An evaluation of ten external quality assurance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin
-
Shane O’Driscoll
,
Carolyn Piggott
,
Helen Bruce
Abstract
Objectives
External quality assessment schemes (EQAS) are being established worldwide to support the faecal immunochemical test (FIT) for haemoglobin (Hb). FIT is widely used as a screening test for colorectal cancer and increasingly in assessment of patients presenting with symptoms. EQA for FIT is provided in several matrices, each unique to the individual scheme. These include Hb suspended in a faecal-like matrix, lyophilised samples and liquid samples. The aim of this study was to evaluate commercially available EQAS and assess their suitability for use.
Methods
Ten EQAS provided material for the study. EQA samples were analysed on four quantitative FIT systems. 15 faecal-like matrix samples were loaded per concentration per FIT system. Reconstituted lyophilised samples were examined five times on three separate occasions and liquid samples were examined 10 times per concentration per FIT system. The coefficient of variation (CV) was calculated per concentration of EQA for each FIT system.
Results
Results from faecal-like matrix schemes had a higher median CV (12.4–19.0%) when compared to those from schemes providing liquid matrices (0.8–2.3%). The spread of CV values was also higher for results from faecal-like matrix schemes with an interquartile range (IQR) 4.4–24.0% vs. liquid IQR range of 0.3–2.5%.
Conclusions
Hb results from faecal-like matrices, whilst more aligned to a patient or participant sample, are prone to pre-examination variation so do not assess the analytical accuracy of a FIT system. Liquid matrices are not prone to pre-examination variation and are better able to assess the accuracy of a FIT system.
Acknowledgments
We thank FIT system suppliers HM-JACKarc: Alpha Laboratories, Eastleigh, Hampshire, UK; OC-SENSOR PLEDIA: Mast Diagnostics; Division, Bootle, Merseyside, UK; SENTiFIT 270: Sysmex UK Ltd, Milton; Keynes, Buckinghamshire, UK; NS-Prime: Alfresa Pharma Corp., Osaka, Japan for supplying the analysers and consumables, and each of the EQA schemes (listed in Table 2) for providing the materials for assessment.
Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
References
1. WHO. Cancer key facts 2018, September 12. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer [Accessed 10 Feb 2020].Search in Google Scholar
2. Saito, H. Colorectal cancer screening using immunochemical faecal occult blood testing in Japan. J Med Screen 2006;13 Suppl 1:S6–7.Search in Google Scholar
3. Navarro, M, Nicolas, A, Ferrandez, A, Lanas, A. Colorectal cancer population screening programs worldwide in 2016: an update. World J Gastroenterol 2017;2:3632–42. https://doi.org/10.3748/wjg.v23.i20.3632.Search in Google Scholar PubMed PubMed Central
4. National Institute for Health and Care Excellence. Quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care. Diagnostics guidance DG30. Available from: https://www.nice.org.uk/guidance/dg30 [Accessed 05 Feb 2020].Search in Google Scholar
5. ISO 15189:2012. Medical laboratories - Requirements for quality and competence. Geneva: ISO Publications; 2012.Search in Google Scholar
6. Benton, SC. IFCC – FIT working group (FIT-WG). IFCC e-news 2017:16–7. Available from: https://www.ifcc.org/media/461890/IFCCeNewsJune2017.pdf [Accessed 03 Feb 2020].Search in Google Scholar
7. Piggott, C, Shugaa, Z, Benton, SC. Independent internal quality control (IQC) for faecal immunochemical tests (FIT) for haemoglobin: use of FIT manufacturers’ IQC for other FIT systems. Clin Chem Lab Med 2021;59:e41–3. https://doi.org/10.1515/cclm-2020-0286.Search in Google Scholar PubMed
8. Fraser, CG, Allison, JE, Halloran, SP, Young, GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst 2012;104:810–4. https://doi.org/10.1093/jnci/djs190.Search in Google Scholar PubMed
9. Whitehead, TP, Browning, DM, Gregory, A. A comparative survey of the results of analyses of blood serum in clinical chemistry laboratories in the United Kingdom. J Clin Pathol 1973;26:435–45. https://doi.org/10.1136/jcp.26.6.435.Search in Google Scholar PubMed PubMed Central
10. UK NEQAS. Faecal markers of inflammation 2019. Available from: https://ukneqas.org.uk/programmes/result/?programme=faecal-markers [Accessed 03 Feb 2020].Search in Google Scholar
11. Roseth, AG, Fagerhol, MK, Aadland, E, Schjonsby, H. Assessment of the neutrophil dominating protein calprotectin in feces. a methodologic study. Scand J Gastroenterol 1992;27:793–8. https://doi.org/10.3109/00365529209011186.Search in Google Scholar PubMed
12. Mellen, S, de Ferrars, M, Chapman, C, Bevan, S, Turvill, J, Turnock, D. Evaluation of sample stability for a quantitative faecal immunochemical test and comparison of two sample collection approaches. Ann Clin Biochem 2018;55:657–64. https://doi.org/10.1177/0004563218766393.Search in Google Scholar PubMed
13. Ostrow, JD. Tests for fecal occult blood. In: Walker, HK, Hall, WD, JW, H, editors. Clinical methods: the history, physical, and laboratory examinations. 3rd ed. Boston: Butterworths; 1990, Chapter 98.Search in Google Scholar
14. Brown, LF, Fraser, CG. Effect of delay in sampling on haemoglobin determined by faecal immunochemical tests. Ann Clin Biochem 2008;45:604–5. https://doi.org/10.1258/acb.2008.008024.Search in Google Scholar PubMed
15. Fraser, CG, Benton, SC. Detection capability of quantitative faecal immunochemical tests for haemoglobin (FIT) and reporting of low faecal haemoglobin concentrations. Clin Chem Lab Med 2019;57:611–6. https://doi.org/10.1515/cclm-2018-0464.Search in Google Scholar PubMed
© 2020 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Assuring the quality of examinations using faecal immunochemical tests for haemoglobin (FIT)
- Review
- Capillary electrophoresis based on nucleic acid analysis for diagnosing inherited diseases
- Mini Reviews
- Negative hair test result after long-term drug use. About a case involving morphine and literature review
- Prorenin and active renin levels in paediatrics: a bioanalytical review
- Opinion Paper
- From therapeutic drug monitoring to total drug monitoring and drug-omics
- Perspectives
- The internal quality control in the traceability era
- Genetics and Molecular Diagnostics
- External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey
- General Clinical Chemistry and Laboratory Medicine
- An evaluation of ten external quality assurance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin
- Optimizing hepcidin measurement with a proficiency test framework and standardization improvement
- Development of a certified reference material for anti-β2-glycoprotein I IgG – commutability studies
- Influence of patients’ clinical features at intensive care unit admission on performance of cell cycle arrest biomarkers in predicting acute kidney injury
- Efficacy of weekly administration of cholecalciferol on parathyroid hormone in stable kidney-transplanted patients with CKD stage 1–3
- Plasma metanephrines and prospective prediction of tumor location, size and mutation type in patients with pheochromocytoma and paraganglioma
- Emicizumab, the factor VIII mimetic bi-specific monoclonal antibody and its measurement in plasma
- Reference Values and Biological Variations
- Age appropriate reference intervals for eight kidney function and injury markers in infants, children and adolescents
- Cardiovascular Diseases
- Comparison of acetylsalicylic acid and clopidogrel non-responsiveness assessed by light transmittance aggregometry and PFA-100® in patients undergoing neuroendovascular procedures
- Trimethylamine-N-oxide (TMAO) predicts short- and long-term mortality and poor neurological outcome in out-of-hospital cardiac arrest patients
- Non-lactate strong ion difference and cardiovascular, cancer and all-cause mortality
- Infectious Diseases
- Performance of three automated SARS-CoV-2 antibody assays and relevance of orthogonal testing algorithms
- Development, evaluation, and validation of machine learning models for COVID-19 detection based on routine blood tests
- Searching for a role of procalcitonin determination in COVID-19: a study on a selected cohort of hospitalized patients
- Association of kidney function with effectiveness of procalcitonin-guided antibiotic treatment: a patient-level meta-analysis from randomized controlled trials
- Erratum
- Corrigendum to: The role of hyperhomocysteinemia as well as folate, vitamin B6 and B12 deficiencies in osteoporosis – a systematic review
- Letter to the Editors
- Harmonization of antineutrophil cytoplasmic antibodies (ANCA) testing by reporting test result-specific likelihood ratios: position paper
- Independent internal quality control (IQC) for faecal immunochemical tests (FIT) for haemoglobin: use of FIT manufacturers’ IQC for other FIT systems
- Parallel testing of 241 clinical nasopharyngeal swabs for the detection of SARS-CoV-2 virus on the Cepheid Xpert Xpress SARS-CoV-2 and the Roche cobas SARS-CoV-2 assays
- Sustained SARS-CoV-2 nucleocapsid antibody levels in nonsevere COVID-19: a population-based study
- Evidence for increased circulating procoagulant phospholipids in patients with COVID-19 pneumonia and their prognostic role
- Complete blood counts and cell population data from Sysmex XN analyser in the detection of SARS-CoV-2 infection
- Macro creatine kinase in an asymptomatic patient: a case report
- Implementation of pre-labelled barcode tubes and the GeT-System in a general hospital for the exact documentation of the time of venous blood sample and improvement of sample quality
- Determination of free light chains: assay-dependent differences in interpretation
- Association between SOX17, Wif-1 and RASSF1A promoter methylation status and response to chemotherapy in patients with metastatic gastric cancer
- Effect of two organizational interventions on the frequency of haemoglobin A1c and erythrocyte sedimentation rate testing
- Haemoglobin A1c determination from dried blood spots prepared with HemaSpot™ blood collection devices: comparison with fresh capillary blood
- Stability of catecholamines in whole blood: influence of time between collection and centrifugation
Articles in the same Issue
- Frontmatter
- Editorial
- Assuring the quality of examinations using faecal immunochemical tests for haemoglobin (FIT)
- Review
- Capillary electrophoresis based on nucleic acid analysis for diagnosing inherited diseases
- Mini Reviews
- Negative hair test result after long-term drug use. About a case involving morphine and literature review
- Prorenin and active renin levels in paediatrics: a bioanalytical review
- Opinion Paper
- From therapeutic drug monitoring to total drug monitoring and drug-omics
- Perspectives
- The internal quality control in the traceability era
- Genetics and Molecular Diagnostics
- External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey
- General Clinical Chemistry and Laboratory Medicine
- An evaluation of ten external quality assurance scheme (EQAS) materials for the faecal immunochemical test (FIT) for haemoglobin
- Optimizing hepcidin measurement with a proficiency test framework and standardization improvement
- Development of a certified reference material for anti-β2-glycoprotein I IgG – commutability studies
- Influence of patients’ clinical features at intensive care unit admission on performance of cell cycle arrest biomarkers in predicting acute kidney injury
- Efficacy of weekly administration of cholecalciferol on parathyroid hormone in stable kidney-transplanted patients with CKD stage 1–3
- Plasma metanephrines and prospective prediction of tumor location, size and mutation type in patients with pheochromocytoma and paraganglioma
- Emicizumab, the factor VIII mimetic bi-specific monoclonal antibody and its measurement in plasma
- Reference Values and Biological Variations
- Age appropriate reference intervals for eight kidney function and injury markers in infants, children and adolescents
- Cardiovascular Diseases
- Comparison of acetylsalicylic acid and clopidogrel non-responsiveness assessed by light transmittance aggregometry and PFA-100® in patients undergoing neuroendovascular procedures
- Trimethylamine-N-oxide (TMAO) predicts short- and long-term mortality and poor neurological outcome in out-of-hospital cardiac arrest patients
- Non-lactate strong ion difference and cardiovascular, cancer and all-cause mortality
- Infectious Diseases
- Performance of three automated SARS-CoV-2 antibody assays and relevance of orthogonal testing algorithms
- Development, evaluation, and validation of machine learning models for COVID-19 detection based on routine blood tests
- Searching for a role of procalcitonin determination in COVID-19: a study on a selected cohort of hospitalized patients
- Association of kidney function with effectiveness of procalcitonin-guided antibiotic treatment: a patient-level meta-analysis from randomized controlled trials
- Erratum
- Corrigendum to: The role of hyperhomocysteinemia as well as folate, vitamin B6 and B12 deficiencies in osteoporosis – a systematic review
- Letter to the Editors
- Harmonization of antineutrophil cytoplasmic antibodies (ANCA) testing by reporting test result-specific likelihood ratios: position paper
- Independent internal quality control (IQC) for faecal immunochemical tests (FIT) for haemoglobin: use of FIT manufacturers’ IQC for other FIT systems
- Parallel testing of 241 clinical nasopharyngeal swabs for the detection of SARS-CoV-2 virus on the Cepheid Xpert Xpress SARS-CoV-2 and the Roche cobas SARS-CoV-2 assays
- Sustained SARS-CoV-2 nucleocapsid antibody levels in nonsevere COVID-19: a population-based study
- Evidence for increased circulating procoagulant phospholipids in patients with COVID-19 pneumonia and their prognostic role
- Complete blood counts and cell population data from Sysmex XN analyser in the detection of SARS-CoV-2 infection
- Macro creatine kinase in an asymptomatic patient: a case report
- Implementation of pre-labelled barcode tubes and the GeT-System in a general hospital for the exact documentation of the time of venous blood sample and improvement of sample quality
- Determination of free light chains: assay-dependent differences in interpretation
- Association between SOX17, Wif-1 and RASSF1A promoter methylation status and response to chemotherapy in patients with metastatic gastric cancer
- Effect of two organizational interventions on the frequency of haemoglobin A1c and erythrocyte sedimentation rate testing
- Haemoglobin A1c determination from dried blood spots prepared with HemaSpot™ blood collection devices: comparison with fresh capillary blood
- Stability of catecholamines in whole blood: influence of time between collection and centrifugation
