuals returned faecal samples. Both FIT A and FIT B precisely identified all faecal samples with haemoglobin concentration above 100 μg Hb/g faeces, but the overall consistency was poor for OC & FIT A (κ=0.32, 95% CI 0.20–0.44) and was moderate for OC & FIT B (κ=0.74, 95% CI 0.64–0.85). A more favourable consistency (κ=0.64, 95% CI 0.57–0.72) was achieved when a different positive criterion was employed for FIT A.

Conclusions: The diagnostic inconsistency between quantitative and qualitative FITs mainly exists in the faecal samples with low haemoglobin concentrations. Refining the criterion for a positive result may be a feasible way to improve the accuracy of qualitative FIT.

Keywords: colorectal cancer screening; faecal immunochemical test; haemoglobin; quality assurance
Corresponding author: Shu Zheng, Jiefang Road No. 88, Hangzhou 310009, China, Phone: +86 57187784501, Fax: +86 57187214404, E-mail:

We thank Zhejiang Provincial Bureau of Health, Cancer Foundation of China, National Cancer Screening Committee of Ministry of Health for their contribution to make this research possible. We also thank Health Bureau of Jiashan County for providing assistance with this research.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding 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.

Research funding: National Key Technology R&D Program 2006BA102A00, China.

Colorectal Cancer Early Detection and Early Treatment Program of Zhejiang Province, China.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2013-02-06
Accepted: 2013-05-14
Published Online: 2013-06-12
Published in Print: 2013-11-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2013-0232
Keywords for this article
colorectal cancer screening; faecal immunochemical test; haemoglobin; quality assurance

Articles in the same Issue

  1. Letter to the Editor
  2. Elevated level of cell-free plasma DNA is associated with advanced-stage breast cancer and metastasis
  3. Is procalcitonin a reliable marker of sepsis in critically ill septic patients undergoing continuous veno-venous hemodiafiltration with “high cut-off” membranes (HCO-CVVHDF)?
  4. Challenging our serological algorithm for celiac disease (CD) diagnosis by the ESPGHAN guidelines
  5. Preanalytical quality control in a university hospital in China
  6. Racial differences and relationships between gestational thyrotropin and free thyroxine in a multiracial Asian population
  7. Analytical performance and method comparison study of the total homocysteine immunoassay on the AIA 600II analyser
  8. Easy verification of clinical chemistry reference intervals
  9. The Elecsys® Vitamin B12 assay is not affected by anti-intrinsic factor antibodies
  10. Chemiluminescence-based cobalamin assay errors: background and perspectives
  11. Congress Abstracts
  12. Abstracts IV Italian Great Network Congress Rome, 14th–18th October 2013*)
  13. Masthead
  14. Masthead
  15. Editorial
  16. Making colorectal cancer screening FITTER for purpose with quantitative faecal immunochemical tests for haemoglobin (FIT)
  17. From “panic” to “critical” values: which path toward harmonization?
  18. Review
  19. Cerebrospinal fluid analyses for the diagnosis of subarachnoid haemorrhage and experience from a Swedish study. What method is preferable when diagnosing a subarachnoid haemorrhage?
  20. Opinion Paper
  21. False myths and legends in laboratory diagnostics
  22. General Clinical Chemistry and Laboratory Medicine
  23. National survey on critical values notification of 599 institutions in China
  24. Influence of physical properties of cuvette surface on measurement of serum lipase
  25. Red cell indices: differentiation between β-thalassemia trait and iron deficiency anemia and application to sickle-cell disease and sickle-cell thalassemia
  26. Measurement of immature platelets with Abbott CD-Sapphire and Sysmex XE-5000 in haematology and oncology patients
  27. Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry
  28. Comparison of PR3-ANCA specific assay performance for the diagnosis of granulomatosis with polyangiitis (Wegener’s)
  29. The integration of the detection of systemic sclerosis-associated antibodies in a routine laboratory setting: comparison of different strategies
  30. Reference Values and Biological Variations
  31. Reference interval studies: what is the maximum number of samples recommended?
  32. Short-term estimation and application of biological variation of small dense low-density lipoproteins in healthy individuals
  33. Cancer Diagnostics
  34. Diagnostic inconsistency of faecal immunochemical tests for haemoglobin in population screening of colorectal cancer
  35. Cardiovascular Diseases
  36. Comparison of the 99th percentiles of three troponin I assays in a large reference population
  37. Assessment of plasma aminothiol levels and the association with recurrent atherothrombotic events in patients hospitalized for an acute coronary syndrome: a prospective study
  38. Diabetes
  39. The relationship between estimated average glucose and fasting plasma glucose
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